Tramadol en Niños
Tramadol en Niños
Tramadol en Niños
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.
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.
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
relevant and that the SD of WBFPRS based on a pilot study
in our institution was 0.8, to achieve a power of 95% with a type I
error rate of 0.05 for the Student t test, 17 patients per study group
were necessary. So, we included 20 patients in each group.
To assess the null hypothesis, Fisher exact test or
Wilcoxon-Mann-Whitney for ordinal data tests using R
software (R Foundation for statistical computing, Vienna,
Austria) were used.
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].
T1
T2
T3
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
[8]
[9]
[10]
[11]
[12]
[13]
[14]
[15]
[16]
[17]
Acknowledgments
[18]
[19]
[20]
References
[1] Lnnqvist P-A. Blocks for pain management in children undergoing
ambulatory surgery. Curr Opin Anaesthesiol 2011;24:627-32.
[2] Ecoffey C. Safety in pediatric regional anesthesia. Paediatr Anaesth
2012;22:25-30.
[3] Boretsky KR. Regional anaesthesia in paediatrics: marching forward.
Curr Opin Anaesthesiol 2014;27:556-60.
[4] Demiraran Y, Albayrak M, Yorulmaz IS, Ozdemir I. Tramadol and
levobupivacaine wound infiltration at cesarean delivery for postoperative
analgesia. J Anesth 2013;27:175-9.
[5] Ozyilmaz K, Ayoglu H, Okyay RD, Yurtlu S, Koksal B, Hanci V, et al.
Postoperative analgesic effects of wound infiltration with tramadol and
levobupivacaine in lumbar disk surgeries. J Neurosurg Anesthesiol
2012;24:331-5.
[6] Karg E, Ikdemir A, Tokgz H, Erol B, Iikdemir F, Hanci V, et al.
Comparison of local anesthetic effects of tramadol with prilocaine
during circumcision procedure. Urology 2010;75:672-5.
[7] Heiba MH, Atef A, Mosleh M, Mohamed R, El-Hamamsy M.
Comparison of peritonsillar infiltration of tramadol and lidocaine for
[21]
[22]
[23]
[24]
[25]
[26]
[27]