Objective:

To determine the median effective dose (ED50) of intravenous nalmefene for preventing sufentanil-induced cough (SIC) in children aged 1–6 years.

Approach:

• Study Design: A prospective, randomized, double-blind, placebo-controlled trial involving 249 children aged 1–6 years undergoing elective laparoscopic surgery.
• Intervention: Participants were assigned to receive either normal saline or nalmefene at doses of 0.025, 0.05, or 0.1 μg/kg, administered one minute before sufentanil.
• Endpoints: The primary endpoint was the incidence of SIC within one minute of sufentanil injection, with ED50 estimated using a three-parameter sigmoidal Emax model.

Key Findings:

• SIC incidence decreased dose-dependently: 45.9% (Group A), 38.1% (Group B), 30.2% (Group C), and 11.3% (Group D).
• Severe cough was eliminated in Group D compared to 16.4% in Group A.
• The ED50 of nalmefene was determined to be 0.064 μg/kg (95% CI: 0.036–0.096 μg/kg).

Interpretation:

Limitations:

• The study's findings may not be generalizable beyond the specific age group and surgical procedures evaluated.
• The ED95 was estimated to be 0.242 μg/kg, requiring extrapolation beyond the observed dose range.

Conclusion:

Sources:

• Chinese Clinical Trial Registry