Trial reportDrug design, development and therapy2026
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.
Trial report in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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5 authors.
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Abstract
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 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.
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