Comparison between nalbuphine versus dexmedetomidine for prevention of emergence agitation in pediatrics during sevoflurane anesthesia: prospective randomized controlled clinical trial

Background This study was designed to compare the effect of nalbuphine versus dexmedetomidine on the incidence of post-operative emergence agitation (EA) in pediatric patients undergoing elective lower abdominal surgical procedures during anesthesia with sevoflurane.Methods A prospective, controlled trial of 135 children aged 3–6 years scheduled for elective lower abdominal surgery was randomly assigned to one of the three equal groups receiving either nalbuphine 0.1 mg/kg IV (Group N), dexmedetomidine 0.5 mic/kg IV in (Group D) or a saline solution (Group C) at 10 min before the end of surgery in a double-blind manner. Post-operative EA was assessed with pediatric anesthesia emergence delirium (PAED) scale.Results The incidence of EA was significantly low in children in Group N and Group D compared to placebo group (p = 0.011) with no significant difference between Group N and Group D. The number of patients receiving nalbuphine and post-operative nalbuphine consumption during PACU stay were significantly higher in Group C than in Groups N and D (p = 0.024 and 0.001 respectively) with no significant differences between Group N and Group D. There was no significant difference regarding pain between the three groups at 5, 10, 20 and 30 min postoperatively. No significant difference among groups regarding the time to Aldrete score. The overall incidence of vomiting in our study was similar in the three groups.Conclusion Nalbuphine 0.1 mg/kg was comparable to dexmedetomidine 0.5 mic/kg for decreasing the incidence and severity of EA in the PACU in sevoflurane-anesthetized children when administered intravenously 10 min before the end of surgery.Trial registration This study was registered at ClinicalTrials.gov NCT05273671 (10/03/2022).