Otitis Media - Acute - NICE CKS

NICE Pathways
Evidence Services
Otitis media - acute

Last revised in July 2009
Otitis media - acute - Summary
Acute otitis media is infection of the middle ear.
It is a common problem in general practice, occurring mostly in younger children. It also occurs more often in children who are subject to passive
smoking, attend daycare (nursery), use formula milk (rather than breast milk), have craniofacial syndromes (such as Down's syndrome and cleft
palate), and in boys.
In older children, acute otitis media usually presents with earache. Younger children may pull or rub their ear, or they may have non-specific
symptoms such as fever, irritability, crying, poor feeding, restlessness at night, cough, or a runny nose. On examination the ear drum is distinctly
red, yellow, or cloudy. Occasionally the ear drum will be bulging.
Pain and fever can be managed with paracetamol or ibuprofen.
Most children with acute otitis media do not need antibiotics - symptoms will resolve spontaneously after a few days. Antibiotics may be necessary
for:
Children younger than 3 months.
Children who are systemically unwell.
Children who have already had symptoms for 4 days or more and they are not improving.
Young children with infection in both ears.
Children with perforation and/or discharge in the ear canal.
If an antibiotic is required, a 5-day course of amoxicillin is recommended.
The following groups of people need to be admitted to hospital for immediate specialist assessment:
Children younger than 3 months of age with a temperature of 38C or more.
Children 36 months of age with a temperature of 39C or more.
Adults and children with suspected acute complications of acute otitis media (AOM), such as meningitis, mastoiditis, or facial paralysis.
Some people experience recurrent episodes of acute otitis media. Each episode should be treated as an acute episode long-term antibiotics are
not recommended. Some things that may help prevent recurrence include:
Avoiding exposure to passive smoking.
Avoiding dummies.
Not feeding the child while lying flat.
Ensuring that the child has had a pneumococcal vaccination as part of the routine childhood immunisation schedule.
Have I got the right topic?
All ages
This CKS topic is based on a National Institute for Health and Care Excellence guideline, Prescribing of antibiotics for self-limiting respiratory tract
infections in adults and children in primary care [NICE, 2008a].
This CKS topic covers the diagnosis and management of acute otitis media and recurrent acute otitis media.
This CKS topic does not cover, in detail, the management of otitis media with effusion (glue ear), chronic suppurative otitis media, cholesteatoma,
otitis externa, acute mastoiditis, or other complications of acute otitis media.
There are separate CKS topics on Otitis externa, Otitis media - chronic suppurative, and Otitis media with effusion.
The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary health care.
How up-to-date is this topic?
Changes
Last revised in July 2009
August 2013 minor update. In Scenario: Acute diffuse otitis externa, the management node has been slightly reworded to clarify that in children
younger than 3 months there should be a low threshold for admitting the child or for prescribing antibiotics, as appropriate.
February 2013 minor update. The 2013 QIPP options for local implementation have been added to this topic [NICE, 2013].
October 2012 minor update. The 2012 QIPP options for local implementation have been added to this topic [NPC, 2012].
July 2011 minor update. More exact paracetamol dosing for children has been introduced by the Medicines and Healthcare products Regulatory
Agency [MHRA, 2011]. Prescriptions have been updated to reflect the revised dosing. Issued in July 2011.
May 2011 minor update. The 2010/2011 QIPP options for local implementation have been added to this topic [NPC, 2011]. Issued in June 2011.
April to July 2009 converted from CKS guidance to CKS topic structure. The evidence-base has been reviewed in detail, and recommendations
are more clearly justified and transparently linked to the supporting evidence.
The following important changes have been made to the previous CKS guidance:
In line with the National Institute for Health and Care Excellence guideline, Prescribing of antibiotics for self-limiting respiratory tract infections in
adults and children in primary care [NICE, 2008a], immediate antibiotics are no longer routinely recommended for:
All children younger than 6 months of age.
Children aged between 6 months and 2 years of age in whom the diagnosis of AOM is reasonably certain.
Children older than 2 years of age where there is moderate or severe earache with a fever of 39C or above or bilateral acute otitis media.
In line with the National Institute for Health and Care Excellence guideline, Feverish illness in children Assessment and initial management in
children younger than 5 years [National Collaborating Centre for Women's and Children's Health, 2007], admission for specialist assessment is now
recommended for:
Children younger than 3 months of age with a temperature of 38C or higher.
Children 36 months of age with a temperature of 39C or higher.
Previous changes
January 2009 minor update. Azithromycin added as a second-line antibiotic option for people who are allergic to penicillin, in line with updated
advice from the Health Protection Agency [HPA and Association of Medical Microbiologists, 2008]. Issued in February 2009.
July to September 2006 reviewed. Validated in December 2006 and issued in January 2007.
December 2007 updated. Macrolide choices for people with penicillin allergy changed to erythromycin and clarithromycin, in line with advice from
the Health Protection Agency. Issued in January 2008.
June 2007 update. Amoxicillin prescription corrected. Issued in June 2007.
October 2005 minor technical update. Issued in November 2005.

March 2004 updated the recommended dose of amoxicillin. Validated in March 2004 and issued in June 2004.
July 2003 rewritten. Validated in September 2003 and issued in October 2003.
March 2001 reviewed. Validated in July 2001 and issued in October 2001.
June 1999 reviewed.
April 1998 reviewed.
January 1997 written.
Update
New evidence
Evidence-based guidelines
Guidelines published since the last revision of this topic:
Liberthal, A.S., Carroll, A.E., Chonmaitree, T., era l. (2013) The diagnosis and management of acute otitis media. Pediatrics 131(3), e964-e999.
[Abstract]
HTAs (Health Technology Assessments)
No new HTAs since 1 February 2009.
Economic appraisals
No new economic appraisals relevant to England since 1 February 2009.
Systematic reviews and meta-analyses
Systematic reviews published since the last revision of this topic:
Abba, K., Gulani, A., and Sachdev, H.S. (2010) Zinc supplements for preventing otitis media (Cochrane Review). The Cochrane Library. Issue 2.
John Wiley & Sons, Ltd. www.thecochranelibrary.com [Free Full-text]
Azarpazhooh, A., Limeback, H., Lawrence, H.P. and Shah, P.S. (2011) Xylitol for preventing acute otitis media in children up to 12 years of age
(Cochrane Review). The Cochrane Library. Issue 11. John Wiley & Sons, Ltd. www.thecochranelibrary.com [Free Full-text]
Cheong, K.H. and Hussain, S.S. (2012) Management of recurrent acute otitis media in children: systematic review of the effect of different
interventions on otitis media recurrence, recurrence frequency and total recurrence time. Journal of Laryngology and Otology 126(9), 874-885.
[Abstract]
Coker, T.R., Chan, L.S., Newberry, S.J., et al. (2010) Diagnosis, microbial epidemiology, and antibiotic treatment of acute otitis media in children: a
systematic review. JAMA 304(19), 2161-2169. [Abstract]
Danhauer, J.L., Johnson, C.E., Corbin, N.E. and Bruccheri, K.G. (2010) Xylitol as a prophylaxis for acute otitis media: systematic review.
International Journal of Audiology 49(10), 754-761. [Abstract]
Gulani, A., Sachdev, H.P. and Qazi,S.A. (2010) Efficacy of short course (<4 days) of antibiotics for treatment of acute otitis media in children: a
systematic review of randomized controlled trials. Indian Pediatrics 47(1), 74-87. [Abstract] [Free Full-text (pdf)]
Jansen, A.G.S.C., Hak, E., Veenhoven, R.H., et al. (2009) Pneumococcal conjugate vaccines for preventing otitis media (Cochrane Review). The
Cochrane Library. Issue 2. John Wiley & Sons, Ltd. www.thecochranelibrary.com [Free Full-text]
Koopman, L., Hoes, A.W., Glasziou, P.P., et al. (2008) Antibiotic therapy to prevent the development of asymptomatic middle ear effusion in
children with acute otitis media: a meta-analysis of individual patient data. Archives of Otolaryngology - Head & Neck Surgery 134(2), 128-132.
[Abstract] [Free Full-text]
Levi, J.R., Brody, R.M., McKee-Cole, K., et al. (2013) Complementary and alternative medicine for pediatric otitis media. International Journal of
Pediatric Otorhinolaryngology 77(6), 926-931. [Abstract]
Lous, J., Ryborg, C.T. and Thomsen, J.L. (2011) A systematic review of the effect of tympanostomy tubes in children with recurrent acute otitis
media. International Journal of Pediatric Otorhinolaryngology 75(9), 1058-1061. [Abstract]
Pohlman, K.A. and Holton-Brown, M.S. (2012) Otitis media and spinal manipulative therapy: a literature review. Journal of Chiropractic Medicine
11(3), 160-169. [Abstract]
Thornton, K., Parrish, F., and Swords, C. (2011) Topical vs. systematic treatments for acute otitis media. Pediatric Nursing 37(5), 263-267.
[Abstract]
van den Aardweg, M.T.A., Schilder, A.G.M., Herkert, E., et al. (2010) Adenoidectomy for otitis media in children (Cochrane Review). The Cochrane
Library. Issue 1. John Wiley & Sons, Ltd. www.thecochranelibrary.com [Free Full-text]
Primary evidence
Randomized controlled trials published since the last revision of this topic:
Hoberman, A., Paradise, J.L., Rockette, H.E., et al. (2011) Treatment of acute otitis media in children under 2 years of age. New England Journal of
Medicine 364(2), 105-115. [Abstract] [Free Full-text]
Tahtinen, P.A., Laine, M.K., Huovinen, P., et al. (2011) A placebo-controlled trial of antimicrobial treatment for acute otitis media. New England
Journal of Medicine 364(2), 116-126. [Abstract] [Free Full-text]
Observational studies published since the last revision of this topic:
Smith, L., Ewings, P., Smith, C., et al. (2010) Ear discharge in children presenting with acute otitis media: observational study from UK general
practice. British Journal of General Practice 60(571), 101-105. [Abstract] [Free Full-text]
A prospective follow-up study has been published since the last revision of this topic:
Bezakova, N., Damoiseaux, R.A.M.J., Hoes, A.W., et al. (2009) Recurrence up to 3.5 years after antibiotic treatment of acute otitis media in very
young Dutch children: survey of trial participants. BMJ 338, b2525. [Abstract] [Free Full-text]
New policies
No new national policies or guidelines since 1 February 2009.
New safety alerts
No new safety alerts since 1 February 2009.
Changes in product availability
No changes in product availability since 1 February 2009.
Goals and outcome measures
Goals
Making an accurate diagnosis
Appropriate treatment in primary care settings, in particular appropriate (usually no or delayed) antibiotic prescribing
Appropriate admission or referral to secondary care
QIPP Options for local implementation
Non-steroidal anti-inflammatory drugs (NSAIDs)
Review the appropriateness of NSAID prescribing widely and on a routine basis, especially in people who are at higher risk of both
gastrointestinal (GI) and cardiovascular (CV) morbidity and mortality (e.g. older patients).
If initiating an NSAID is obligatory, use ibuprofen (1200 mg per day or less) or naproxen (1000 mg per day or less).
Review patients currently prescribed NSAIDs. If continued use is necessary, consider changing to ibuprofen (1200 mg per day or less) or
naproxen (1000 mg per day or less).
Review and, where appropriate, revise prescribing of etoricoxib to ensure it is in line with MHRA advice and the NICE clinical guideline on
osteoarthritis [CSM, 2005; NICE, 2008b].
Co-prescribe a proton pump inhibitor (PPI) with NSAIDs for people with osteoarthritis, rheumatoid arthritis, or low back pain (for people over 45
years) in accordance with NICE guidance [NICE, 2008b; NICE, 2009a; NICE, 2009b].
Take account of drug interactions when co-prescribing NSAIDs with other medicines (see Summaries of Product Characteristics). For example,
co-prescribing NSAIDs with ACE inhibitors or angiotensin receptor blockers (ARBs) may pose particular risks to renal function; this combination
should be especially carefully considered and regularly monitored if continued.
Antibiotic prescribing especially quinolones and cephalosporins
Review and, where appropriate, revise current prescribing practice and use implementation techniques to ensure prescribing is in line with
Health Protection Agency (HPA) guidance.
Review the total volume of antibiotic prescribing against local and national data.
Review the use of quinolones and cephalosporin prescribing against local and national data.
[NICE, 2013]
Background information
Definition
What is it?
Acute otitis media (AOM) is infection of the middle ear, characterized by the presence of middle ear effusion associated with the acute onset of
symptoms and signs of middle ear inflammation [American Academy of Pediatrics, 2004; Bradley-Stevenson et al, 2008].
Recurrent AOM is generally defined as three or more episodes of AOM in 6 months, or four or more episodes in a year, with an absence of
middle ear disease between episodes [Alberta Medical Association, 2008; ICSI, 2008; McDonald et al, 2008]. However, there is no universal
definition.
Persistent AOM (treatment failure) is defined, for the purposes of this CKS topic, as occurring when people return for medical advice with the
same episode of AOM, either because symptoms persist after initial management (no-antibiotics, delayed-antibiotics, or immediate-antibiotics
prescribing strategy), or because symptoms are worsening [American Academy of Pediatrics, 2004].
It should be differentiated from otitis media with effusion and chronic suppurative otitis media (see the CKS topics on Otitis media with effusion,
and Otitis media - chronic suppurative).
Causes
What causes it?
Both viruses and bacteria can cause acute otitis media (AOM), and commonly both are present. There are too few reports to accurately
estimate the proportions of each.
The most common bacterial pathogens associated with AOM are Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella
catarrhalis [Rovers et al, 2004].
Following the introduction of pneumococcal vaccination, the most common bacterial pathogen may be changing from Streptococcus
pneumoniae to Haemophilus influenzae [Block et al, 2004; Casey and Pichichero, 2004].
When AOM is associated with Haemophilus influenzae, non-typable strains are most common; only 10% are due to type B and are potentially
preventable by the Haemophilus influenzae type B (HIB) vaccine [Klein, 2005].
The most common viral pathogens associated with AOM are respiratory syncytial virus and rhinovirus [Rovers et al, 2004].
The causative pathogens in recurrent AOM are thought to be similar to those in non-recurrent AOM.
There is some evidence from non-UK studies that pathogens in recurrent AOM are more frequently resistant to antibiotics compared with
pathogens in children with non-recurrent AOM not recently treated with antibiotics. It is not clear whether these findings can be extrapolated to
the UK.
Around three-quarters of recurrences of AOM occurring within 1 month of completing antibiotic treatment for an initial episode of AOM are due to
new pathogens [Leibovitz, 2007].
Risk factors
What are the risk factors?
Acute otitis media (AOM) most commonly affects younger children.
Peak incidence is between 6 and 15 months of age [Sanders et al, 2004].
Over 75% of episodes of AOM occur in children younger than 10 years of age [SIGN, 2003].
Risk factors for AOM, besides young age, include [Uhari et al, 1996; Shah, 2003; Alberta Medical Association, 2008]:
Passive smoking.
Daycare (nursery) attendance.
Use of formula milk (rather than breast milk).
Craniofacial syndromes (such as Down's syndrome and cleft palate).
Male sex.
Genetics.
Risk factors for recurrent AOM include [Froom et al, 1990; American Academy of Pediatrics, 2004; Damoiseaux et al, 2006; Lubianca Neto et al,
2006; Alberta Medical Association, 2008; Rovers et al, 2008]:
Early age of first episode of AOM, particularly before 6 months of age.
Dummy (pacifier) use.
Daycare (nursery) attendance.
Passive smoking.
Flat, supine feeding.
Winter season.
Male sex.
AOM episode lasting for more than 10 days.
History of not having been breastfed for at least 3 months.
Craniofacial abnormalities.
Presence of adenoids.
Prognosis
What is the prognosis?
After an initial episode of acute otitis media (AOM):
If recurrence occurs, it is most likely to occur within a few weeks [Leibovitz, 2007].
Around half of all children who are treated with antibiotics develop one or more new episodes in the following 3 months [Bluestone, 2000].
Infants and children have, on average, three episodes of AOM in the following year [Bluestone, 2000].
Complications
What are the complications?
Possible long-term consequences of recurrent acute otitis media include hearing loss, chronic perforation and otorrhoea, chronic
suppurative otitis media, cholesteatoma, and problems arising from intracranial complications of otitis media [Bluestone, 2000].
Diagnosis
Diagnosis of acute otitis media
Diagnosis
How do I make a diagnosis of acute otitis media?
Diagnose acute otitis media if there is:
Acute onset of symptoms, including:
In older children and adults earache.
In younger children pulling, tugging, or rubbing of the ear, or non-specific symptoms (such as fever, irritability, crying, poor feeding,
restlessness at night, cough, or rhinorrhoea).
On examination:
A distinctly red, yellow, or cloudy tympanic membrane.
The diagnosis is strengthened by the presence of at least one of the following:
Bulging of the tympanic membrane, with loss of normal landmarks.
An air-fluid level behind the tympanic membrane (although this may be difficult to detect).
Perforation of the tympanic membrane and/or discharge (otorrhoea) in the external auditory canal.
Consider whether findings may be explained by other causes of middle ear inflammation or effusion.
Additional information
Children younger than 6 months of age (and particularly younger than 3 months of age)
Diagnosis can be difficult and there may be coexisting serious illness.
Symptoms are likely to be non-specific.
The tympanic membrane is often not visible; it often lies in an oblique position and the ear canal is small and tends to collapse.
Acute otitis media may occur in association with bronchiolitis, bacteraemia, meningitis, or other systemic illness.
[Froom et al, 1990; Barnett, 2003; American Academy of Pediatrics, 2004; Alberta Medical Association, 2008; Berkun et al, 2008]
Basis for recommendation
In the absence of universally accepted, validated diagnostic criteria for acute otitis media (AOM) [Chandler et al, 2007; Powers, 2007],
recommendations for its diagnosis are based on a systematic review [Rothman et al, 2003]; a prospective diagnostic study [Niemela et al, 1994];
Scottish, US, and regional Canadian guidelines [SIGN, 2003; American Academy of Pediatrics, 2004; Alberta Medical Association, 2008]; and an
evidence-based, narrative review on the diagnosis and treatment of AOM [Powers, 2007].
Limited evidence from a systematic review suggests that the most accurate individual symptoms and signs for diagnosing AOM are ear pain; ear
rubbing; a cloudy or distinctly red or bulging tympanic membrane; or a distinctly immobile tympanic membrane (on pneumatic otoscopy) [Rothman
et al, 2003]. Fever, upper respiratory tract symptoms, crying, restless sleep, and irritability are individually less useful, but no studies have
assessed the accuracy of several symptoms and signs combined. These findings are limited by bias in the studies included in the review.
The American Academy of Pediatrics guideline also recommends the use of pneumatic otoscopy to assess mobility of the tympanic membrane
[American Academy of Pediatrics, 2004], but this is not routinely used or available in UK primary care.
Differential diagnosis
What else might it be?
Consider these other causes of middle ear inflammation or effusion:
Other upper respiratory tract infections mild redness of the tympanic membrane may be seen.
Crying in a child redness of the tympanic membrane is temporary and self-limiting.
Otitis media with effusion (glue ear) fluid in the middle ear without signs or symptoms of acute inflammation of the tympanic membrane.
See the CKS topic on Otitis media with effusion.
Chronic suppurative otitis media persistent inflammation and perforation of the tympanic membrane with draining exudate for more than 2
6 weeks (depending on the definition used). There may be an associated cholesteatoma. See the CKS topic on Otitis media - chronic
suppurative.
Acute mastoiditis (rare) clinical features that can help to differentiate mastoiditis from acute otitis media include:
Swelling, tenderness, and redness over the mastoid bone (behind the ear). Tenderness over the mastoid is also found in upper respiratory
tract infections due to tender post-auricular lymph nodes.
Displacement, outwards and downwards, of the pinna (best viewed from behind).
Narrowing of the external auditory canal.
Bullous myringitis (rare) haemorrhagic bullae (blisters) on the tympanic membrane caused by Mycoplasma pneumoniae (90% spontaneous
resolution rate).
This list of differential diagnoses is derived from a systematic review of diagnostic criteria for acute mastoiditis in children [van den Aardweg et al,
2008], a textbook [Klein, 2005], a narrative review [Hart, 2006], and a regional Canadian guideline [Alberta Medical Association, 2008].
Management
Scenario: Acute otitis media - initial presentation : covers the management of people presenting to a primary healthcare professional for the
first time during an episode of AOM.
Scenario: Recurrent acute otitis media : covers the management in primary care of people with three or more episodes of AOM in the previous
6 months, or four or more episodes in the previous 12 months, who are free of disease between episodes.
Scenario: Persistent acute otitis media - treatment failure : covers the management of people returning for medical advice with the same
episode of AOM, either because symptoms of AOM persist after initial management (no antibiotic, delayed antibiotic, or immediate antibiotic
prescribing), or because symptoms are worsening.
Scenario: Acute otitis media - initial presentation
All ages
Management
How should I manage people at initial presentation?
Consider whether admission or referral is necessary.
For children younger than 3 months of age with acute otitis media (AOM), have a low threshold for admitting.
Treat pain and fever with paracetamol or ibuprofen if there are no contraindications. See the CKS topic on Feverish children - management.
Consider whether antibiotics are required:
For most people with suspected acute AOM, advise a no antibiotic prescribing strategy or a delayed antibiotic prescribing strategy.
For children younger than 3 months of age with AOM, have a low threshold for prescribing antibiotics.
Offer an immediate antibiotic prescription to:
People who are systemically very unwell (but who do not require admission).
People at high risk of serious complications because of significant heart, lung, renal, liver, or neuromuscular disease, immunosuppression, or
cystic fibrosis, and young children who were born prematurely.
People whose symptoms of AOM have already lasted for 4 days or more and are not improving.
Depending on severity, consider offering an immediate antibiotic prescription to:
Children younger than 2 years of age with bilateral AOM.
Children with perforation and/or discharge in the ear canal (otorrhoea) associated with AOM.
Offer advice appropriate to the antibiotic prescribing strategy.
If an antibiotic prescription is required, see Antibiotic regimen.
Prescribing strategies
For all antibiotic prescribing strategies:
Inform the person that the average total duration of illness for untreated acute otitis media, before and after seeing a healthcare professional, is
4 days.
When a no antibiotic prescribing strategy is adopted:
Offer reassurance that antibiotics are not usually needed because they are likely to make little difference to symptoms, may have adverse
effects (for example, diarrhoea, vomiting, and rash), and can contribute to antibiotic resistance.
Advise the person to re-consult if the condition worsens or if symptoms are not starting to settle within 4 days of the onset of the illness.
When a delayed antibiotic prescribing strategy is adopted:
A delayed prescription, with instructions, can either be given to the person or their parent/carer, or left at an agreed location (such as the
practice reception) to be collected at a later date.
Offer reassurance that antibiotics are not usually needed because they are likely to make little difference to symptoms, may have adverse
effects (for example, diarrhoea, vomiting, and rash), and can contribute to antibiotic resistance.
Advise that antibiotics should be started if symptoms are not starting to settle within 4 days of the onset of the illness or if there is a significant
worsening of symptoms at any time.
Advise the person to re-consult if symptoms persist despite completing a course of antibiotics or if there is a significant worsening of symptoms at
any time.
When an immediate antibiotic prescribing strategy is adopted:
Advise the person to re-consult if symptoms persist despite completing a course of antibiotics or if there is a significant worsening of symptoms at
any time.
These recommendations are in line with the National Institute for Health and Clinical excellence (NICE) guidelines, Prescribing of antibiotics for self-
limiting respiratory tract infections in adults and children in primary care [NICE, 2008a] and Feverish illness in children Assessment and initial
management in children younger than 5 years [National Collaborating Centre for Women's and Children's Health, 2007].
Treat pain and fever
There is evidence that paracetamol and ibuprofen are both efficacious in relieving pain in children with acute otitis media. Both drugs have good
safety profiles and few adverse effects when used at recommended doses.
This is also a recommendation in the NICE guideline, Prescribing of antibiotics for self-limiting respiratory tract infections in adults and children in
primary care [NICE, 2008a].
No antibiotic prescribing or delayed antibiotic prescribing
Although there is evidence that antibiotics significantly reduce pain and fever after 27 days compared with placebo, and limited evidence from an
observational study that they reduce the risk of mastoiditis (in children with AOM), there are good reasons not to recommend the routine use of
immediate antibiotic prescribing:
The benefits are marginal.
Fifteen children need to be treated to prevent one child experiencing pain on days 27.
Nearly 5000 children with otitis media would need to be treated to prevent one episode of mastoiditis. Most children make an uncomplicated
recovery from mastoiditis with treatment.
There is an increased risk of adverse effects and the development of antibiotic resistance.
There is evidence that a delayed antibiotic prescribing strategy reduces the consumption of antibiotics, the intention to consult a doctor for
future episodes, and the likelihood of adverse effects (mainly diarrhoea), without appearing to increase the long-term risk of mastoiditis,
recurrent earache, or hearing problems. This is at the expense of a short delay in recovery of (at most) 1 day, increased analgesic
requirements, and only a small reduction in parental satisfaction with treatment.
Immediate antibiotic prescribing
The recommendation to offer immediate antibiotics to adults and children who appear systemically very unwell or who are at high risk of
complications is based on the opinion of the NICE Guideline Development Group [NICE, 2008a]. There is insufficient published evidence to
determine if any groups of people are at higher risk of developing complications or whether antibiotic use is more effective for people who are
systemically unwell.
The recommendation to offer an immediate antibiotic prescription to people whose symptoms have already lasted for more than 4 days and are not
improving is extrapolated from recommendations in:
The NICE guideline about advice on the average length of illness for AOM (4 days) and when to commence antibiotics when a delayed
prescribing strategy is adopted [NICE, 2008a].
Other guidelines about the use of antibiotics for persistent AOM [American Academy of Pediatrics, 2004; University of Michigan Health System,
2007; Alberta Medical Association, 2008; ICSI, 2008].
There is evidence from a systematic review that children younger than 2 years of age with bilateral AOM and children with AOM who have
otorrhoea (irrespective or age or laterality of disease) benefit most from antibiotics (number needed to treat 4).
Children 36 months of age, and adults
The recommendations for managing children 36 months of age and adults have been extrapolated from the evidence in children older than
6 months of age.
There is a lack of evidence on antibiotics and antibiotic prescribing strategies for AOM in these groups.
People with craniofacial abnormalities (including cleft palate and Down's syndrome)
There is insufficient evidence to make any recommendations on the most appropriate management of people with craniofacial abnormalities. These
people have been specifically excluded from trials of antibiotic efficacy.
A Canadian guideline states that these people are at risk of complications [British Columbia Medical Association, 2004].
A CKS expert reviewer said he was not aware that children with craniofacial abnormalities may be at higher risk of complications.
The author of a textbook stated that people with craniofacial syndromes are at higher risk of developing AOM and otitis media with effusion
[Shah, 2003].
Prescribing strategies
Advice for individuals and parents in relation to antibiotic strategies is mainly derived from the NICE guideline, Prescribing of antibiotics for self-
limiting respiratory tract infections in adults and children in primary care [NICE, 2008a].
The recommendation to advise that the use of antibiotics can contribute to antimicrobial resistance is based on Health Protection Agency
documents [HPA, 2005; HPA and Association of Medical Microbiologists, 2008].
Follow up
When is follow up required?
Routine follow up is not required in the absence of persistent symptoms.
Follow up is required:
When a no antibiotic prescribing strategy is adopted, if there is significant worsening of symptoms or if symptoms are not starting to settle within
4 days of the onset of the illness.
When a delayed or an immediate antibiotic prescribing strategy is adopted, if symptoms persist despite completing a course of antibiotics, or if
there is significant worsening of symptoms at any time.
If discharge from the ear canal (otorrhoea) persists for 2 weeks see the CKS topic on Otitis media - chronic suppurative.
If perforation has occurred, but discharge from the ear canal has resolved, at 6 weeks.
If hearing loss persists in the absence of pain or fever see the CKS topic on Otitis media with effusion.
For recurrent acute otitis media see Scenario: Recurrent acute otitis media.
These recommendations are in line with the National Institute for Health and Care Excellence guideline, Prescribing of antibiotics for self-limiting
respiratory tract infections in adults and children in primary care [NICE, 2008a].
The recommendation to follow up people with otorrhoea that persists for 2 weeks is made on the basis that these people may have chronic
suppurative otitis media, for which referral is required (see the CKS topic on Otitis media - chronic suppurative), and on the basis of comments from
CKS expert reviewers.
The recommendation to follow up people with a dry perforation at 6 weeks is based on a Canadian regional guideline which recommends referral
[British Columbia Medical Association, 2004]. The Scottish Intercollegiate Guidelines Network (SIGN) also recommends referral but does not specify
a time period [SIGN, 2003].
Antibiotic regimen
Which antibiotic regimen should I prescribe?
If an antibiotic is required:
Prescribe a 5-day course of amoxicillin 40 mg/kg/day in divided doses, that is 13.3 mg/kg three times a day (up to a maximum of 1 g three times
a day).
This most closely equates to double-dose amoxicillin when prescribed by age, see Prescriptions.
For people who are allergic to penicillin, prescribe a 5-day course of clarithromycin or erythromycin.
Choice of antibiotic
Recommendations on the choice of antibiotic are based on Management of infection guidance for primary care for consultation and local
adaptation from the Health Protection Agency (HPA) and the Association of Medical Microbiologists [HPA and Association of Medical
Microbiologists, 2008].
Amoxicillin is effective against the likely bacterial pathogens involved in otitis media (Streptococcus pneumoniae, Haemophilus influenzae,
Moraxella catarrhalis).
Erythromycin or clarithromycin are recommended only for people unable to take penicillin as they are less effective against H. influenzae. These
drugs concentrate intracellularly, but H. influenzae is an extracellular pathogen.
Clarithromycin is generally better tolerated than erythromycin and is more convenient (taken twice daily rather than four times daily) [DTB,
1991].
The cost difference for tablets is marginal if antibiotics are rarely used. Clarithromycin suspension is more expensive than erythromycin
suspension.
Co-amoxiclav and azithromycin should be reserved for people who have not responded to a first-line antibiotic. Broad spectrum antibiotics (such
as co-amoxiclav) should be avoided when narrow spectrum antibiotics are likely to be effective, as they increase the risk of Clostridium difficile
and meticillin-resistant Staphylococcus aureus (MRSA). Azithromycin is not recommended as a first-line antibiotic because it has a long half-life
which increases the risk of developing antibiotic resistance.
Dose of antibiotic
Amoxicillin 40 mg/kg/day (13.3 mg/kg three times a day) is recommended by the British National Formulary for the treatment of otitis media in
children [BNF 57, 2009].
This is an off-label dose of amoxicillin. A variety of doses have been used in clinical trials of otitis media, but 4050 mg/kg/day has been used
fairly consistently in recent times [Rodriguez et al, 1990; Johnson et al, 1991; Principi and Marchisio, 1991; Mohs et al, 1993; Murph et al, 1993;
Pukander et al, 1993; Scholz and Noack, 1998; Damoiseaux et al, 2000; Guggenbichler et al, 2000; Garrison et al, 2004]. CKS was unable to
identify a systematic review that evaluated doses of antibiotics in otitis media.
Higher doses (8090 mg/kg/day) have been used in some clinical trials in an effort to overcome resistance to Streptococcus pneumoniae
[Piglansky et al, 2003; Arguedas et al, 2005; Casellas et al, 2005]. However, this is not thought to be a widespread problem in the UK.
Clarithromycin is specifically licensed for use in otitis media at a dose of 7.5 mg/kg twice a day [ABPI Medicines Compendium, 2006].
Erythromycin has been studied comparatively rarely [Howie and Ploussard, 1972; Scholz and Noack, 1998], but has traditionally been used at the
licensed dose in the UK.
Duration of antibiotic
The 5-day duration of antibiotic regimens is based on Management of infection guidance for primary care for consultation and local adaptation
from the Health Protection Agency (HPA) and the Association of Medical Microbiologists [HPA and Association of Medical Microbiologists, 2008] and
evidence from a Cochrane systematic review [Kozyrskyj et al, 2000].
Referral or admission
When should I refer or admit?
Admit for immediate specialist assessment:
Children younger than 3 months of age with a temperature of 38C or more, and children 36 months of age with a temperature of 39C or more
(for paediatric assessment see the CKS topic on Feverish children - management).
Adults and children with suspected acute complications of acute otitis media (AOM), such as meningitis, mastoiditis, or facial paralysis.
Consider admitting:
People who are systemically very unwell.
Have a low threshold for admitting children younger than 3 months of age with suspected AOM.
In adults with repeated AOM (for example, two episodes in 1 year), consider the possibility of nasopharyngeal cancer (rare, but refer urgently if
it is suspected), especially in the presence of any one of the following:
Persistent symptoms and signs of otitis media with effusion in between episodes. See the CKS topic on Otitis media with effusion.
Cervical lymphadenopathy.
Unilateral epistaxis.
Referral may be needed for:
People with recurrent AOM (three or more episodes of AOM in 6 months, or four or more episodes in a year, with an absence of middle ear
disease between episodes) see Scenario: Recurrent acute otitis media.
Recommendations on admission and referral of people with acute otitis media (AOM) and its complications are mainly derived from National Institute
for Health and Clinical Excellence (NICE) guidelines [National Collaborating Centre for Women's and Children's Health, 2007; NICE, 2008a], a Scottish
Intercollegiate Guidelines Network (SIGN) guideline [SIGN, 2003], and North American guidelines [University of Michigan Health System, 2007; Alberta
Medical Association, 2008; ICSI, 2008], or are pragmatic advice.
Admission
The recommendation to admit people with acute complications of AOM is pragmatic and based on guidelines from SIGN and the US Institute for
Clinical Systems Improvement [SIGN, 2003; ICSI, 2008].
The recommendations to admit children younger than 3 months of age with a temperature of 38C or more, and children 36 months of age with a
temperature of 39C or more, are based on the NICE guideline, Feverish illness in children Assessment and initial management in children
younger than 5 years [National Collaborating Centre for Women's and Children's Health, 2007]. See the CKS topic on Feverish children -
management.
The recommendation to consider admitting people who are systemically very unwell is pragmatic, and implied by the NICE guideline, Prescribing of
antibiotics for self-limiting respiratory tract infections in adults and children in primary care [NICE, 2008a].
Evidence on the most appropriate management of children younger than 3 months of age with suspected AOM is limited or conflicting. The NICE
guideline, Prescribing of antibiotics for self-limiting respiratory tract infections in adults and children in primary care, excludes children younger than
3 months of age in its scope [NICE, 2008a]. A low threshold for admission or prescribing immediate antibiotics is recommended on the basis of
expert opinion expressed in North American guidelines [University of Michigan Health System, 2007; Alberta Medical Association, 2008] and a
textbook [Barnett, 2003] that AOM may be associated with bacteraemia, meningitis, or other systemic illness in these children.
However, in a study of 67 infants admitted to an Israeli hospital and diagnosed with AOM, none were subsequently found to have meningitis or
bacteraemia [Sakran et al, 2006].
Adults with repeated AOM
The recommendation to consider the possibility of nasopharyngeal cancer in adults with repeated AOM, and to refer urgently if suspected, is based
on a US guideline [University of Michigan Health System, 2007], and on published expert opinion in a textbook [Chi et al, 2003], which advise
referral of adults with recurrent AOM.
The US guideline does not define recurrent AOM. It is usually defined as three or more episodes of AOM in 6 months, or four or more episodes
in a year. CKS recommends that if malignancy is suspected, it is not appropriate to delay referral to meet these criteria.
The features suggestive of a nasopharyngeal cancer are based on expert opinion in a textbook [Calhoun, 2001] and from a CKS expert
reviewer.
Scenario: Recurrent acute otitis media
All ages
Managing acute episodes
How do I manage acute episodes in people with recurrent acute otitis media?
In general, manage acute episodes of acute otitis media (AOM) in the same way as for non-recurrent AOM see Scenario: Acute otitis
media - initial presentation and Scenario: Persistent acute otitis media - treatment failure.
Consider whether referral or admission is needed.

Treat pain and fever with paracetamol or ibuprofen if there are no contraindications.
Advise a no antibiotic prescribing strategy or a delayed antibiotic prescribing strategy for most people presenting with AOM.
Offer an immediate antibiotic prescription to people who are likely to be at high risk of complications or who have persistent symptoms.
If symptoms worsen or persist, start an antibiotic or change it.
If an antibiotic prescription is required, treat as for non-recurrent AOM see Antibiotic regimen.
In people with grommets (ventilation tubes) who present with acute discharge:
Consider taking a swab for culture and sensitivity.
Treat as above or seek advice from an ear, nose, and throat specialist.
Additional information
People at high risk of complications
People at high risk of serious complications include those with significant heart, lung, renal, liver, or neuromuscular disease, immunosuppression,
or cystic fibrosis, and young children who were born prematurely [NICE, 2008a].
General management of people with recurrent episodes of acute otitis media (AOM)
In the absence of good evidence on the efficacy, harms, choice, dose, or duration of antibiotics for episodes of AOM in people with recurrent AOM,
or on the prognosis of untreated AOM in this group, recommendations on antibiotic prescribing are based on guidance from the National Institute
for Health and Care Excellence (NICE) [NICE, 2008a].
NICE concluded that people with recurrent AOM should not be excluded from the offer of a delayed or no antibiotic prescribing strategy [NICE,
2008a].
Further justification for this approach comes from consensus that the routine use of antibiotics is likely to contribute further to antibiotic
resistance [HPA, 2005; NICE, 2008a], which may make treatment of subsequent, severe episodes of AOM more difficult.
Management of people with grommets (ventilation tubes)
There is insufficient evidence on the most effective treatment of AOM in people with grommets (ventilation or tympanostomy tubes).
The high rate of Pseudomonas organisms (40%) detected in one trial suggests that taking a swab for culture and sensitivity should be
considered [Schmelzle et al, 2008].
Seeking specialist advice is recommended as an alternative to routine management on the basis that several CKS expert reviewers advise the
use of topical aminoglycosides in this group. Although a consensus statement by ENT-UK supports cautious use of topical aminoglycosides
[Phillips et al, 2007], there is insufficient evidence to recommend their use and the Committee on Safety of Medicines has stated that topical
treatment with ototoxic antibacterials is contraindicated in the presence of a perforation [CSM, 1997]. For further information, see the section on
Adverse effects and harms of treatments in the CKS topic on Otitis externa.
There is low quality evidence that topical fluoroquinolones are superior to oral antibiotics, but they are not available in the UK apart from on a
named-patient basis [BNF 57, 2009].
Preventing further episodes
How do I prevent further acute episodes?
Advise:
Eliminating passive smoking.
Avoiding dummies (pacifiers).
Avoiding flat, supine feeding.

In children, if possible, catching up on any missed pneumococcal vaccinations if they were not received during the routine childhood
immunization schedule.
A period of observation with reassurance that the frequency of recurrence reduces as a child gets older.
Refer for a routine appointment with an ear, nose, and throat specialist if any of the following apply:
The person has a craniofacial syndrome (such as cleft palate or Down's syndrome).
The conservative measures above are ineffective or not feasible.
Recurrent episodes are intolerable or associated with complications.
Referral is requested by the individual or parents.
Do not start long-term prophylactic antibiotics in primary care.
Advice
There is evidence that pneumococcal vaccination offers only minimal benefit for the prevention of episodes of acute otitis media (AOM). However,
as pneumococcal vaccination is part of the routine childhood immunization schedule in the UK, it is reasonable to recommend catch up in children,
if this is feasible.
Other advice is recommended on the basis of evidence from mainly observational studies included in a systematic review of modifiable risk factors
for recurrent AOM in childhood [Lubianca Neto et al, 2006] and, in the case of avoidance of flat, supine feeding, from a US national guideline
[American Academy of Pediatrics, 2004].
Referral
People with craniofacial syndromes are generally excluded from trials. Referral is recommended on the basis of expert textbook opinion that they
are at high risk of recurrent AOM and are less likely to spontaneously improve with age [Shah, 2003].
North American guidelines also advise referral to an ear, nose, and throat specialist for ventilation tubes (grommets) for people with recurrent AOM
(defined as three or more episodes in 6 months, or four or more episodes in 12 months) in whom conservative measures have been ineffective
[University of Michigan Health System, 2007; Alberta Medical Association, 2008].
There is limited evidence from a systematic review of two small randomized controlled trials (n = 148) that grommets (ventilation tubes), in
children younger than 3 years of age with recurrent AOM, reduce the number of episodes of AOM and increase the likelihood of being free of
any episodes for 6 months after surgery.
The benefits need to be balanced against the possibility of adverse effects or complications of surgery.
The effects of grommets on recurrent AOM are unknown beyond 6 months (by which time they have often fallen out) or in adults and children
3 years of age and older. Furthermore, both trials included some children with otitis media with effusion (OME): it is possible that grommets are
effective in reducing the frequency of AOM episodes in children with OME, but not those without OME.
CKS recommends referring at the request of parents.
Evidence for adults is not available and has been extrapolated from that for children.
Do not start long-term antibiotics in primary care
There is evidence that long-term antibiotics reduce the risk of any further episodes of AOM while the person is taking them, as well as the number
of episodes. However, they are not recommended for use in primary care because of the increased risk of adverse effects, the cost and
inconvenience, and the possible harms to both the individual and the wider community from antibiotic resistance. They may be considered by a
specialist.
Two of three recent guidelines that comment on this issue agree that long-term prophylactic antibiotics should not be used [University of
Michigan Health System, 2007; Alberta Medical Association, 2008].
The use of long-term antibiotics is advocated in one US guideline [ICSI, 2008] and by several CKS expert reviewers.
Scenario: Persistent acute otitis media - treatment failure
All ages
Management
What should I do if an episode fails to improve or worsens?
Reassess:
Confirm the diagnosis of acute otitis media.
Exclude other causes of middle ear inflammation and acute complications (such as meningitis, mastoiditis, or facial paralysis).
Consider whether referral or admission is necessary.
Confirm adherence to any prescribed antibiotic regimen.
If the person has not been taking an antibiotic (either because it was not prescribed or because of poor adherence):
Prescribe a 5-day course of amoxicillin 40 mg/kg/day in divided doses, that is 13.3 mg/kg three times a day (maximum 1 g three times a day).
This most closely equates to double-dose amoxicillin when prescribed by age, see Prescriptions.
For people who are allergic to penicillin, prescribe a 5-day course of clarithromycin or erythromycin.
If the person has been taking an antibiotic:
Prescribe a 5-day course of co-amoxiclav 40/10 mg/kg/day in divided doses, that is 13.3/3.3 mg/kg three times a day (maximum 1 g three times a
day).
This most closely equates to double-dose co-amoxiclav when prescribed by age, see Prescriptions.
For people who are allergic to penicillin, prescribe a 3-day course of azithromycin 10 mg/kg once a day (maximum 500 mg once a day).
Advise the person or parent to re-consult if the condition worsens or persists despite antibiotics.
If symptoms persist despite two courses of antibiotics, reassess (as above) and seek specialist ear, nose, and throat (ENT) advice.
Tympanocentesis may be required to identify antibiotic-resistant bacteria and guide further treatment.
If the person has multiple antibiotic allergies or intolerance, seek specialist advice.
Reassessment
Recommendations regarding reassessment are based on a National Institute for Health and Care Excellence (NICE) guideline, Prescribing of
antibiotics for self-limiting respiratory tract infections in adults and children in primary care [NICE, 2008a], and guidelines from the American
Academy of Pediatrics and the American Academy of Family Physicians [American Academy of Pediatrics, 2004] and the Alberta Medical
Association [Alberta Medical Association, 2008] on the diagnosis and management of acute otitis media (AOM).
Use of antibiotics
In the absence of recommendations from NICE [NICE, 2008a] or of trial evidence comparing antibiotics with placebo or no treatment in people with
persistent symptoms of AOM (either despite antibiotics or after a period of watchful waiting), recommendations about the management of persistent
AOM are based on expert opinion expressed in North American clinical guidelines [American Academy of Pediatrics, 2004; University of Michigan
Health System, 2007; Alberta Medical Association, 2008; ICSI, 2008].
Choice of antibiotic
Recommendations on the choice of antibiotic are based on Management of infection guidance for primary care for consultation and local
adaptation from the Health Protection Agency (HPA) and the Association of Medical Microbiologists [HPA and Association of Medical
Microbiologists, 2008].
Amoxicillin is effective against the likely bacterial pathogens involved in AOM (Streptococcus pneumoniae, Haemophilus influenzae, Moraxella
catarrhalis).
Erythromycin and clarithromycin (macrolides) are recommended only for people unable to take penicillin as they are less effective against H.
influenzae. Macrolides concentrate intracellularly, but H. influenzae is an extracellular pathogen.
Clarithromycin is generally better tolerated than erythromycin and is more convenient (taken twice daily not four times daily) [DTB, 1991].
The cost difference for tablets is marginal if antibiotics are rarely used. Clarithromycin suspension is more expensive than erythromycin
suspension.
Co-amoxiclav and azithromycin should be reserved for people who have not responded to a first-line antibiotic. Broad spectrum antibiotics (such
as co-amoxiclav) should be avoided when narrow spectrum antibiotics are likely to be effective as they increase the risk of Clostridium difficile
and meticillin-resistant Staphylococcus aureus (MRSA). Azithromycin is not recommended as a first-line antibiotic because it has a long half-life
which increases the risk of developing antibiotic resistance.
Dose of antibiotic
Amoxicillin 40 mg/kg/day (13.3 mg/kg three times a day) is recommended by the British National Formulary for the treatment of otitis media in
children [BNF 57, 2009].
This is an off-label dose of amoxicillin. A variety of doses have been used in clinical trials of otitis media, but 4050 mg/kg/day has been used
fairly consistently in recent times [Rodriguez et al, 1990; Johnson et al, 1991; Principi and Marchisio, 1991; Mohs et al, 1993; Murph et al, 1993;
Pukander et al, 1993; Scholz and Noack, 1998; Damoiseaux et al, 2000; Guggenbichler et al, 2000; Garrison et al, 2004]. CKS was unable to
identify a systematic review that evaluated doses of antibiotics in otitis media.
Higher doses (8090 mg/kg/day) have been used in some clinical trials in an effort to overcome resistance to Streptococcus pneumoniae
[Piglansky et al, 2003; Arguedas et al, 2005; Casellas et al, 2005]. However, this is not thought to be a widespread problem in the UK.
Co-amoxiclav is also recommended at dose of 40 mg/kg/day (13.3 mg three times a day) amoxicillin equivalent.
This is an off-label dose of co-amoxiclav. However, CKS identified 24 trials that used co-amoxiclav 4045 mg/kg/day for otitis media. No
systematic review was identified that evaluated doses of antibiotics in otitis media.
CKS identified nine trials that used higher doses of amoxicillin (8090 mg/kg/day) in an effort to overcome resistance to Streptococcus
pneumoniae.
Clarithromycin is specifically licensed for use in otitis media at 7.5 mg/kg twice a day [ABPI Medicines Compendium, 2006].
Erythromycin has been studied comparatively rarely [Howie and Ploussard, 1972; Scholz and Noack, 1998], but has traditionally been used at the
licensed dose in the UK.
Azithromycin is specifically licensed for use in otitis media at 10 mg/kg once a day [ABPI Medicines Compendium, 2008].
Duration
The 5-day duration of antibiotic regimens is based on Management of infection guidance for primary care for consultation and local adaptation
from the Health Protection Agency (HPA) and the Association of Medical Microbiologists [HPA and Association of Medical Microbiologists, 2008] and
evidence from a Cochrane systematic review [Kozyrskyj et al, 2000].
Persistent symptoms despite two courses of antibiotics
In the absence of evidence for the management of people with persistent symptoms after two courses of antibiotics, the recommendation to seek
specialist advice is pragmatic. Two North American guidelines recommend urgent specialist assessment (on the basis that tympanocentesis may be
required to identify antibiotic sensitivities) [Alberta Medical Association, 2008; ICSI, 2008], but this is not a view supported by CKS expert reviewers.
Multiple antibiotic allergies or intolerance
The recommendation to seek specialist advice is pragmatic and based on two North American guidelines [Alberta Medical Association, 2008; ICSI,
2008].
Referral or admission
When should I refer or admit people with persistent symptoms?

Admit for immediate specialist assessment:
People with suspected acute complications of acute otitis media (AOM), such as meningitis, mastoiditis, and facial paralysis.
If the person was not admitted at initial presentation, admit:
Children younger than 3 months of age with suspected AOM or a temperature of 38C or more.
Children 36 months of age with a temperature of 39C or more. See the CKS topic on Feverish children - management.
Have a low threshold for admitting children younger than 3 months of age with suspected AOM.
Consider admitting:
People who are systemically very unwell.
People with immune deficiencies who are not responding to antibiotics.
Refer for urgent ear, nose, and throat (ENT) specialist assessment:
People 18 years of age or older with persistent symptoms.
Referral may be needed for:
People whose symptoms persist despite two courses of antibiotics seek specialist advice. Tympanocentesis may be required to identify
antibiotic-resistant bacteria and guide further treatment.
People with discharge from the ear canal (otorrhoea) persisting for 2 weeks see the CKS topic on Otitis media - chronic suppurative.
People with tympanic membrane perforation, without otorrhoea, persisting for 6 weeks.
People with hearing loss in the absence of pain or fever see the CKS topic on Otitis media with effusion.
People with recurrent AOM (three or more episodes of AOM in 6 months, or four or more episodes in a year, with an absence of middle ear
disease between episodes) see Scenario: Recurrent acute otitis media.
Recommendations on admission and referral of people with persistent acute otitis media (AOM) and its complications are mainly derived from National
Institute for Health and Care Excellence (NICE) guidelines [National Collaborating Centre for Women's and Children's Health, 2007; NICE, 2008a], a
Scottish Intercollegiate Guideline Network (SIGN) guideline [SIGN, 2003], and North American guidelines [University of Michigan Health System, 2007;
Alberta Medical Association, 2008; ICSI, 2008], or are pragmatic advice.
Admission
The recommendation to admit people with acute complications of AOM is pragmatic and based on guidelines from the Scottish Intercollegiate
Guidelines Network (SIGN) and the US Institute for Clinical Systems Improvement [SIGN, 2003; ICSI, 2008].
The recommendations to admit children younger than 3 months of age with a temperature of 38C or more, and children 36 months of age with a
temperature of 39C or more is based on the NICE guideline, Feverish illness in children Assessment and initial management in children
younger than 5 years [National Collaborating Centre for Women's and Children's Health, 2007]. See the CKS topic on Feverish children -
management.
Evidence on the most appropriate management of children younger than 3 months of age with suspected AOM is limited or conflicting. The NICE
guideline, Prescribing of antibiotics for self-limiting respiratory tract infections in adults and children in primary care, excludes children younger than
3 months of age in its scope [NICE, 2008a]. A low threshold for admission is recommended on the basis of expert opinion expressed in North
American guidelines [University of Michigan Health System, 2007; Alberta Medical Association, 2008] and a textbook [Barnett, 2003] that AOM may
be associated with bacteraemia, meningitis, or other systemic illness in these children.
However, in a study of 67 infants admitted to an Israeli hospital and diagnosed with AOM, none were subsequently found to have meningitis or
bacteraemia [Sakran et al, 2006].
The recommendation to consider admitting people who are systemically very unwell is pragmatic, and implied by the NICE guideline, Prescribing of
antibiotics for self-limiting respiratory tract infections in adults and children in primary care [NICE, 2008a].
The recommendation to consider admitting people with immune deficiencies who are not responding to antibiotics is based on North American
guidelines [British Columbia Medical Association, 2004; Alberta Medical Association, 2008; ICSI, 2008].
Urgent referral
The recommendations to refer adults with persistent symptoms is based on advice in a US guideline to refer adults with persistent AOM to rule out
a serious underlying cause such as nasopharyngeal cancer [University of Michigan Health System, 2007].
Persistent symptoms despite two courses of antibiotics
In the absence of evidence for the management of people with persistent symptoms after two courses of antibiotics, the recommendation to seek
specialist advice is pragmatic. Two North American guidelines recommend urgent specialist assessment (on the basis that tympanocentesis may be
required to identify antibiotic sensitivities) [Alberta Medical Association, 2008; ICSI, 2008], but this is not a view supported by CKS expert reviewers.
Other
The recommendation to refer people with otorrhoea that persists for 2 weeks is made on the basis that these people may nave chronic suppurative
otitis media (see the CKS topic on Otitis media - chronic suppurative), and on the basis of comments from CKS expert reviewers.
The recommendation to refer people with a dry perforation at 6 weeks is based on a Canadian regional guideline [British Columbia Medical
Association, 2004]. The Scottish Intercollegiate Guideline Network (SIGN) also recommends referral but does not specify a time period [SIGN,
2003].
Evidence
Supporting evidence
There is a lack of evidence on the management of acute otitis media in adults and children younger than 6 months of age. Where recommendations
apply to these groups, they are often made by extrapolation from the evidence base for children 6 months of age or older.
Diagnosing acute otitis media
Evidence on diagnosing acute otitis media
Limited evidence from a systematic review suggests that the most accurate individual symptoms and signs for diagnosing acute otitis
media (AOM) are ear pain, ear rubbing, a cloudy or distinctly red or bulging tympanic membrane, or a distinctly immobile tympanic
membrane (on pneumatic otoscopy). Fever, upper respiratory tract symptoms, crying, restless sleep, and irritability are individually
less useful, but no studies have assessed the accuracy of several symptoms and signs combined. These findings are limited by bias
in the studies included in the review.
A systematic review of the precision and accuracy of symptoms and signs for the diagnosis of AOM included six studies [Rothman et al, 2003].
One study looked at precision of diagnoses among junior paediatric doctors in the USA.
Agreement between junior doctors and correlation with diagnoses of otolaryngologists was fair.
Four studies looked at the accuracy of symptoms (n = 965) and one study investigated the accuracy of signs (n = 2911).
Ear pain and ear rubbing were found to be useful for diagnosing AOM, reflected in statistically significant positive likelihood ratios. However,
neither had a significant negative likelihood ratio for a diagnosis of AOM.
A cloudy tympanic membrane, a 'distinctly' red (haemorrhagic, strongly red, or moderately red) tympanic membrane, and a bulging tympanic
membrane were the most accurate individual signs for diagnosing AOM (reflected in statistically significant positive and negative likelihood
ratios). A distinctly immobile tympanic membrane was also a very accurate sign, but this requires pneumatic otoscopy, which is not routinely
performed in UK primary care.
Fever, upper respiratory tract symptoms, crying, restless sleep, and irritability were individually less useful, but no studies have assessed the
accuracy of several symptoms and signs combined.
Study limitations included: lack of blinding (five studies); use of clinical diagnosis, rather than tympanocentesis, as the gold standard (four
studies); and lack of generalizability to primary care (two studies).
Antibiotics for non-recurrent acute otitis media

Evidence on antibiotics for non-recurrent acute otitis media
Antibiotics for pain and fever
Evidence on antibiotics compared with placebo for pain and fever
In children with acute otitis media (AOM), antibiotics significantly reduce pain and fever at 27 days compared with placebo. However,
this benefit is marginal (15 children need to be treated to prevent one child suffering pain on days 27) and needs to be balanced
against the increased risk of adverse effects and the development of antibiotic resistance.
A Cochrane systematic review (updated March 2003) of eight studies including 2287 children with AOM, from 6 months to 15 years of age and
without tympanostomy tubes, found that the benefits of antibiotics were marginal [Sanders et al, 2004].
The risk of pain on days 27 was 15.6% in the treatment group and 22.2% in the placebo group (pooled relative risk [RR] 0.70, 95% CI 0.60 to
0.81, p < 0.001). The number needed to treat (NNT) was 15 (95% CI 11 to 24).
In the three studies that were based in general practice, the benefits of antibiotics were smaller; two reported non-significant results.
The duration of symptoms prior to study entry was not stated for most of the studies included in the review. Children whose symptoms have
been present for 0.52 days will have a different prognosis to those whose symptoms had already lasted 37 days.
Pain in the first 24 hours was not significantly reduced by antibiotics compared with placebo (pooled RR 1.02, 95% CI 0.85 to 1.12, p = 0.91).
Only four studies reported adverse effects: children who took antibiotics had a significantly increased risk of vomiting, diarrhoea, or rash
compared with those who took placebo (17% compared with 11%; pooled RR 1.60, 95% CI 1.19 to 2.16, p = 0.002).
There were no significant differences in the risk of hearing problems at 1 month or of developing contralateral otitis media (three studies).
A subsequent double-blind randomized, controlled trial compared amoxicillin with placebo for 10 days, in 532 children from 6 months to
5 years of age with AOM (of whom 19 children were subsequently excluded) [Le Saux et al, 2005].
Methods:
The children were closely followed up and parents in both groups were offered an additional prescription for an antibiotic if symptoms either
did not improve or worsened during the study period.
The primary outcome was accepting a subsequent antibiotic prescription (other than the amoxicillin intervention); secondary outcomes were
presence of pain, fever, and lethargy after 3 days, recurrence rate after 1 month, and the presence of middle-ear effusion after 3 months.
Children also received, as required, ibuprofen for 5 days and codeine for 2 days.
Results:
Using intention-to-treat (ITT) analysis, 80% of children receiving placebo had clinical resolution after 14 days (20% subsequently received a
prescription for antibiotics) compared with 90% receiving amoxicillin (10% subsequently received a prescription for another antibiotic).
Statistical significance is not stated, but the difference was significant when ITT was not used.
The average number of children needed to treat to prevent one failure within 14 days was 11 (95% CI 6.83 to 30).
Two-thirds of children in the placebo group who eventually received an antibiotic used it in the first 3 days.
Overall, more children in the placebo group had pain and fever in the first 2 days compared with those receiving amoxicillin.
There were no significant differences between the groups in terms of middle-ear effusion or adverse effects.
Limitations:
The use of subsequent antibiotic prescribing as a proxy for treatment failure may be inappropriate: quality of life outcomes may be more
appropriate [Sanders et al, 2004].
Antibiotics for prevention of complications
Evidence on antibiotics for the prevention of serious complications
Serious complications following acute otitis media (AOM) are rare in the UK. It is estimated that nearly 5000 children with otitis media
would need to be treated to prevent one episode of mastoiditis. Although mastoiditis a serious disease, most children make an
uncomplicated recovery with treatment. This marginal benefit is likely to be outweighed by the possibility of future treatment failure
due to antibiotic resistance. There is very little evidence on the effectiveness of antibiotics to prevent meningitis, although, out of
nearly 5000 children treated with a delayed antibiotic prescribing strategy, no child subsequently developed meningitis.
As serious complications are rare, they are seldom seen in randomized, placebo-controlled trials (RCTs) of antibiotics for AOM. Even when the
results of RCTs are combined in systematic reviews, there are still too few people with serious complications to accurately estimate any effect of
antibiotics in preventing them. Consequently, the results of large observational studies have been considered.
Evidence from RCTs
One systematic review did not report on serious complications [Rosenfeld et al, 1994].
One systematic review stated that 'in children not initially treated with antibiotics for AOM, about 1 in 1000 developed mastoiditis' [Takata et al,
2001].
One systematic review that compared antibiotics with placebo reported one case of mastoiditis in a penicillin-treated group [Sanders et al, 2004].
This would equate to a rate of about 1 in 2000 for both groups combined.
Evidence from observational studies
A retrospective cohort study investigated the incidence of mastoiditis and its relationship to preceding otitis media and use of antibiotics in
children between 3 months and 15 years of age between 1990 and 2006 [Thompson et al, 2009]. The children were registered with one of
423 general practices that make up the UK GP Research Database.
Over a million episodes of otitis media were identified in almost half a million children.
Mastoiditis affected 1.2 children per 10,000 years of follow up.
Out of a total of 854 children with mastoiditis, only a third had visited their GP and been diagnosed with otitis media in the preceding 3 months
(half of whom had received antibiotics).
The incidence of mastoiditis remained stable throughout the study period despite a halving in antibiotic prescribing for AOM (p < 0.01). However,
the incidence of otitis media diagnoses also decreased by 34% (p < 0.01).
Antibiotics halved the risk of developing mastoiditis after an episode of otitis media.
After adjusting for gender, age, type of otitis media, and number of episodes of otitis media in the preceding 3 months, the risk of developing
mastoiditis within 3 months of an episode of AOM was 1.8 per 10,000 episodes in children treated with antibiotics, compared with
3.8 per 10,000 episodes for untreated children.
The risk difference was 2.0 per 10,000 episodes (95% CI 1.4 to 2.8).
Nearly 5000 children would need to be treated with antibiotics for otitis media to prevent one episode of mastoiditis.
The main limitations of the study were the possibility of misclassification, and differences in unrecorded prognostic factors between treated and
untreated children, such as severity of otitis media (resulting in confounding).
The authors concluded that, although mastoiditis is a serious disease, most children make an uncomplicated recovery after treatment and the
very small benefits of antibiotics are outweighed by the possibility of future treatment failure owing to antibiotic resistance.
In a large Dutch study, no children developed meningitis and only one child developed mastoiditis out of almost 5000 children from 212 years of
age with otitis media treated with a 72-hour 'wait and see' policy before prescribing antibiotics [van Buchem et al, 1985]. The child with mastoiditis
made a full recovery.
The National Institute for Health and Care Excellence (NICE) guideline, Prescribing of antibiotics for self-limiting respiratory tract infections
in adults and children in primary care, calculated, based on Hospital Episode Statistics (20067), that mastoiditis is rare in the UK. It affects
1.4 people per 10,000 inhabitants per year [NICE, 2008a].
A retrospective study of acute complications of otitis media in adults estimated that the age-adjusted incidence of acute intratemporal and
intracranial complications of otitis media in Finland is 3.2 per 10,000 inhabitants per year, of which almost 80% are acute mastoiditis and just 8%
are meningitis [Leskinen and Jero, 2005].
Of adults with acute mastoiditis, 85% had preceding AOM (as opposed to chronic otitis media). All of the adults with meningitis had preceding
AOM.
All of the adults with acute complications due to AOM had been treated with antibiotics.
Permanent hearing loss occurred in 26% of adults with acute complications. Death occurred in one out of four adults with meningitis.
A narrative review [Froom et al, 1997] reported a case-controlled study [Kilpi et al, 1991] finding similar rates of positive blood cultures in
children with bacterial meningitis who had been treated with antibiotics in the previous week (for any reason) as those who had not. This is however
very weak evidence in support of a no antibiotic prescribing strategy.
Immediate compared with delayed or no prescription
Evidence on immediate compared with delayed or no prescription for antibiotics
When compared with an immediate antibiotic prescribing strategy, a delayed (or 'watchful waiting') prescribing strategy for acute otitis
media (AOM) reduces the consumption of antibiotics, the intention to consult a doctor for future episodes, and the likelihood of
adverse effects (mainly diarrhoea), without appearing to increase the long-term risk of mastoiditis, recurrent earache, or hearing
problems. This is at the expense of a delay in recovery by an average of 1 day, increased analgesic requirements, and (at most) a
small reduction in parental satisfaction with treatment.
The National Institute for Health and Care Excellence (NICE) performed a systematic review [NICE, 2008a] and identified two other systematic reviews
on the effectiveness of delayed antibiotic prescribing and/or no prescribing as strategies for managing respiratory tract infections, compared with an
immediate antibiotic prescribing strategy [Arroll et al, 2003; Spurling et al, 2007]. Between them, these systematic reviews included three trials on
people with AOM [Little et al, 2001; McCormick et al, 2005; Spiro et al, 2006], but meta-analysis was not performed. CKS found one subsequent
unblinded, randomized trial comparing immediate antibiotics prescription with no treatment [Neumark et al, 2007]. The primary studies are reviewed
here.
Immediate compared with delayed antibiotic prescribing
An unblinded trial randomized 315 children between 6 months and 10 years of age presenting to 42 GPs in south west England, with AOM (which
had already lasted for, on average, 1.5 days) to an immediate or delayed prescription for antibiotics [Little et al, 2001].
Methods and limitations:
The delayed antibiotic prescribing strategy consisted of instructions to parents to collect a prescription for antibiotics (from the GP surgery
reception) if their child still had substantial earache or fever after 72 hours, or was not starting to get better.
Primary outcome measures were symptom resolution, number of days off nursery or school, and paracetamol use.
Secondary outcome measures were parental satisfaction and attitudes, antibiotic use, and adverse effects.
The antibiotic dose may have been subtherapeutic in 20% of the study population (who were older than 6 years of age). This may have
biased results in favour of the delayed antibiotic prescribing strategy.
Results for primary outcome measures:
On average, symptoms resolved about 1 day earlier in children receiving an immediate prescription compared with a delayed prescription
(p < 0.01).
There was no significant difference detected in the number of days off nursery or school (p = 0.56).
Significantly less paracetamol was used in the immediate prescription group compared with the delayed prescription group (p < 0.01).
Results for secondary outcome measures:
Parents given an immediate prescription for their children were more likely to be very satisfied with the treatment approach than those given a
delayed prescription (91% compared with 77%; p < 0.01) but they were also more likely to consult a doctor for future episodes (83% compared
with 63%; p < 0.01).
Compared with the delayed antibiotic prescribing group, antibiotics were more often used in the immediate antibiotic prescribing group
(132/134 compared with 36/150; it was not reported why results were incomplete). However, of the 36 children in the delayed group given
antibiotics, antibiotics were sought before 72 hours (presumably by urgent consultation) for 29 (81%) of them.
Diarrhoea was more common in the immediate compared with the delayed group (19% compared with 9%; p = 0.02).
The groups were followed up at 3 months and 1 year to determine whether there were any differences in recurrence of earache or in hearing
and speech [Little et al, 2006]. Analysis showed that, compared with an immediate prescribing strategy, a delayed antibiotic prescribing strategy
did not significantly increase the risk of:
Recurrent AOM (earache) after 3 months (odds ratio [OR] 0.89, 95% CI 0.48 to 1.65) or after 1 year (OR 1.16, 95% CI 0.60 to 1.78).
Poor hearing and speech scores at 3 months (OR 1.37, 95% CI 0.72 to 2.60) or after 1 year (OR 1.16, 95% CI 0.61 to 2.23).
These results were not substantially changed after adjusting for subsequent antibiotic use.
The authors acknowledge that caution is needed when interpreting secondary analyses, particularly given that the trial was powered to detect
differences in short-term outcomes.
Another open-label trial randomized 283 children to receive either immediate treatment with antibiotics (chosen by the doctor) or a delayed 'wait
and see' prescription, which was to be redeemed only if symptoms had not improved after 48 hours [Spiro et al, 2006]. All children received oral
ibuprofen and topical anaesthetic drops.
Most prescriptions were not redeemed in the delayed-prescription group (62%), compared with 13% not redeemed in the group who immediately
received a prescription. The main reasons for redeeming a delayed prescription were continued fever or earache.
Earache was more likely to persist in children who received the delayed prescription (average 2.4 days compared with 2.0 days, p = 0.02).
However, children who received antibiotics immediately were more likely to suffer from diarrhoea (23% compared with 8%; p < 0.01).
In the group receiving delayed prescriptions, the presence of fever and earache corresponded with the likelihood of redeeming the
prescription.
There was no difference between groups in the likelihood of making an unscheduled visit for medical advice or treatment after 3040 days.
The authors concluded that the use of a 'wait and see' approach to using antibiotics in AOM was a viable alternative to routine antibiotic
prescribing, and its implementation would reduce the number of antibiotics used.
Immediate- compared with no-antibiotics prescribing strategy
A randomized trial compared immediate antibiotics with no treatment in 223 children with acute otitis media, from 6 months to 12 years of age,
and recruited at a US university paediatric clinic [McCormick et al, 2005].
The no-treatment control group was termed 'watchful waiting'; there was no planned follow up, but parents were 'encouraged to notify research
personnel if symptoms remained more severe after initiation of treatment'.
Assessor blinding was planned but lost in 22% of the immediate antibiotics group and 26% of the 'watchful waiting' group.
Primary outcomes were:
Parental satisfaction.
Resolution of symptoms (reported in a self-completed diary that was examined retrospectively).
Failure of treatment strategy (returning to the clinic with persistent or worsening symptoms on days 012), recurrence (returning on days 12
30), and cure (no failure or recurrence).
Nasopharyngeal carriage of Streptococcus pneumoniae strains resistant to antibiotics.
Results:
Parental satisfaction did not differ between the two groups (p-value not stated).
Symptoms resolved faster in the immediate antibiotics group compared with the 'watchful waiting' group (p = 0.004).
Failure was more common in the 'watchful waiting' group than the immediate antibiotics group (21% compared with 5%; p-value not stated).
However, the results table appears to suggest that recurrence was less frequent in the 'watchful waiting' group; a direct statistical comparison
does not appear to have been performed.
Failure or recurrence was more common in people who had received antibiotics within 30 days before enrolment.
Immediate antibiotics resulted in eradication of S. pneumoniae carriage in most children, but S. pneumoniae strains cultured from children in
the antibiotics groups were more likely to be multidrug resistant than strains from children in the 'watchful waiting' group.
Adverse effects:
There were no serious AOM-related adverse events.
There were no significant differences in antibiotic-related adverse events (p = 0.06), extra consultations, or time off school or work (for
parents), but significantly more doses of analgesia were taken in the 'watchful waiting' group compared with the immediate antibiotics group
(7.7 compared with 3.4; p < 0.01).
An unblinded, randomized trial, published subsequent to the search dates of the systematic reviews, compared treatment with oral
phenoxymethylpenicillin (penicillin V) with no treatment in 179 children with AOM between 2 and 16 years of age [Neumark et al, 2007].
Methods:
Parents or guardians received written information about 'how to act if the condition did not improve or got worse within three days after
randomization', which was presumably to seek medical attention, although this was not clearly stated.
Primary and secondary outcomes were not explicitly stated (and sample size calculations were not performed), but the authors reported on
recovery times, duration and severity of pain, duration of fever, and analgesic use.
Results:
The median recovery time (in the opinion of the child or their parents) was 4 days in both groups.
There was a small but statistically significant difference in the mean number of days with more severe pain: 0.1 in the antibiotic group and 0.5
in the no-treatment group (p < 0.001).
There was no statistically significant difference in the mean number of days with fever on days 17 (p = 0.085).
Children in the no-treatment group used significantly more analgesia compared with those in the antibiotics group (median 1 dose per day
compared with 0 doses; p < 0.001).
Children in the antibiotic group consulted less during the first 7 days (p < 0.001).
There was no significant difference in the rate of middle-ear effusions or perforations after 3 months.
The rate of adverse effects in children taking antibiotics was not reported.
Phenoxymethylpenicillin is not recommended for use to treat AOM in the UK [HPA and Association of Medical Microbiologists, 2008].
Antibiotics for persistent acute otitis media
Evidence on antibiotics for persistent acute otitis media
There is a lack of evidence on the efficacy of antibiotics compared with placebo or no treatment in people with persistent acute otitis
media.
CKS found no randomized controlled trials comparing antibiotics with placebo or no treatment in people with persistent symptoms of acute otitis
media (either despite antibiotics or after a period of watchful waiting).
Antibiotics in certain groups
Evidence on antibiotics in certain groups
Children from 6 months to 2 years of age with bilateral acute otitis media (AOM) and children with both AOM and otorrhoea
(irrespective or age or laterality of disease) benefit most from antibiotics.
There is insufficient evidence to determine if children younger than 6 months of age or adults benefit any more or less from antibiotics than children
older than 6 months of age.
There is also insufficient evidence to determine who is most at risk from serious complications or whether antibiotics are more effective in people who
are unwell.
Children
Evidence on antibiotics in children
Children from 6 months to 2 years of age with bilateral acute otitis media (AOM), and children with AOM who have otorrhoea
(irrespective or age or laterality of disease), benefit most from systemic antibiotics. There is insufficient evidence to determine if
children younger than 6 months of age might benefit more or less from antibiotics than children 6 months of age or older.
A systematic review (search date not stated), which aimed to determine if there are any subgroups of children who might benefit more or less
from systemic antibiotics, included studies of children from 6 months to 12 years of age for which original data could be supplied [Rovers et al,
2006].
Six RCTs were included, and meta-analysis was performed on individual data from 1643 children. Four studies were excluded because the
original data were not supplied.
Results:
Overall, antibiotics significantly reduced pain or fever, or both, at 37 days compared with placebo or no treatment (overall relative risk
[RR] 0.83, 95% CI 0.78 to 0.89; risk difference [absolute risk reduction] 13%, 95% CI 9 to 17; number needed to treat [NNT] 8).
In children younger than 2 years of age with bilateral AOM, 30% of the antibiotics group and 55% of the control group still had pain, fever, or
both at 37 days (RR 0.64, 95% CI 0.62 to 0.80; NNT 4).
In contrast, for children younger than 2 years of age with unilateral AOM, NNT was 20. For children 2 years of age and older with bilateral
AOM, NNT was 9; for children 2 years of age and older with unilateral AOM, NNT was 15.
In children (of all ages) with AOM who had otorrhoea, 24% of the antibiotics group and 60% of the control group still had pain, fever, or both at
37 days (RR 0.52, 95% CI 0.37 to 0.73; NNT 3). For children with AOM who did not have otorrhoea, the NNT was 8.
A previous systematic review (search date: January 1997) specifically addressed the question of whether antibiotics are more effective in
children with AOM who are less than 2 years of age [Damoiseaux et al, 1998]. It identified six RCTs for inclusion, four of which were suitable for
quantitative analysis (n = 868). Only two of the included trials were truly placebo-controlled, and of these one included only data from children with
recurrent AOM, and the other included only children with non-severe episodes.
The antibiotics included in the studies were penicillin derivatives.
There was no difference in clinical improvement in children less than 2 years of age compared with the reference group (odds ratio [OR] 1.31,
95% CI 0.83 to 2.08). Various sensitivity analyses did not alter this result.
The author noted that the included data were not sufficient to draw firm conclusions, and more studies are needed to address this issue.
Two other systematic reviews could not draw any conclusions on whether antibiotics are more effective in particular groups of children [Takata
et al, 2001; Sanders et al, 2004]. Both reviews reported that there was insufficient stratification of patient status to quantify accurately whether
factors such as age or otitis-prone status were likely to affect outcomes.
A systematic review that primarily focused on the duration of courses of antibiotics also performed subgroup analysis on children younger than
2 years of age [Kozyrskyj et al, 2000]. It found that after 30 days there was no difference between children younger than 2 years of age (n = 118)
compared with those older than 2 years of age (n = 235) in terms of antibiotic failure (OR 0.71, 95% CI 0.30 to 1.64).
Recent systematic reviews of antibiotics compared with placebo for AOM excluded children younger than 6 months of age [Sanders
et al, 2004; Rovers et al, 2006].
CKS performed a search for RCTs that included children younger than 6 months of age, and found only two trials. However, neither trial stratified
results by age [Halsted et al, 1968; Howie and Ploussard, 1972].
Adults
Evidence on antibiotics in adults
There is a lack of evidence on the efficacy or harms of antibiotics or on the effectiveness of delayed or no antibiotic prescribing
strategies in adults.
CKS found no useful randomized, placebo-controlled trials of antibiotics in adults and older children, and two observational studies.
One randomized trial (n = 78) specifically investigated the effect of two different antibiotics in adults and older children (10 years of age or older;
around three-quarters were 20 years of age or older) [Rosen et al, 1983]. However, there was no placebo control and outcomes were principally
microbiological as opposed to clinical or related to well-being or quality of life.
In a prospective cohort study, disease characteristics and treatments were documented in 3224 adults and children with AOM recruited by a
network of general practitioners in developed countries [Culpepper et al, 1993].
Subjective recovery by 2 months was reported more frequently in adults who did not receive antibiotics at the initial visit than those who did (92%
compared with 75%; p = 0.002).
These results should be treated with caution as they are likely to be affected by confounding.
A retrospective study of adults treated in a Finnish university hospital for intratemporal and intracranial complications of otitis media over a 15-
year period (1990 to 2004) reported a low risk of complications: age-adjusted annual incidence was 0.32 per 100 000 inhabitants [Leskinen and
Jero, 2005].
Acute mastoiditis was the most common complication, affecting 78% of people with complications.
However, incidence was markedly lower (p < 0.01) in the first 5-year period than the two later 5-year periods.
Acute, as opposed to chronic, otitis media was the cause of severe complications in 80% of people. All were receiving antibiotics before the
complication.
A relevant comorbidity (diabetes mellitus, cardiac insufficiency, or asthma and allergy) was present in around a quarter of people with severe
complications.
The study may have been biased by incomplete ascertainment of cases.
Very unwell or high risk
Evidence on antibiotics in people who are very unwell or at high risk
There is insufficient published evidence to determine if any groups of people are at higher risk of developing complications or
whether antibiotic use would be more effective for people who are very unwell. Recommendations to offer immediate antibiotics (or
immediate admission) to people who appear systemically very unwell or have symptoms and signs suggestive of mastoiditis are
based on expert opinion.
The National Institute for Health and Care Excellence [NICE, 2008a] reviewed the findings of a prospective cohort study [Damoiseaux et al, 2006]
and an analysis of a randomized, controlled trial (RCT) cohort [Little et al, 2006] based in Netherlands and UK primary care, respectively.
However, they determined that three factors precluded the use of evidence from these two studies as the basis for making recommendations:
No mastoiditis studies were identified that met the inclusion criteria for the review.
The outcome measures reported in the included studies (recurrent acute otitis media [AOM] and recurrent episodes of earache) were not
considered to be serious complications of AOM.
One of the studies merited cautious interpretation as it was a secondary analysis of an RCT.
NICE came to a consensus conclusion that immediate antibiotic prescription and/or further appropriate investigation and management should be
offered to adults and children who appear unwell or who have symptoms and signs suggestive of mastoiditis.
Antibiotic duration
Evidence on antibiotic duration
The optimal duration of antibiotic treatment is not known, and there is a wide variation in prescribing practice, with many North
American guidelines advocating relatively long courses of antibiotics (typically 10 days). However, although it is difficult to compare
different types of antibiotics, the available evidence from randomized controlled trials (RCTs) suggests that, for most children, a
shorter (typically 5-day) course of a penicillin-based antibiotic is sufficient.
A Cochrane systematic review (last search date: March 1998) identified a total of 32 trials suitable for inclusion [Kozyrskyj et al, 2000]. The
primary outcome was treatment failure, which included a lack of clinical resolution, or relapse or recurrence within a month after starting treatment.
The secondary outcome was the number of treatment failures, relapses, or recurrences reported from up to 3 months after the time of diagnosis.
Antibiotics given for less than 48 hours were less effective than antibiotics given for a week or more (OR 2.99, 95% CI 1.04 to 8.54). This
result is difficult to interpret, because only two RCTs were used in the meta-analysis (n = 118). One trial used a 2-day course of penicillin, and
another trial that used amoxicillin as a single dose was stopped early. However, neither regimen can be recommended.
Antibiotics given for 5 days compared with antibiotics given for 810 days were slightly less effective in the short term (primary outcome)
but equally effective in the longer term (secondary outcome), according to data derived from 12 RCTs (n = 3118).
Primary outcome: clinical failure within a month was more likely in the short-course antibiotic group (OR 1.38, 95% CI 1.15 to 1.66). In general,
short courses of antibiotics were less effective at earlier time points.
After 819 days the odds of failure were nearly 50% higher with short-course antibiotics (OR 1.52, 95% CI 1.17 to 1.98).
There was no significant difference between short and long antibiotic regimens in the children who were studied at 2030 days (OR 1.22, 95%
CI 0.98 to 1.54).
In the short term, 11 children would have to receive a longer course of antibiotics compared with a shorter course, to avoid one child
experiencing clinical failure (NNT 11).
Secondary outcomes (treatment failures, relapses, or recurrences up to 3 months) were similar in both regimens (OR 1.16, 95% CI 0.9 to 1.5).
Adverse effects were similar for short or long courses of antibiotics (OR 1.13, 95% CI 0.81 to 1.57).
The review also investigated short courses of long-acting antibiotics (that is azithromycin and ceftriaxone), and found no difference
compared with traditional antibiotics, except that they caused fewer adverse effects.
The authors concluded that '5 days of short-acting antibiotics is an effective treatment for uncomplicated ear infections in children'.
Antibiotics for recurrent acute otitis media
Evidence on antibiotics for recurrent acute otitis media
Antibiotics for acute episodes
Evidence on antibiotics for acute episodes
There is a lack of evidence on the efficacy of antibiotics compared with placebo for episodes of acute otitis media (AOM) in people
with recurrent AOM, or on the prognosis of untreated AOM in people with recurrent AOM. There is moderate evidence that
azithromycin, co-amoxiclav, and newer fluoroquinolones are similar in efficacy when used as first-line antibiotics for AOM episodes in
children with recurrent AOM. There is a lack of evidence of efficacy for older, narrower-spectrum antibiotics (such as amoxicillin) for
episodes of AOM in children with recurrent AOM.
Antibiotics compared with placebo
CKS found no randomized, placebo-controlled trials or studies of the prognosis of untreated AOM in people with recurrent AOM.
In a long-term follow up of cohorts from randomized, controlled trials (RCTs) of immediate- compared with delayed antibiotic prescribing
strategies, secondary analysis was performed on children with recurrent AOM (n = 43), defined as two or more previous episodes of AOM
(identified by extraction of information from medical records) [Little et al, 2006]. In this group:
Fewer episodes of earache were reported (in a questionnaire to parents) in the 3 months following study entry for children who received
immediate antibiotics compared with a delayed prescription (10% compared with 39%; p = 0.029).
There was a similar but non-significant effect for parental rating of poor functioning at 3 months (20% compared to 44%; p = 0.10).
Compared with a delayed prescription, immediate treatment with antibiotics did not affect the risk of poor functioning at 1 year (30% and 32%) or
episodes of earache reported following study entry at 1 year (47% and 52%).
When the National Institute for Health and Care Excellence (NICE) considered the results of this study, they concluded that people with recurrent
AOM should usually be offered a delayed or no antibiotic prescribing strategy, on the basis that NICE did not consider that recurrence of
earache and poor functioning at 3 months (but not at 1 year) were serious complications, and because of the use of secondary analysis [NICE,
2008a].
Choice of first-line antibiotic
CKS found no randomized trials comparing traditional first-line antibiotics (amoxicillin, ampicillin, penicillin, or sulfamethoxazole-trimethoprim) with
newer, broader spectrum antibiotics, but identified one cohort study. CKS identified four randomized trials comparing different newer, broad spectrum
antibiotics.
A retrospective cohort study in children with recurrent otitis media (defined as two episodes of AOM at least 90 days apart) after previous
treatment failure (within the preceding 45 days) found no difference in the need for additional antibiotics within the next 45 days between children
who received traditional first-line antibiotics and those who received broader spectrum, more expensive, second-line antibiotics [Hueston et al,
1999].
These results need to be treated with caution as it is likely that they are biased by confounding variables such as severity of the AOM episode.
A double-blind randomized trial comparing high-dose azithromycin with high-dose co-amoxiclav in 300 children with either recurrent AOM (at
least one episode in the previous 30 days, three episodes in 6 months, or four episodes in 1 year) or persistent AOM (presence of signs and
symptoms of AOM after at least 48 hours of treatment with a single course of a standard oral agent other than study drugs) found no difference in
outcome for children with recurrent AOM [Arrieta et al, 2003].
The main outcome measure was clinical success at day 2830.
Eighty-one percent of the children had a history of recurrent AOM.
For all children, clinical success rates at day 1216 for azithromycin and co-amoxiclav were comparable (86% compared with 84%, respectively).
At day 2832, clinical success rates for azithromycin were superior to those for co-amoxiclav for all children (72% compared with 61%,
respectively; p = 0.047).
However, in children with a history of recurrent AOM, clinical success rates for azithromycin and co-amoxiclav at day 1216 were 87% and 87%,
respectively (p = 1.000; 95% CI of the difference 9.3 to 9.5). Clinical success rates at day 2832 were more favourable for azithromycin, but this
difference did not reach statistical significance (72% and 60%, respectively; p = 0.099; 95% CI of the difference 1.7 to 24.7).
An evaluator-blinded, non-inferiority, randomized trial compared levofloxacin (10 mg/kg twice daily) with low dose co-amoxiclav (amoxicillin
45 mg/kg twice daily) for 10 days in 1305 children (1650 children were randomized) with recurrent and/or persistent acute otitis media [Noel et al,
2008].
Most children (75%) had recurrent AOM, which was defined as three or more episodes of AOM in the 6 months before enrolment, or four or more
episodes over the year before enrolment.
Persistent AOM was defined as evidence of AOM that was unchanged or worsened after 3 days or more of treatment with antibiotics.
A small percentage (13%) had both recurrent and persistent AOM.
For the main outcome measure of clinical cure (resolution of signs and symptoms associated with AOM) 25 days after completing therapy, there
was no significant difference between the groups: 72.4% in the levofloxacin group and 69.9% in the co-amoxiclav group (difference 2.5%; 95%
CI 2.5 to +7.4).
No results were presented for children with only recurrent AOM.
Potential biases were a moderate loss to follow up of 21% and that analysis did not appear to be on an intention-to-treat basis.
Two randomized trials in children with recurrent or persistent AOM found similar efficacy between co-amoxiclav and gatifloxacin (a
fluoroquinolone) [Saez-Llorens et al, 2005; Sher et al, 2005]; however, gatifloxacin is not available in the UK [BNF 57, 2009].
A narrative review reported on the findings of non-comparative studies of newer cephalosporins for AOM episodes in recurrent AOM [Arrieta and
Singh, 2004].
Initial success rates for ceftriaxone and 1- or 3-day courses of cefprozil were between 70% and 94%.
Long-term antibiotics for prevention
Evidence on long-term antibiotics for prevention
In children with recurrent acute otitis media (AOM), long-term antibiotics are efficacious in reducing both the risk of any further
episodes of AOM and the number of episodes whilst receiving treatment. However, this must be balanced against the increased risk
of adverse effects from antibiotics, the cost and inconvenience, and the possible harms to the individual and the wider community
from antibiotic resistance. There is insufficient evidence to recommend a preferred choice of long-term antibiotics.
A Cochrane systematic review (search date: March 2006) of antibiotics for the prevention of acute and chronic otitis media in children identified
sixteen studies (n = 1483) that met the selection criteria [Leach and Morris, 2006].
Randomized, controlled trials (RCTs) of long-term (longer than 6 weeks) antibiotics compared with placebo or no treatment for the prevention of
AOM, AOM with perforation, or chronic suppurative otitis media in children 018 years of age at increased risk of future episodes of AOM, were
included.
The majority of studies were of high quality. Antibiotics were generally given once or twice daily for 36 months.
Subgroup analysis in children with recurrent AOM showed that:
Long-term antibiotics reduced the risk of any episode of AOM by just over a quarter (seven studies, 636 children, relative risk [RR] 0.72,
95% CI 0.62 to 0.84; fixed effect model). There was low-to-moderate statistical heterogeneity (I2 = 33%).
Long-term antibiotics reduced the number of episodes of AOM by a half (eight studies, 796 children, incidence rate ratio 0.52, 95% CI 0.37 to
0.73; random-effects model). The studies were statistically heterogeneous (I2 = 73%).
Results of meta-analyses of all the studies:
Long-term antibiotics reduced the risk of any episode of AOM by around a third (13 studies, 1358 children, RR 0.62, 95% CI 0.52 to 0.75;
random-effects model). There was moderate statistical heterogeneity between the studies (I2 = 52%).
Approximately five children would need to be treated long term to prevent one child experiencing AOM whilst receiving treatment.
Long-term antibiotics reduced the number of episodes of AOM by a half, from around 3 per year to around 1.5 per year (12 studies,
1112 children, incidence rate ratio 0.48, 95% CI 0.37 to 0.62; random-effects model). The studies were statistically heterogeneous (I2 = 65%).
Antibiotics prevented 1.5 episodes of AOM for every 12 months of treatment per child.
Long-term antibiotics were associated with a non-significant increase in adverse events compared with placebo (11 studies, 714 children,
RR 1.99, 95% CI 0.25 to 15.89; random-effects model).
Only two studies reported carriage of resistant respiratory bacteria: 31 of 101 (31%) of the antibiotic group and 18 of 80 (23%) of the control
group carried beta-lactamase resistant Haemophilus influenzae or Moraxella catarrhalis, or both, at 34 months after study entry (RR 1.53,
95% CI 0.78 to 3.00).
The authors concluded that antibiotics reduce both the risk of any further episodes of AOM and the number of AOM episodes whilst receiving
treatment for children at risk, but that this must be balanced against the increased risk of adverse effects, the cost and inconvenience, and the
possibility of increased antibiotic resistance.
A previous systematic review (search date: April 1993) identified nine RCTs (n = 958) that were suitable for inclusion in a meta-analysis that
compared antibiotics for the prevention of recurrent AOM with no treatment or placebo [Williams et al, 1993]. All of these studies were included in
the subsequent Cochrane systematic review. Three of the studies in the Cochrane systematic review were not included in this review. One was
excluded because of 'insufficient specificity regarding the outcomes under study'. The other two were not identified.
Treatment courses lasted between 10 weeks and 2 years, and study quality was considered generally poor. The primary outcome was the rate
of recurrence of AOM.
The pooled rate difference in recurrence of AOM was 0.11 episodes per month favouring the antibiotic group (95% CI 0.03 to 0.19).
No single antibiotic was found to be significantly superior to another. In addition, the authors noted that there was no evidence on how long an
antibiotic should be used for prophylaxis.
The review did not report on the frequency of adverse effects.
Analgesics and antipyretics
Evidence on analgesics and antipyretics for acute otitis media
Both paracetamol and ibuprofen are efficacious for relieving pain in children with acute otitis media (AOM). Both drugs have good
safety profiles and few adverse effects when used at recommended doses. There is very limited evidence that topical analgesics can
provide additional pain relief to oral analgesics in children with AOM, but there are no available, licensed preparations in the UK.
Paracetamol and ibuprofen
A randomized, controlled trial (RCT) compared the efficacy of ibuprofen, paracetamol, or placebo in 219 children with AOM [Bertin et al, 1996].
Outcomes were the appearance of the tympanic membrane, pain relief, rectal temperature, and quality-of-life scores as evaluated by the parents.
All the children also received the antibiotic, cefaclor.
Neither analgesic had an observable effect on inflammatory features of the tympanic membrane.
There were no significant differences in temperature reduction or quality-of-life measurements between the groups.
For pain relief, ibuprofen was reported as being superior to paracetamol, which in turn was reported as being superior to placebo. However,
there were methodological problems in the analysis of these results, and when they were recalculated, ibuprofen was not found to be superior to
paracetamol in terms of pain relief [SIGN, 2003].
See the CKS topic on Feverish children - management for a summary of the evidence on analgesics and antipyretics for fever from any cause in
children.
Topical analgesics
A Cochrane systematic review (search date: May 2006) identified four RCTs that investigated the use of topical analgesics for pain relief in
children with AOM [Foxlee et al, 2006]. Only one small trial (n = 54) compared a topical anaesthetic with placebo; the other trials compared
anaesthetic drops with naturopathic remedies.
The authors concluded that there was insufficient evidence to know whether topical analgesics are effective for AOM.
A subsequent double-blind RCT compared pain relief using topical lidocaine (lignocaine) ear drops or identical placebo in 63 children from 3
17 years of age attending an emergency department (in Australia) with earache and AOM [Bolt, 2008].
The primary outcome was a 50% reduction in pain score from the baseline, which was measured at 10 minutes, 20 minutes, and 30 minutes after
administration using validated pain scales.
Oral analgesia had been used in the previous 4 hours in 77% of the lidocaine group and 75% of the placebo group. Oral paracetamol was also
offered during and after the study period.
Antibiotic use was at the discretion of the treating physician.
Statistically significant differences in the primary outcome measure favouring lidocaine were seen at 10 minutes and 30 minutes, but not
20 minutes. A 50% reduction in pain score was achieved:
At 10 minutes, in 52% of children using lidocaine ear drops and 25% using placebo (relative risk [RR] = 2.06, 95% CI 1.03 to 4.11, p = 0.03).
At 20 minutes, in 68% of children using lidocaine and 50% using placebo (RR 1.35, 95% CI 0.88 to 2.06, p = 0.15).
At 30 minutes, in 90% of children using lidocaine and 63% using placebo (RR 1.44, 95% CI 1.07 to 1.93, p = 0.009).
Methodological limitations:
Whilst analgesia use prior to the study was similar, 23% of children using lidocaine took oral analgesia during the study compared with 13% of
children using placebo. This difference was not controlled for and could have confounded the results.
It was reported that antibiotics were taken in 38% of children in the study by 1 week, but it is not clear how soon antibiotics were commenced
or if there were any differences between the two groups.
Parental or child satisfaction with treatment was not assessed.
Immunizations for prevention
Evidence on immunizations for prevention of acute otitis media
There is evidence that pneumococcal vaccination alone offers minimal benefit for the prevention of episodes of acute otitis media
(AOM). No benefit has been shown from influenza vaccination in the prevention of AOM episodes.
Pneumococcal vaccination
Pneumococcal vaccination has been part of the UK childhood immunization schedule since September 2006 (see www.dh.gov.uk) [CMO et al, 2006].
The purpose of routinely offering pneumococcal vaccine is to reduce the incidence of pneumococcal meningitis as opposed to AOM. See the CKS
topic on Immunizations - pneumococcal.
A Cochrane systematic review (search date: June 2003) investigated the use of pneumococcal vaccine in preventing otitis media [Straetemans
et al, 2004]. In the included trials, 814-valent polysaccharide vaccine and 79-valent pneumococcal conjugate vaccines were used. It was
concluded that the effects of pneumococcal vaccine in preventing recurrent episodes of AOM are minimal.
The pooled rate ratio (eight studies) after adjustment for age and study for reduction in AOM episodes was 0.90 (95% CI 0.81 to 1.00).
The highest efficacy was found in children 2 years of age or older (rate ratio 0.78, 95% CI 0.63 to 0.97).
Pooled results for infants vaccinated as early as 2 months of age, and toddlers attending daycare with recurrent AOM, showed only a small
effect on prevention of AOM (rate ratio 0.92, 95% CI 0.89 to 0.95).
Pneumococcal vaccine had little effect on the prevention of otitis media in children without documentation of prior episodes of AOM.
There was only a moderate effect in the group of children with documented episodes of prior AOM.
Irrespective of age, to prevent one child having one episode of AOM in a year, approximately 32 children would need to be vaccinated.
To prevent one child under 2 years of age having one episode of AOM in a year, approximately 57 children would need to be vaccinated.
In a subsequent randomized, controlled trial, 74 Belgian children, from 17 years of age, with at least two episodes of AOM in the previous
year were immunized with either a 7-valent pneumococcal conjugate vaccine followed by a 23-valent pneumococcal polysaccharide booster or a
control hepatitis A vaccine [van Kempen et al, 2006].
Over a period of 26 months, no reduction of AOM episodes was observed in the pneumococcal vaccine group compared with the control group
(rate ratio 1.16, 95% CI 0.69 to 1.96).
One further trial (sponsored by industry) randomized 4968 healthy infants, recruited from paediatric clinics in the Czech Republic, to a novel
vaccine against both Streptococcus pneumoniae and non-typable Haemophilus influenzae, or to a hepatitis A vaccine placebo [Prymula et al,
2006].
Compared with the placebo vaccine, the active intervention reduced the overall incidence of episodes of AOM by a third (33.6%; 95% CI 20.8 to
44.3).
It may not be possible to generalize these findings to children with recurrent AOM or to the use of other types of pneumococcal vaccines.
A cohort study compared the risk of developing recurrent AOM and the need for grommets (ventilation tubes) in cohorts of children born in
consecutive years during which pneumococcal vaccination was introduced (in two US states) [Poehling et al, 2007].
In both states, there were significant reductions in the risk of recurrent AOM and the need for grommets in one cohort (20002001) in whom 75%
of children were vaccinated compared with a cohort who were not vaccinated. However, reductions were non-significant for another cohort
(20012002) which presumably also had high levels of vaccination.
Influenza vaccination
A large, randomized, double-blind, placebo-controlled trial on 786 healthy children from 612 months of age found no benefit in giving two
doses of inactivated trivalent subvirion influenza vaccine [Hoberman et al, 2003].
Compared with placebo, influenza vaccination did not reduce the proportion of children who had at least one episode of AOM during the
respiratory disease season.
Vaccination did not reduce the monthly rate of AOM, or the estimated proportion of time with a middle-ear effusion or the use of selected
healthcare or related resources.
The study followed children with influenza over two seasons. There was very little influenza activity during the second season. During the season
when there was influenza activity, there were eight episodes of AOM in 273 children who received the vaccine compared with 11 episodes in
138 placebo recipients.
Grommets for recurrent acute otitis media
Evidence on grommets for recurrent acute otitis media
There is limited evidence that, in children younger than 3 years of age with recurrent acute otitis media (AOM), grommets (ventilation
tubes) reduce the number of episodes of AOM and increase the likelihood of being free of any episodes for 6 months after surgery.
These benefits need to be balanced against the possibility of adverse effects and complications of surgery. The effects of grommets
on recurrent AOM are unknown beyond 6 months (by which time they have often fallen out), or in adults and children of 3 years of age
and older.
A Cochrane systematic review (search date: March 2008) of grommets (ventilation tubes) for recurrent AOM in children identified just two
randomized, controlled trials (RCTs) that met its inclusion criteria [McDonald et al, 2008]. In both RCTs, the children were younger than 3 years of
age.
One RCT, involving 95 children, found that grommet insertion led to a mean reduction of 1.5 episodes of AOM in the first 6 months after
enrolment compared with no treatment (0.7 compared with 2.2; no statistical test performed). A statistically significant increase in the proportion
of children without any episodes of AOM in the 6 month period after enrolment was found for treatment compared with control (46% compared
with 5%; p < 0.001).
Another RCT, involving 68 children (with results for only 53 children), found an increase in the proportion of children with no episodes of AOM in
the 6-month period after enrolment for grommet insertion compared with long-term sulfamethoxasole and trimethoprim, but the result (65%
compared with 45%) was not statistically significant.
Methodological limitations:
Both studies included children who also had otitis media with effusion (OME). The review authors state that children with OME are unlikely to
differ fundamentally from children who do not have OME. However, a CKS expert reviewer disagrees, stating: 'As most AOM (is) due to
ascending infection from the Eustachian tube, it is not clear how grommet insertion can reduce the infection unless there is persistent middle
ear effusion.'
Interventions in children with grommets
Evidence on interventions for acute otitis media in children with grommets
There is insufficient evidence for any strong recommendations on the most effective treatment of acute otitis media (AOM) in people
with grommets (ventilation or tympanostomy tubes). One small, randomized, placebo-controlled trial found that co-amoxiclav was
efficacious in reducing the duration of discharge in children. Two trials found topical fluoroquinolones to be superior to oral
antibiotics, but the trials have been limited by high rates of loss to follow up. Furthermore, topical fluoroquinolones are not routinely
available in the UK for ear infections. The high rate of Pseudomonas organisms detected in one trial suggests that taking a swab for
culture and sensitivity should be considered.
A Cochrane systematic review (search date: February 2005) of interventions for ear discharge associated with grommets identified four
randomized trials (n = 410) that met its inclusion criteria [Vaile et al, 2006].
Three studies failed to find a difference between the intervention and control:
Topical dexamethasone 0.1% solution and topical ciprofloxacin, compared with topical ciprofloxacin alone, in 201 children from 6 months to
12 years of age with acute otitis media of less than or equal to 3 weeks' duration and visible otorrhea [Roland et al, 2003].
Oral prednisolone for 3 days compared with placebo in 70 children with acute discharge (for less than 48 hours) [Ruohola et al, 1999]. All of
the children were also treated with oral co-amoxiclav antibiotic and daily suction.
Otosporin drops (three drops, three times daily) compared with Otomize ear spray (one dose, three times daily) in 60 children and adults
from 225 years of age with otorrhoea attending an ear, nose, and throat department [Strachan et al, 2000].
In a fourth study, oral co-amoxiclav was efficacious in reducing the duration of discharge compared with placebo in 79 children with acute
otorrhoea (less than 48 hours' duration) [Ruohola et al, 2003].
The likelihood of children having discharge after 8 days was significantly less if they were receiving co-amoxiclav (odds ratio 0.19, 95% CI 0.07
to 0.49).
For every five children receiving co-amoxiclav, two would have a good outcome (number needed to treat 2.5).
However, all of the children received daily ear washes, which may have modified the effect and may not always be feasible in primary care.
The authors concluded that, with the available data, it was not possible to identify the most effective and safe treatment for ear discharge in
children with grommets. Before offering treatment, any benefit should be balanced against the possible risks of adverse effects and antibiotic
resistance.
A subsequent narrative literature review of acute otitis media in children with grommets concluded that topical fluoroquinolones offer the most
effective treatment, and that topical aminoglycosides should not be used because of the potential for rare ototoxicity [Schmelzle et al, 2008].
This conclusion was based partly on the findings of a randomized trial which reported similar clinical cures rates for topical ofloxacin and co-
amoxiclav, and more favourable microbiological eradication and adverse effect profile for topical treatment. However, this trial was excluded from
the Cochrane systematic review of interventions for ear discharge associated with grommets [Vaile et al, 2006] because of an exclusion rate of
40%, mainly due to the detection of Pseudomonas organisms.
In another randomized, single-blind trial in 80 children from 6 months to 12 years of age with AOM with visible otorrhoea through grommets
of 3 weeks' duration or less, the median time to cessation of otorrhoea was 4 days for topical ciprofloxacin/dexamethasone compared with 7 days
for oral amoxicillin/clavulanic acid (p = 0.0006) [Dohar et al, 2006]. A quarter of children were excluded from the analysis, although this was done
on an intention-to-treat basis.
A subsequent randomized, open-label trial compared topical treatment (a combination of hydrocortisone, oxytetracycline, and polymyxine B)
together with irrigation with and without oral antibiotics (amoxicillin with or without clavulanic acid) for 50 episodes of otorrhoea in children with
recurrent AOM and grommets [Granath et al, 2008]. Although no statistically significant difference was found between the groups, the findings are
limited by the lack of blinding, the lack of a power calculation, and the variability of the oral antibiotic intervention.
Search strategy
Scope of search
A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of acute otitis
media, with additional searches in the following areas:
antibiotic treatment for children under 6 months (searched from 1950-)
antibiotic treatment for recurrent otitis media
clinical features of mastoiditis
pneumococcal vaccination for the prevention of recurrent otitis media
management of otitis media in children with grommets
Search dates
Guidelines, Medline, Embase: January 2006 January 2009
Key search terms
Various combinations of searches were carried out. The terms listed below are the core search terms that were used for Medline.
otitis media/, otitis media.tw
exp anti-infective agents/, antibiotic$.tw
exp infant/, infant$.tw
recurrence/, recurrent.tw
mastoiditis/, mastoiditis.tw
pneumococcal vaccines/, streptococcus pneumoniae/, pneumococcal.tw, pneumococcus.tw, streptococcus pneumoniae.tw, pcv.tw
middle ear ventilation/, tympanostomy tubes.tw, grommet$.tw, ventilation tubes.tw
Table 1 . Key to search terms.
Search commands Explanation
/ indicates a MeSH subject heading with all subheadings selected
.tw indicates a search for a term in the title or abstract

exp indicates that the MeSH subject heading was exploded to include the
narrower, more specific terms beneath it in the MeSH tree
indicates that the search term was truncated (e.g. wart$ searches for
$
wart and warts)
Sources of guidelines
National Institute for Health and Care Excellence (NICE)
Scottish Intercollegiate Guidelines Network (SIGN)
National Guidelines Clearinghouse
New Zealand Guidelines Group
British Columbia Medical Association
Canadian Medical Association
Institute for Clinical Systems Improvement
Guidelines International Network
National Library of Guidelines
National Health and Medical Research Council (Australia)
Royal Australian College of General Practitioners
Alberta Medical Association
University of Michigan Medical School
Michigan Quality Improvement Consortium
Royal College of Nursing
Singapore Ministry of Health
Health Protection Agency
National Resource for Infection Control
CREST
World Health Organization
NHS Scotland National Patient Pathways
Agency for Healthcare Research and Quality
TRIP database
Patient UK Guideline links
UK Ambulance Service Clinical Practice Guidelines
RefHELP NHS Lothian Referral Guidelines
Medline (with guideline filter)

Sources of systematic reviews and meta-analyses
The Cochrane Library :
Systematic reviews
Protocols
Database of Abstracts of Reviews of Effects
Medline (with systematic review filter)
EMBASE (with systematic review filter)
Sources of health technology assessments and economic appraisals
NIHR Health Technology Assessment programme
NHS Economic Evaluations
Health Technology Assessments
Canadian Agency for Drugs and Technologies in Health
International Network of Agencies for Health Technology Assessment
Sources of randomized controlled trials
Central Register of Controlled Trials
Medline (with randomized controlled trial filter)
EMBASE (with randomized controlled trial filter)
Sources of evidence based reviews and evidence summaries
Bandolier
Drug & Therapeutics Bulletin
MeReC
NPCi
DynaMed
TRIP database
Central Services Agency COMPASS Therapeutic Notes
Sources of national policy
Department of Health
Health Management Information Consortium (HMIC)
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Otitis Media - Acute - NICE CKS

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NICE Pathways

Otitis media - acute

Otitis media - acute - Summary

Acute otitis media is infection of the middle ear.

Pain and fever can be managed with paracetamol or ibuprofen.

Children younger than 3 months.

Children who are systemically unwell.

Young children with infection in both ears.

Children with perforation and/or discharge in the ear canal.

If an antibiotic is required, a 5-day course of amoxicillin is recommended.

Children younger than 3 months of age with a temperature of 38C or more.

Children 36 months of age with a temperature of 39C or more.

Avoiding exposure to passive smoking.

Not feeding the child while lying flat.

Have I got the right topic?

How up-to-date is this topic?

Last revised in July 2009

All children younger than 6 months of age.

Children younger than 3 months of age with a temperature of 38C or higher.

Children 36 months of age with a temperature of 39C or higher.

June 2007 update. Amoxicillin prescription corrected. Issued in June 2007.

October 2005 minor technical update. Issued in November 2005.

June 1999 reviewed.

April 1998 reviewed.

January 1997 written.

Guidelines published since the last revision of this topic:

HTAs (Health Technology Assessments)

No new HTAs since 1 February 2009.

No new economic appraisals relevant to England since 1 February 2009.

Systematic reviews and meta-analyses

Systematic reviews published since the last revision of this topic:

Observational studies published since the last revision of this topic:

No new national policies or guidelines since 1 February 2009.

New safety alerts

No new safety alerts since 1 February 2009.

Changes in product availability

No changes in product availability since 1 February 2009.

Goals and outcome measures

Making an accurate diagnosis

Appropriate admission or referral to secondary care

QIPP Options for local implementation

Non-steroidal anti-inflammatory drugs (NSAIDs)

Antibiotic prescribing especially quinolones and cephalosporins

What causes it?

What are the risk factors?

Acute otitis media (AOM) most commonly affects younger children.

Peak incidence is between 6 and 15 months of age [Sanders et al, 2004].

Daycare (nursery) attendance.

Use of formula milk (rather than breast milk).

Craniofacial syndromes (such as Down's syndrome and cleft palate).

Early age of first episode of AOM, particularly before 6 months of age.

Dummy (pacifier) use.

Daycare (nursery) attendance.

Flat, supine feeding.

AOM episode lasting for more than 10 days.

History of not having been breastfed for at least 3 months.

What is the prognosis?

After an initial episode of acute otitis media (AOM):

What are the complications?

Diagnosis of acute otitis media

How do I make a diagnosis of acute otitis media?

Diagnose acute otitis media if there is:

Acute onset of symptoms, including:

In older children and adults earache.