Parecoxib sodium reduces the need for opioids after tonsillectomy in children: a double-blind placebo-controlled randomized clinical trial

Abstract

Objective: Postoperative pain is a common phenomenon after pediatric tonsillectomy. This prospective randomized double-blind placebo-controlled clinical trial was performed to evaluate the analgesic efficacy of intravenous parecoxib sodium in children undergoing tonsillectomy. Methods: Sixty children (American Society of Anesthesiologists physical status I-III, aged three to seven years, and scheduled to undergo elective tonsillectomy under general anesthesia) were randomly allocated into one of two groups to receive intravenous parecoxib sodium 1 mg·kg−1 (Group P, n = 30) or the same volume of saline (Group S, n = 30) just after induction of general anesthesia. Between-group comparisons were made for the number of patients requiring rescue morphine, total number of doses of postoperative rescue morphine, time to first rescue analgesic, postoperative pain and sedation scores, and adverse effects. Results: Rescue morphine was given to more children in Group S (25/30, 83%) than in Group P (17/30, 57%) [relative risk (RR), 1.5; 95% confidence interval (CI), 1.0 to 2.1; P = 0.024]. The mean (SD) time to first rescue analgesic was shorter in Group S than in Group P [132 (54) min vs 193 (78) min, respectively; mean difference, 61; 95% CI, 26.6 to 96.1; P = 0.001]. The median (interquartile range [IQR]) Children’s Hospital of Eastern Ontario Pain Scale scores in the postanesthesia care unit were lower in Group P than in Group S (7 [5-8] vs 9 [8-11], respectively; P = 0.001). The incidence of postoperative nausea and vomiting (PONV) was higher in Group S than in Group P [11/30 (37%) vs 4/30 (13%), respectively; RR, 2.8; 95% CI, 1.0 to 7.7; P = 0.037]. Conclusions: A single intravenous injection of parecoxib sodium 1 mg·kg−1 after anesthesia induction is an effective method for the control of postoperative pain. It provides a morphine-sparing effect, prolongs the time to first rescue analgesic, and reduces PONV in children undergoing tonsillectomy.