Research

Original Investigation

Complications of Ventilation Tube Insertion in Children

With and Without Cleft Palate
A Nested Case-Control Comparison
Ian Smillie, MRCS Ed; Sophie Robertson; Anna Yule; David M. Wynne, FRCS; Craig J. H. Russell, FRCS

IMPORTANCE Optimizing hearing in patients with cleft lip and/or palate (CLP) by early
recognition and management of otitis media with effusion is essential for speech
development. Some evidence has suggested higher complication rates from ventilation tube
(VT) insertion in patients with CLP and has led to a trend not to treat these patients surgically.
However, studies have failed to match comparison groups for age and sex.

OBJECTIVE To compare complication rates from VT insertion in pediatric patients with and
without CLP.

DESIGN, SETTING, AND PARTICIPANTS The study used a nested case-control design to evaluate
60 pediatric patients with CLP who underwent VT insertion at a childrens hospital. The
control group of age- and sex-matched patients was selected from a database of 2943 VT
insertions.

INTERVENTIONS All patients were administered general anesthesia and underwent VT

insertion by a pediatric otorhinolaryngology (ENT) team.

MAIN OUTCOMES AND MEASURES The primary outcomes were numbers of otorrhea
complications. Secondarily, rates of attendance at an ENT clinic specifically for complications
were evaluated. Finally, numbers of complications other than otorrhea were assessed but not
statistically analyzed owing to the varied types and low numbers in each group.

RESULTS The control cohort had 151 documented cases of otorrhea compared with 121 in the
CLP group (ratio 1.25:1); the difference between groups was not statistically significant
(P = .52). There was no significant difference in mean ENT clinic visits per patient for
complications between groups (0.80 in the CLP group, 0.78 for controls) (P = .66). Regarding
complications other than otorrhea, the control group reported more than the CLP group (43
vs 25; ratio, 1.7:1).

CONCLUSIONS AND RELEVANCE Complication rates of VT placement among patients with CLP
were not higher than those among patients without CLP. Therefore, treatment with VT
insertion should be administered to patients with CLP under the same guidelines as for those
without CLP. Indeed, there could be an argument for a shift in practice toward more
aggressive treatment of patients with CLP, who are already vulnerable to speech and social
developmental delay.
Author Affiliations: Department of
Paediatric OtolaryngologyHead and
Neck Surgery, Royal Hospital for Sick
Children (Yorkhill), Glasgow, Scotland
(Smillie, Robertson, Yule, Wynne);
Department of Plastic Surgery, Royal
Hospital for Sick Children, Glasgow,
Scotland (Russell).
Corresponding Author: Ian Smillie,
MRCS Ed, Department of Paediatric
OtolaryngologyHead and Neck
Surgery, Royal Hospital for Sick
Children (Yorkhill), Dalnair Street,
JAMA Otolaryngol Head Neck Surg. 2014;140(10):940-943. doi:10.1001/jamaoto.2014.1657 Glasgow G3 8SJ, Scotland
Published online August 28, 2014. (iansmillie@nhs.net).

940 jamaotolaryngology.com

Copyright 2014 American Medical Association. All rights reserved.

Downloaded From: http://jamanetwork.com/pdfaccess.ashx?url=/data/journals/otol/930968/ on 06/08/2017

 Complications of Ventilation Tube Insertion
C
left lip and/or palate (CLP), also referred to as orofacial
clefting, is the most common craniofacial anomaly iden-
tified at birth.1 With an incidence of 1 in 700 births, CLP
accounts for 1000 new cases in the United Kingdom annually.2
Orofacial clefts have functional and aesthetic implications
for a child that require intensive multidisciplinary input
to address.
Optimizing hearing in patients with CLP is essential to
avoid problems in speech development in a group already
disadvantaged. This may involve the use of hearing aids or
surgical intervention with ventilation tube (VT) insertion.
Otitis media with effusion (OME) and recurrent acute otitis
media (AOM) are the most common reasons for conductive
hearing loss in children. This hearing impairment is variable
in clinical course but can have detrimental effects on speech
development.3
The cumulative prevalence of both OME and AOM in pe-
diatric patients with CLP is 90% to 100%, with problems de-
veloping at a younger age than in children without CLP.3-7 Cur-
rent literature recommends VT insertion for OME causing
significant conductive deficit for more than 3 months or re-
current AOM totaling more than 4 episodes per year.3,8
Complications associated with VT insertion have been
reported as high as 80%.9 The most apparent complication
reported to cause significant patient morbidity is otorrhea.
Studies have suggested that otorrhea rates are higher in
patients with CLP than in those without.10 In addition, it has
been suggested that speech outcomes are poorer in children
with DLP who receive surgical intervention for middle ear
disease.10-12 This has caused significant controversy over the
optimal management of conductive hearing loss in this group
and ultimately has led to a trend not to insert VTs in patients
with CLP even if they meet the criteria defined in national
guidelines.
However, studies have failed to match control groups for
age and sex. The aim of the present study is to assess if there
is a significant difference in complications from VT insertion
in patients with and without CLP who are matched for age
and sex.
Methods
There is no institutional review board at the Yorkhill Royal Hos-
pital for Sick Children, but all participants or their parents or
guardians provided written informed consent for participa-
tion in this study at the time of surgery.
The study used a nested case-control design that individu-
ally matched children with CLP and those without CLP for age
and sex. Sixty patients with CLP underwent insertion of VTs
between May 2002 and October 2012 at the Royal Hospital for
Sick Children, Glasgow, Scotland. All of these patients also un-
derwent CLP corrective surgery at the same institution.
A control group of children without CLP was selected from
a database of 2943 VT insertions over the same period at RHSC
by matching patients for age and sex. The patients were
matched initially for sex and then for age at the time of VT in-
sertion (all matched control patients were aged within 0.1 years
jamaotolaryngology.com
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jamanetwork.com/pdfaccess.ashx?url=/data/journals/otol/930968/ on 06/08/2017
Original Investigation Research
of their corresponding patient with CLP). Hospital notes were
reviewed for data relating to otorrhea and otorhinolaryngol-
ogy (ENT) clinic attendance (follow-up and complication-
specific visits). In addition complications other than otor-
rhea were noted.
The primary outcome was otorrhea, which was defined as
discharge from the ear (excluding wax), whether clear or mu-
copurulent. There was no subdivision made on possible in-
fective origin because microbiology findings were not avail-
able for most patients. The secondary outcome assessed was
attendance at an ENT clinic for complications, defined as ap-
pointments specifically arranged on an urgent basis for com-
plications and distinct from scheduled CLP follow-up visits.
The 2 outcomes were subject to a Wilcoxon signed rank test
to assess for statistically significant difference between the CLP
and non-CLP groups.
The correlation between age and otorrhea rates was also
assessed using a Spearman rank correlation coefficient. Other
complications documented at ENT clinic visits are reported but
not statistically analyzed.
Results
Sixty patients with CLP underwent VT insertion between May
2002 and October 2012 at the Royal Hospital for Sick Children
Glasgow. The male to female ratio was 1.22:1; median age at the
time of surgery, 3.5 years (age range, 0.6-10.4 years). Patients
were assessed for significant comorbidities, but there were no
exclusions made from either group of patients.
Total complications for patients with CLP were 146, with
a mean of 2.4 complications per patient. In comparison, the
control group had 194 complications, with a mean of 3.2 com-
plications per patient. Figure 1 illustrates the complications in
each study group.
Otorrhea rates were higher in the non-CLP cohort, with 151
documented episodes occurring in the 60 patients compared
to 121 in the study group. The mean number of otorrhea epi-
sodes per patient in the CLP group was 2.0 compared with 2.5
in the non-CLP group. Interestingly, 23 in the CLP group (38%)
and 24 in the non-CLP group (40%) had no otorrhea reported.
There was no significant difference between otorrhea rates in
Figure 1. Otorrhea and Other Complication Rates in Patients
With and Without CLP
250 Otorrhea
Other complications
200
Complications, No.
150
100
50
0
Non-CLP CLP
Illustrated are the numbers of total complications, including otorrhea, occurring
in all study participants. CLP indicates cleft lip and/or palate.
JAMA OtolaryngologyHead & Neck Surgery October 2014 Volume 140, Number 10 941
 Research Original Investigation Complications of Ventilation Tube Insertion

Table. Complications Other Than Otorrhea Reported in Clinic Visits Figure 3. Otorrhea and Other Complication Rates in Patients
With and Without Cleft by Sex
Other Complications CLP Non-CLP
Otalgia 10 17
Otorrhea
Retracted tympanic membrane 3 5
120 Other complications
Tympanic membrane perforation 4 3
Blood in canal 2 5 100

Complications, No.
Grommet occlusionwax 4 1 80

Tinnitus 2 2 60

Tympanosclerosis 0 3 40
Attic crust 0 2 20
Posterior pars tensa cholesteatoma 0 2 0
Non-CLP CLP Non-CLP CLP
Attic retraction 0 1 Male Male Female Female
Granulation tissue 0 1
Edema of ear canal 0 1 Illustrated are the numbers of total complications, including otorrhea, occurring
in all study participants, subdivided by patient sex. CLP indicates cleft lip and/or
Total 25 43
palate.
Abbreviation: CLP, cleft lip and/or palate.

Figure 2. Otorrhea Complications in Patients With and Without CLP signed rank test, P = .66). Mean follow-up for patients with CLP
was 2.95 years, which was longer than the 2.2 years for the non-
8 CLP group.
Otorrhea Complications, Mean No./Patient

CLP
7
Non-CLP
6

5
4 It is essential to maximize hearing in pediatric patients with
3
2 with VT insertion. The high incidence and resolution of OME
1 in children suggests that this is a natural phenomenon, but
0
<1.0 1.0-1.9 2.0-2.9 3.0-3.9
Age, y
Illustrated are the mean numbers of otorrhea complications per patient found in
each age group. CLP indicates cleft lip and/or palate.
the 2 groups (Wilcoxon signed rank test, P = .52). The number
of other reported complications (Table) was higher in the non-
CLP than in the CLP group, with totals of 43 and 25, respec-
tively (ratio, 1.7:1). This was not analyzed for statistical signifi-
cance owing to the varied complications reported and low
numbers in each group.
Otorrhea numbers were higher in children younger than
2 years in both groups. This is illustrated in Figure 2, which
shows the mean otorrhea rates for both the CLP and non-
CLP groups. The highest mean otorrhea rate was in patients
without CLP aged 1 to 1.9 years (7.0 documented cases of
otorrhea per patient). There was a significant negative corre-
lation between increased age and otorrhea rate, (Spearman
= 0.275; P = .02). When we evaluated otorrhea rates by
patient sex, we found no significant differences (P = .79)
(Figure 3).
Patients with CLP had more ENT visits for general review
per patient than did those without CLP (4.6 vs 3.6). However,
we found no significant difference in ENT attendance specifi-
cally for complications (0.80 non-CLP vs 0.78 CLP) (Wilcoxon
Discussion
CLP to avoid delays in speech and social development. This
may involve the use of hearing aids or surgical intervention
some patients are at greater risk of language delays and be-
4.0-4.9 5.0-5.9 6.0 havioral problems.4 This creates controversy over the opti-
mal management of OME in these patients.
Current guidelines in the United Kingdom call for VT in-
sertion in children (1) who have experienced significant con-
ductive hearing loss due to OME for greater than 3 months or
(2) who have had AOM episodes totaling 4 per year or 3 within
6 months.3,8,13 A Cochrane review4 has contradicted this guid-
ance, reporting no significant benefits over the first postop-
erative year, but this study did not assess patients at in-
creased risk of developmental delay such as patients with CLP.
Specific to patients with CLP, higher complication rates and
poorer speech outcomes have been reported after VT treat-
ment for OME vs patients without CLP.10,11 However, most CLP
studies have been widely criticized for their poor design or
small sample size. It is therefore more appropriate to evalu-
ate conclusions on VT insertion from the higher-quality stud-
ies not specific to CLP.
Previous comparative studies comparing children with and
without CLP have suggested higher complication rates in the
CLP group, but the control groups were not matched for age
or sex.12 These comparative studies suggest that there is in-
sufficient evidence on which to base the clinical practice of
early VT placement for OME or AOM in children with CLP. How-
ever, the present study, the first to our knowledge to match
both age and sex, contradicts the previous evidence. We have
demonstrated that there is no statistically significant differ-

942 JAMA OtolaryngologyHead & Neck Surgery October 2014 Volume 140, Number 10 jamaotolaryngology.com

Copyright 2014 American Medical Association. All rights reserved.

Downloaded From: http://jamanetwork.com/pdfaccess.ashx?url=/data/journals/otol/930968/ on 06/08/2017

 Complications of Ventilation Tube Insertion Original Investigation Research

ence between the CLP and non-CLP group for otorrhea or ENT
attendance for complications.
This disparity arises from the effects of patient age and sex
on complications. It is imperative to age match because stud-
ies have shown that younger age at VT insertion is directly
linked to higher complications rates.14 This is a very impor-
tant variable because patients with CLP tend to be diagnosed
and treated for OME or AOM at a younger age. Our results sup-
port this with a finding of negative correlation between in-
creased age and otorrhea. The importance of sex matching has
been demonstrated in previous studies as well, with higher
complication rates reported in boys than in girls.15 Interest-
ingly, our results showed no statistically significant differ-
ence by sex.
Conclusions
To our knowledge, this is the first study to match patients
with CLP and non-CLP controls for both age and sex. Our
findings, therefore, are the best evidence available to mea-
sure the effect of CLP on complication rates. Ultimately, this
study has shown that complications are not higher within
the CLP treatment group, and therefore patients with CLP
should be treated for AOM and OME in the same way as non-
CLP patients. Indeed, there could be an argument for a shift
in practice toward more aggressive treatment in the CLP
group that is already vulnerable to speech and social devel-
opmental delay.

ARTICLE INFORMATION
Submitted for Publication: April 29, 2014; final
revision received July 7, 2014; accepted July 12,
2014.
Published Online: August 28, 2014.
doi:10.1001/jamaoto.2014.1657.
Author Contributions: Dr Smillie had full access to
all of the data in the study and takes responsibility
for the integrity of the data and the accuracy of the
data analysis.
Study concept and design: Robertson, Yule, Wynne,
Russell.
Acquisition, analysis, or interpretation of data:
Smillie, Robertson, Yule, Russell.
Drafting of the manuscript: Smillie, Robertson, Yule.
Critical revision of the manuscript for important
intellectual content: Smillie, Wynne, Russell.
Statistical analysis: Smillie, Robertson, Yule.
Administrative, technical, or material support:
Smillie, Robertson, Yule, Wynne.
Study supervision: Wynne, Russell.
Conflict of Interest Disclosures: None reported.
REFERENCES
1. Goodacre T, Swan MC. Cleft lip and palate:
current management. Paediatr Child Health (Oxford).
2008;18(6):283-292.
2. Gorlin RJ, Cohen MM, Levin LS. Syndromes of the
Head and Neck. 3rd ed. Oxford, England: Oxford
University Press; 1990.
3. National Institute for Health and Care
Excellence. Surgical management of children with
otitis media with effusion (OME): NICE clinical
guidelines. http://www.nice.org.uk/guidance/CG60.
Accessed July 17, 2014.
4. Lous J, Burton MJ, Felding JU, Ovesen T, Rovers
MM, Williamson I. Grommets (ventilation tubes) for
hearing loss associated with otitis media with
effusion in children. Cochrane Database Syst Rev.
2005;25(1):CD001801.
5. Harman NL, Bruce IA, Callery P, et al. MOMENT:
Management of Otitis Media with Effusion in Cleft
Palate: protocol for a systematic review of the
literature and identification of a core outcome set
using a Delphi survey. Trials. 2013;14:70.
6. Sheer FJ, Swarts JD, Ghadiali SN. Finite element
analysis of eustachian tube function in cleft palate
infants based on histological reconstructions. Cleft
Palate Craniofac J. 2010;47(6):600-610.
7. Kwan WM, Abdullah VJ, Liu K, van Hasselt CA,
Tong MC. Otitis media with effusion and hearing
loss in Chinese children with cleft lip and palate.
Cleft Palate Craniofac J. 2011;48(6):684-689.
8. McDonald S, Langton Hewer CD, Nunez DA.
Grommets (ventilation tubes) for recurrent acute
otitis media in children. Cochrane Database Syst Rev.
2008;4(4):CD004741.
9. Vlastarakos PV, Nikolopoulos TP, Korres S,
Tavoulari E, Tzagaroulakis A, Ferekidis E. Grommets
in otitis media with effusion: the most frequent
operation in children: but is it associated with
significant complications? Eur J Pediatr. 2007;166
(5):385-391.
10. Ponduri S, Bradley R, Ellis PE, Brookes ST,
Sandy JR, Ness AR. The management of otitis
media with early routine insertion of grommets in
children with cleft palate: a systematic review. Cleft
Palate Craniofac J. 2009;46(1):30-38.
11. Robson AK, Blanshard JD, Jones K, Albery EH,
Smith IM, Maw AR. A conservative approach to the
management of otitis media with effusion in cleft
palate children. J Laryngol Otol. 1992;106(9):788-792.
12. Khwaja S, Sheehan PZ, Davenport P, Whitby D.
A Comparison of Otorrhoea Rates Post Ventilation
Tube Insertion in Cleft v Noncleft Children. Paper
presented at the 2010 Annual Conference of The
Craniofacial Society of Great Britain and Ireland;
March 25, 2010; Liverpool, England.
13. Scottish Intercollegiate Guidelines Network.
Diagnosis and management of childhood otitis media
in primary care: guideline 66. http://www.sign.ac.uk
/guidelines/fulltext/66/. Accessed July17, 2014.
14. Moller P. Selective use of ventilating tubes in
the treatment of secretory otitis media and
retractions of the eardrum. Acta Otolaryngol. 1982;
94(386):158-160
15. Mandel EM, Swarts JD, Casselbrant ML, et al.
Eustachian tube function as a predictor of the
recurrence of middle ear effusion in children.
Laryngoscope. 2013;123(9):2285-2290.

jamaotolaryngology.com JAMA OtolaryngologyHead & Neck Surgery October 2014 Volume 140, Number 10 943

Copyright 2014 American Medical Association. All rights reserved.

Downloaded From: http://jamanetwork.com/pdfaccess.ashx?url=/data/journals/otol/930968/ on 06/08/2017