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INFORMATION:

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A COMPARATIVE STUDY OF CAUDAL BUPIVACAINE AND BUPIVACAINE TRAMADOL FOR ANALGESIA IN PAEDIATRIC INFRAUMBILICAL SURGERIES

ABSTRACT

Background: Caudal analgesia using bupivacaine is commonly used for the relief of pain in

children. Paracetamol and/or non-steroidal anti-inflammatory drugs, commonly oral

ibuprofen, are used for postoperative control of pain, but their analgesic effect is often

insufficient. Opioids on the other hand, administered intravenously, provide effective

analgesia but the fear of their side-effects, especially respiratory depression, emesis and

sedation, have restricted their use. This study evaluated one modality of perioperative

analgesia in children for infra-umbilical surgeries using different drugs, comparing the effect

of addition of caudal tramadol to bupivacaine.

Methodology: This was a prospective, randomized, double-blind study. American Society of

Anesthesiologists (ASA) physical status classes I and II patients were recruited from the

Orthopaedic surgery and Plastic surgery units. The patients were of both sexes, aged between

1 year and 6 years scheduled for elective infra-umbilical surgeries.

Baseline heart rate (HR), non-invasive blood pressure (NIBP), arterial oxygen saturation

(SpO2), respiratory rate (RR), and temperature were measured and recorded. Inhalational

induction using halothane (0.5% increments up to 3%) in 100% oxygen was administered via

a face mask using the Jackson Rees’ modified Ayre’s T piece before intravenous (IV)

cannulation. Venous access was established and IV infusion of lactated Ringers’ solution

mixed with 50% dextrose in water commenced. Aseptic procedure was used in the caudal

administration of preservative-free plain bupivacaine, (National Agency for Food and Drug

Administration and Control (NAFDAC) registration number A4 – 9832) and preservative

free tramadol, NAFDAC approved, ( NAFDAC registration number A4 – 2539) to all the

children using 21-gauge to 23-gauge hypodermic needles. Surgery commenced 15 minutes

after the caudal injection. The patients were randomly assigned to receive 1 ml/kg of 0.25%

bupivacaine (group A) or 1ml/kg of 0.25% bupivacaine plus 1mg/kg of tramadol (group B).

14

Intraoperatively, monitoring of the SpO2, HR, RR, NIBP was recorded every 5 minutes.

Postoperatively, these parameters were recorded every 15 minutes in the first hour and hourly

for another 3 hours. Postoperative pain assessment using Toddler pre-schooler postoperative

pain score (TPPPS), need for additional analgesia and the occurrence of adverse event(s) was

determined and recorded.

Results: One Hundred and Thirty Four patients participated in the study ( A, n = 66 and B,

n = 68). At the point of skin incision, 10 patients (4 in group A, and 6 in group B) recorded

≥15% rise in systolic arterial pressure (SAP) or HR from the baseline values. These patients

were regarded as having had failed caudal block, excluded from the study and their surgeries

concluded under general anaesthesia. The socio-demographic characteristics, ASA status and

duration of surgery were comparable in both groups. The proportion of patients with

significant postoperative TPPPS ≥3 at 3 hours was 20 (32.3%) patients in group A and none

in group B, p = 0.0012. Group B had significant mean duration of analgesia of 10.89 ± 1.10

hours compared with group A of 3.2 ± 1.0 hours, p = 0.0014. The proportion of patients with

incidence of vomiting was 2 (3.23%) in group A which was similar to group B of 3 (4.84%),

p = 0.4702. None of the patients in both groups had motor weakness, urinary retention in the

postoperative period.

Conclusion: The addition of tramadol to bupivacaine for caudal analgesia resulted in longer

analgesia in the postoperative period compared to bupivacaine alone, with acceptable side

effect profile.

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