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

Summary

This prospective, randomized, double-blind, placebo-controlled trial included 249 children aged 1–6 years and evaluated nalmefene doses before sufentanil administration. Sufentanil-induced cough declined dose-dependently, from 45.9% with saline to 11.3% with nalmefene 0.1 μg/kg, with an estimated ED50 of 0.064 μg/kg and preserved hemodynamic stability and postoperative analgesia.

Key Findings

• The trial enrolled 249 children aged 1–6 years and was prospectively registered under ChiCTR2500111207.
• Sufentanil-induced cough decreased from 45.9% with saline to 11.3% with nalmefene 0.1 μg/kg.
• The estimated nalmefene ED50 was 0.064 μg/kg, with preserved hemodynamic stability and postoperative analgesia.

Clinical Implications

Nalmefene around the estimated ED50 may be considered as a prophylactic strategy for sufentanil-induced cough in children aged 1–6 years, while monitoring for opioid-antagonist effects and confirming efficacy in broader surgical populations.

Limitations

• The study evaluated elective laparoscopic surgery and may not generalize to emergency surgery or other pediatric procedures.
• The abstract provides limited information on adverse events beyond hemodynamic stability and postoperative analgesia.

Future Directions

Future multicenter trials should confirm the dose across different ages, surgical settings, opioid regimens, and respiratory-risk groups, while systematically evaluating analgesia, withdrawal-related effects, and rare adverse events.