Median effective dose of intravenous nalmefene for preventing sufentanil-induced cough in children aged 1–6 years: a prospective randomized controlled trial

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Background Sufentanil-induced cough (SIC) during anesthetic induction carries greater risks in young children than in adults owing to their limited functional residual capacity and elevated oxygen demand. No optimal prophylactic dose of intravenous nalmefene has been established for this age group. We aimed to determine the median effective dose (ED50) of nalmefene for preventing SIC in children aged 1–6 years. Methods In this prospective, randomized, double-blind, placebo-controlled trial (ChiCTR2500111207), 249 children aged 1–6 years undergoing elective laparoscopic surgery were assigned 1:1:1:1 to normal saline (Group A) or nalmefene 0.025, 0.05, or 0.1 μg/kg (Groups B, C, and D), each administered one minute before sufentanil 0.2 μg/kg. The primary endpoint was SIC incidence within one minute of sufentanil injection. The ED50 was estimated using a three-parameter sigmoidal Emax model with bootstrap confidence intervals. Results SIC incidence declined dose-dependently: 45.9% (Group A), 38.1% (Group B), 30.2% (Group C), and 11.3% (Group D). Groups A vs. D and B vs. D differed significantly (both P < 0.05, Bonferroni-corrected). Severe cough was eliminated in Group D versus 16.4% in Group A ( P < 0.05). No between-group differences were detected in hemodynamic parameters or postoperative FLACC scores ( P = 0.267). The ED50 was 0.064 μg/kg (95% CI: 0.036–0.096 μg/kg); the estimated ED95 was 0.242 μg/kg (95% CI: 0.114–1.948 μg/kg), requiring extrapolation beyond the observed dose range. Conclusions Intravenous nalmefene prevents SIC dose-dependently in children aged 1–6 years. The ED50 of 0.064 μg/kg provides a clinically applicable reference dose that preserves hemodynamic stability and postoperative analgesia. Trial registration Chinese Clinical Trial Registry, ChiCTR2500111207 (prospectively registered 25 February 2025).

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