Parecoxib sodium reduces the need for opioids after tonsillectomy in children: a double-blind placebo-controlled randomized clinical trial Le parécoxib sodique réduit le besoin d'opioïdes après une amygdalectomie chez l'enfant: une étude clinique randomisée contrôlée par placebo à double insu
AbstractObjective 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 mgÁkg -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 mgÁkg -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.
RésuméObjectif La douleur postopératoire est un phénomène courant après une amygdalectomie pédiatrique. Cette étude clinique prospective randomisée contrô lée par placebo et à double insu a été réalisée afin d'évaluer l'efficacité analgésique du parécoxib sodique intraveineux chez des enfants subissant une amygdalectomie. Méthode Soixante enfants (statut physique I-III selon la classification de l'American Society of Anesthesiologists, âgés de trois à sept ans et devant subir une amygdalectomie non urgente sous anesthésie générale) ont été aléatoirement alloués à l'un de deux groupes. Le groupe P (n = 30) a reçu 1 mgÁkg -1 de parécoxib sodique intraveineux, alors que le groupe S (n = 30) a reçu le même volume de sérum physiologique juste après l'induction de l'anesthésie générale. ...