The Effects of Ondansetron on the Analgesic Action of Intravenous Acetaminophen after Tonsillectomy in Children: A Triple-Blind Randomized Controlled Trial.

Abstract

Introduction Severe pain, nausea, and vomiting after tonsillectomy surgery are among the issues that not only affect patient satisfaction but also may result in complications and delay patient discharge. This study was conducted to assess the effect of intravenous administration of ondansetron on the analgesic action of intravenous acetaminophen after tonsillectomy in children. Materials and methods. This randomized controlled trial was conducted on 53 children between the age of 3 and 12 years old who were referred to Besat Hospital Hamadan, Iran, for tonsillectomy. Patients were randomly assigned to two groups. The intervention group (I) received intravenous acetaminophen plus 0.1 mg/kg ondansetron intravenously while the control group (C) received intravenous acetaminophen plus 2 ml of normal saline intravenously. Postoperative pain severity was assessed using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS). Frequency of nausea, vomiting, and need for analgesic was assessed and recorded four times, at recovery unit, after 6, 12, and 24 hours postsurgery. Data analysis was performed at 95% confidence level using the statistical package for social sciences (SPSS) software version 21. Results The number of patients in groups I and C was 27 and 26 patients, respectively. Mean pain score in I and C groups was 4.48 and 2.88 at recovery unit, 2.74 and 2.04 after 6 hours, 1.67 and 0.81 after 12 hours, and 0.67 and 0.20 after 24 hours postsurgery, respectively. Frequency of nausea at recovery unit was 23.1% in I group and 0.0% in group C (p = 0.010) while the mean number of analgesic requirements in I and C groups was 1.07 and 0.56 times, respectively (p = 0.027). Conclusions Intravenous administration of 0.1 mg/kg ondansetron reduces the analgesic action of intravenous acetaminophen after tonsillectomy in 3 to 12-year-old children.