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Original Contribution
Department of Anesthesia, Surgery Division, Pediatric Anesthesia Unit, Federal University of So Paulo, So Paulo, Brazil
Pain Management Service, Cancer Institute of the State of Sao Paulo, So Paulo, Brazil
c
Department of Anesthesia and Pain Management, Santa Paula Hospital, So Paulo, Brazil
d
Department of Anesthesia, University Hospital, University of So Paulo, So Paulo, Brazil
e
Department of Anesthesia, Hospital das Clinicas from the University of So Paulo, So Paulo, Brazil
b
Keywords:
Infiltration anesthesia;
Tramadol;
Intravenous administration;
Postoperative pain;
Hernioplasty
Abstract
Study Objective: The purpose of this trial was to assess if tramadol wound infiltration is superior to
intravenous (IV) tramadol after minor surgical procedures in children because tramadol seems to have
local anestheticlike effect.
Design: Randomized double-blind controlled trial.
Setting: Postanesthesia care unit.
Patients: Forty children, American Society of Anesthesiologists physical status I or II, scheduled to
elective inguinal hernia repair.
Interventions: Children were randomly distributed in 1 of 2 groups: IV tramadol (group 1) or
subcutaneous infiltration with tramadol (group 2). At the end of the surgery, group 1 received 2 mg/kg
tramadol (3 mL) by IV route and 3-mL saline into the surgical wound; group 2 received 2 mg/kg
tramadol (3 mL) into the surgical wound and 3-mL saline by IV route.
Measurements: In the postanesthesia care unit, patients were evaluated for pain intensity, nausea and
vomiting, time to first rescue medication, and total rescue morphine and dipyrone consumption.
Main Results: Pain scores measured during the postanesthesia recovery time were similar between
groups. Time to first rescue medication was shorter, but not statistically significant in the IV group.
The total dose of rescue morphine and dipyrone was also similar between groups.
63
Conclusions: We concluded that tramadol was effective in reducing postoperative pain in children, and
there was no difference in pain intensity, nausea and vomiting, or somnolence regarding IV route or
wound infiltration.
2016 Elsevier Inc. All rights reserved.
1. Introduction
It is well recognized that optimal postoperative pain
management is essential for children and that analgesia
should be started even before the surgery. Standardized
approaches for postoperative nausea and vomiting and pain
control are both important factors to be optimized in
outpatient children undergoing minor surgical procedures.
Preventive multimodal analgesia, which comprises a combination of different drugs and regional anesthesia techniques, can offer the advantage of high-quality pain relief [1]
and reduced amount of opioid consumption in the perioperative period [2]. Local anesthetics administered either by
neuraxial techniques, peripheral nerve blocks, or local
infiltration are adopted as adjuvants to general anesthesia
and are associated to excellent pain control, rapid recovery
from anesthesia, and fewer opioid side effects [3].
Tramadol has been demonstrated to have local analgesic
effect in previous studies in adults [4,5] and children [6-9].
Besides being a weak synthetic opioid, tramadol inhibits the
reuptake of monoaminergic neurotransmitters (5-hydroxytryptamine and noradrenaline) and has a local anesthetic
like action on peripheral nerves [10] similar to lidocaine 1%
[11]. The addition of tramadol to local anesthetics in peripheral
nerve block prolongs the duration of the analgesia [12,13]
and has an analgesic effect similar to levobupivacaine when
injected subcutaneously [4].
The objective of this study was to evaluate if wound
infiltration with tramadol confers additional beneficial
results in terms of postoperative pain control of children
submitted to minor pediatric surgeries.
64
the study. Basal values of heart rate (HR), systolic blood
pressure, diastolic blood pressure, mean arterial pressure,
end-tidal carbon dioxide, and peripheral oxygen saturation
were recorded just before induction and at each 5-minute
interval till the end of the surgery.
At the end of the procedure, anesthesia was discontinued,
Laringeal Mask Airway was removed, and the patient was
left to recover in the postanesthesia care unit (PACU).
Pain was evaluated using 2 different scales in the PACU.
Six-point Wong Baker Faces Pain Rating Scale (WBFPRS)
(0 = no hurt; 1 = hurts little bit; 2 = hurts little more; 3 = hurts
even more; 4 = hurts whole lot; 5 = hurts worst) and Simple
Descriptive Scale (SDS) (0 = no pain; 1 = mild pain; 2 =
moderate pain; 3 = severe pain). Pain at rest was evaluated
soon after awake from anesthesia, then at 10, 20, 60, and 120
minutes after the end of the surgery.
When pain was scored greater than 4 by the WBFPRS,
moderate by SDS, or continuous crying persisted longer than
5 minutes, a first IV dipyrone bolus dose (30 mg/kg) was
administered by an anesthesiologist blinded to the study
intervention. If pain persisted for more than 10 minutes after
first IV dipyrone administration, morphine (0.1 mg/kg) was
provided, and the time to first rescue medication was noted.
After establishment of oral feeding, patients were
discharged from the hospital, and parents were oriented to
contact the researcher in case of uncontrolled pain, nausea, or
vomiting. Medical appointment was scheduled 1 week later.
2.1. Outcomes
The primary outcome was pain intensity assessed
according to pain scores, time to first analgesic rescue
administration, total dose of rescue dipyrone (in milligrams
per kilogram), and total dose of rescue morphine (in
milligrams per kilogram) for the first 120 minutes after the
end of the procedure. Side effects such as nausea, vomiting,
and sedation were considered as secondary outcomes.
Sedation was assessed by a Ramsay Scale and was
considered at least mild when patients scored 4 or higher (1 =
patient awake and anxious, agitated, or restless; 2 = patient
awake and cooperative, oriented and calm; 3 = patient asleep,
responsive to commands.; 4 = patient asleep, with brisk
response to stimuli [light and noise]; 5 = patient asleep, with
response only to pain; 6 = patient with no response to any
stimuli [light, noise, or pain]).
Postoperative pain and common side effects were
assessed by an anesthesiologist trained in pediatric anesthesia
and pain management.
Nausea and vomiting were registered according to their
occurrence during PACU stay before discharge to the ward.
3. Results
A total of 40 patients were enrolled in the study. Two
patients in group I were excluded due to venous line
extravasation, 1 was excluded for inadequate nerve block
and 1 patient in group II was excluded due to intravenous
line extravasation. Overall data from 37 patients19 in
group I (IV tramadol) and 18 in group II (tramadol wound
infiltration)were analyzed.
There was no difference in age, weight, surgery duration,
ASA physical status, and total amount of fentanyl consumption during anesthesia between the 2 groups (Table 1). Both
groups were similar comparing MAP and HR, both in
operating room and in PACU (data not shown).
Pain scores measured by WBFPRS and SDS were similar
between groups. Time to first rescue medication was shorter
in group 1 (IV group), but it did not reach statistical
significance (Table 2; P = .77). The total dose of rescue
morphine and dipyrone was also similar between groups (P =
.35) (Table 2).
There were no statistically differences in side effects such
as nausea, vomiting, and sedation between groups (Fisher
exact test; Table 3).
4. Discussion
Pain is a highly individualized and subjective event,
influenced by cultural and emotional aspects. Because
assessment of pain is difficult in clinical practice, anesthesia
planning should begin with preoperative assessment of
anxiety of parents and children. A multimodal and
preventive analgesia approach, in which nonopioid analgesics, such as nonsteroidal anti-inflammatory drugs and local
anesthetics are combined with opioids, is recommended to
maximize pain control and minimize drug-induced adverse
side effects [14].
The optimal analgesic strategy for pediatric inguinal
hernia repair remains undefined. Available evidence comparing caudal blockade to alternative analgesic strategies in
achieving postoperative analgesia is still controversial [15].
However, the addition of an ultrasound-guided ilioinguinal
nerve block to a single-shot caudal block is efficient to
decrease pain scores in inguinal hernia repair patients [16].
65
Group II,
mean (SD)
or prevalence
Female/male (%)
0.59
0.61
Age (mo)
57.15 (30.28) 70.66 (28.72)
Weight (kg)
20.18 (5.51) 23.81 (9.32)
ASA
I
0.85
0.95
II
0.15
0.05
Surgery duration (min) 34.21 (14.10) 33.33 (15.22)
Total fentanyl (g/kg)
0.12 (0.40)
0.12 (0.25)
1
.3863
.2675
.60
.891
.4631
Table 2
Main outcomes.
Outcome
Group I Group II P*
(median) (median)
WBFPRS
5 min
10 min
20 min
60 min
120 min
Simple descriptive pain scale
5 min
10 min
20 min
60 min
120 min
Total dose (mg/kg) of rescue drug,
mean (DP)
Morphine
Dipyrone
Time to first analgesic demand
(min), mean (DP)
1.5
3
0
0
0
2
1
1
0
0
.9037
.2278
.4582
.609
.3126
2
2
0
0
0
1
1.5
0
0
0
.6971
.8379
.4315
.132
.2899
0.041
(0.04)
22
(17.52)
63.0
(17.20)
0.054
(0.06)
21.5
(15.72)
70.6
(32.8)
.683
.9141
.7705
Table 3
Secondary outcomes.
Outcome
Group I
(prevalence)
Group II
(prevalence)
Nausea
Vomiting
Somnolence
0.05
0.05
0.42
0.11
0.11
0.33
.6039
1
.7374
66
This factor has to be taken into consideration when we
investigate the local effect of tramadol. In addition,
subcutaneous absorption is conditioned to the ionization
constant of tramadol solution, which may be affected by the
dilution of the drug in different concentrations, which may
interfere with the parent drug systemic absorption.
The last consideration to be made is the ilioinguinal nerve
blockade before surgical incision with 1% lidocaine. Blood
concentrations of local anesthetics in young children after
ilioinguinal block can be twice those measured in older
children [16], which would make local anesthesia duration
extremely variable in the studied population [27]. However,
it has been reported that IINB could provide analgesia for 60
to 120 minutes [19,20]. As a result, local analgesic effect of
tramadol could not be exclusively demonstrated in the
present research. On the other hand, for both groups
(intravenous or subcutaneous), predicted longer pharmacokinetic profile of tramadol may have overcome the effect of
the IINB provided by lidocaine itself.
In our opinion, the major obstacles of this study are the
limitation of young children to self-report pain, the lack of a
placebo group, and the peripheral nerve blockade before
surgical incision. We chose not to change the anesthesia
protocol but prioritize children comfort. Further studies
concerning local effect of drugs should use patient controlled
analgesia as an analgesic titration method and separate
children younger than 4 years old from older ones, to get a
more effective feedback of pain evaluation.
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Acknowledgments
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