A Comparative Study of Tramadol and Clonidine as an Additive to Levobupivacaine in Caudal Block in Pediatric Patients Undergoing Perineal Surgeries.

Abstract

Background:Caudal block is a simple, safe procedure with fewer side effects to provide intraoperative and postoperative analgesia in pediatric patients. Many drugs were used as an additive to local anesthetics in caudal block. All these drugs had their own side effects.Aims:In this study, we compare the effects of tramadol and clonidine as an additive to levobupivacaine in caudal block in children undergoing perineal surgeries regarding hemodynamic changes, analgesic effects, and side effects.Settings and Design:This is a prospective, double-blind randomized, controlled study, conducted in Department of Paediatric Surgery, at King George's Medical University, Lucknow, Uttar Pradesh during 2017–2018.Materials and Methods:After informed consent and ethical clearance from institutional ethics committee, King Georges Medical University, Lucknow. Total 66 patients aged 1–10 year, planned for perineal surgery were randomly allocated according to computer-generated random number, into three groups. Group I - 0.25% levobupivacaine (1 mL.kg-1) alone, Group II - 0.25% levobupivacaine (1 mL.kg-1) with tramadol 1 mL.kg-1, and Group III - 0.25% levobupivacaine (1 mL.kg-1) with clonidine 1 μg.kg-1. Perioperative pain was the primary outcome. Hemodynamic parameters: heart rate, mean arterial pressure, and peripheral oxygen saturation were recorded. Postoperative pain assessed by Children and Infants Postoperative Pain Scale (CHIPPS), sedation by Ramsay sedation score and requirement of rescue analgesia were recorded at predetermined time intervals.Statistical Analysis:The values were represented in number (%) and mean ± standard deviation. Comparison of quantitative variables between the study groups was done using ANOVA test and Mann–Whitney U-test. Categorical data were analyzed using Chi-square test.Results:Postoperative analgesic effect was significantly longer in levobupivacaine with clonidine group as compared to tramadol with levobupivacaine group and levobupivacaine alone group.Conclusion:Clonidine in a dose of 1 μg.kg-1 when added to levobupivacaine in caudal block significantly prolongs the duration of analgesia as compared to tramadol with levobupivacaine and levobupivacaine alone without any clinically significant side effects. Thus, it is better to add additive like clonidine to enhance the effect of analgesia.