Analgesic Efficacy of Topical 0.25% Levobupivacaine in the Control of Postoperative Pain in Children After Tonsillectomy: A Double Blind, Prospective, Randomized, Controlled Study

Abstract

Background: Tonsillectomy or adenotonsillectomy have a high incidence of postoperative pain. Topical approaches have the advantage of local pain control with minimal systemic side effects and good patient acceptability. Levobupivacaine may be useful in pediatric practice. We preferred topical levobupivacaine in our study because of the lack of enough data in the literature about its topical use in pediatric tonsillectomy cases for postoperative analgesia. Material & Methods: A double blind prospective randomised controlled clinical trial conducted in 54 children aged between 4 and 12 years, ASA I–II, of both sex, suffering from recurrent tonsillitis, chronic tonsillitis, tonsillo-adenoid syndrome, scheduled for elective tonsillectomy and/or adenotonsillectomy in Department of Anaesthesiology, M B Government Hospital, attached to RNT Medical College, Udaipur, Rajasthan, India. Informed written consent from parents of each patient participating in the study was obtained. Patients were evaluated using behavioural scale (FLACC scale) Face, Legs, Activity, Cry, consolability at the 1st, 4th, 12th, 18th, 24th, 48th hrs, 3rd day, 4th day and 7th day postoperatively. The total number of doses of rescue analgesic required by each patient in the first 48 hrs was noted. Postoperative complications like post-tonsillar bleeding from the operating site was noted and re-explored. A post hoc test was used to assess intergroup differences, P<0.05 was considered as statistically significant. Results: In the present study, the two groups (control versus levobupivacaine group) were statistically comparable regarding mean age, mean weight, sex, mean body weight, ASA grading, diagnoses, surgery performed and the duration from induction to placement of swabs (completion of surgery) which was statistically non-significant (P>0.05) in between groups. Pain scores in Group L v/s Group C at 4th hr were 1.22 ± 0.698 v/s 2.85 ± 2.143; at 12th hr were 1.44 ± 1.188 v/s 4.52 ± 0.935; at 18th hr were 1.30 ± 1.353 v/s 4.33 ± 1.209; at 24th hr were 1.37 ± 1.214 v/s 4.30 ± 1.37; and at 48th hr were 1.11 ± 0.698 v/s 2.89 ± 0.698 respectively(P<0.001). Pain scores were comparable in the rest of the hours and days, P>0.05. The total number of doses of rescue analgesic was significantly higher in Group C (58 doses) as compared to Group C (18 doses), P<0.001. Conclusion: We conclude that topical application of swabs soaked in10 ml of 0.25% levobupivacaine for 5 min after tonsillectomy in the tonsillar bed is a simple and effective approach and therefore be safely recommended as a safe and reliable method of postoperative pain relief after tonsillectomy.