The Effects of Different Doses of Nalbuphine and Esketamine on Prevention of Emergence Agitation in Preschool Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial

Purpose: Emergence agitation (EA) is a frequent complication in preschool children following adenotonsillectomy. This study evaluated the efficacy of intravenous nalbuphine versus esketamine for EA prophylaxis in this population. Patients and Methods: In this randomized, double-blind trial, 98 children (aged 3– 7 years) undergoing adenotonsillectomy were analysed via a modified intention-to-treat approach. Patients received esketamine 0.25 mg/kg (Group E, n=33), nalbuphine 0.1 mg/kg (Group N1, n=33), or nalbuphine 0.2 mg/kg (Group N2, n=32) approximately 10 minutes before surgery completion. The primary outcome was EA incidence (maximum Pediatric Anesthesia Emergence Delirium PAED score ≥ 12 within 30 minutes post-extubation). Secondary outcomes included exploratory longitudinal Face, Legs, Activity, Cry, and Consolability (FLACC) scores, haemodynamics, and adverse events. Results: EA incidence was significantly lower in Group N2 (6.25%) than Group E (39.39%) (Relative Risk RR = 0.16; 95% CI: 0.04– 0.65; Bonferroni-adjusted P = 0.006). The difference between Group N1 (21.21%) and Group E was not statistically significant (RR = 0.54; 95% CI: 0.25– 1.18; P = 0.354). Exploratory repeated-measures analyses showed Group N2 provided superior analgesia and more stable heart rates postoperatively compared to Group E ( P = 0.004 for FLACC; P = 0.002 for heart rate). Extubation times and adverse event rates were comparable across groups ( P = 0.482 and P > 0.999, respectively). Conclusion: Prophylactic nalbuphine (0.2 mg/kg) significantly reduces EA incidence in preschool children undergoing adenotonsillectomy compared with esketamine. Exploratory findings suggest it provides stable analgesia and haemodynamics without delaying recovery. These results may inform paediatric anaesthesia guidelines, warranting further multicentre validation. Keywords: adenotonsillectomy, emergence agitation, esketamine, nalbuphine