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Nalmefene reduces sufentanil-induced cough incidence to 11.3% at 0.1 μg/kg in childrenNalmefene reduces cough from sufentanil in children

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Key Takeaway
Consider nalmefene at 0.1 μg/kg to reduce sufentanil-induced cough in children during laparoscopic surgery.

This randomized controlled trial enrolled 249 children aged 1–6 years undergoing elective laparoscopic surgery to evaluate nalmefene for preventing sufentanil-induced cough (SIC). Participants were randomized to receive either normal saline or one of three doses of nalmefene: 0.025, 0.05, or 0.1 μg/kg.

The primary outcome was SIC incidence within one minute of sufentanil injection. Results showed that the saline group had a 45.9% SIC incidence. In contrast, nalmefene groups showed lower rates: 38.1% for 0.025 μg/kg, 30.2% for 0.05 μg/kg, and 11.3% for 0.1 μg/kg. Comparisons between the 0.1 μg/kg dose group and both the 0.025 μg/kg and saline groups showed statistically significant differences in SIC incidence (P < 0.05).

Safety data, including specific adverse events or tolerability metrics, were not reported. The study aims to determine the median effective dose (ED50) for preventing cough in this pediatric population. While the results suggest a dose-dependent reduction in SIC, the lack of detailed safety reporting and full p-values for all comparisons limits immediate clinical translation.

How this fits prior evidence

How this fits prior evidence: This study addresses a gap in managing opioid-induced side effects during pediatric surgery. It differs from the reported finding that intranasal naloxone reverses opioid-induced respiratory depression in adults, as this trial focuses on preventing cough specifically in children using nalmefene. While other findings discussed sufentanil combinations for delirium or pain management, this study provides specific data on mitigating immediate procedural complications like coughing.

A new study tested whether nalmefene, a drug that blocks certain opioid effects, could prevent a common side effect of the anesthetic sufentanil: sudden, intense coughing. The study included 249 children aged 1 to 6 years who were having elective laparoscopic surgery. All children received sufentanil, and then they were given either a placebo (normal saline) or one of three doses of nalmefene (0.025, 0.05, or 0.1 micrograms per kilogram).

The main finding was that nalmefene reduced the incidence of sufentanil-induced cough (SIC) in a dose-dependent way. In the placebo group, 45.9% of children coughed within one minute of receiving sufentanil. With the highest nalmefene dose (0.1 mcg/kg), only 11.3% coughed. The differences between the highest dose and placebo, and between the highest and lowest dose, were statistically significant.

No safety concerns were reported in the study summary, but the researchers did not provide details on side effects or how well the children tolerated the medication. This is a single randomized trial, and more research is needed to confirm the results and to determine the best dose. The study was designed to find the median effective dose (ED50) of nalmefene for preventing cough in this age group.

For parents and doctors, this finding suggests that nalmefene might be a useful option to prevent coughing during anesthesia in young children. However, the exact dose is still being worked out, and the study did not report on long-term outcomes or safety in larger groups. Always discuss any concerns about anesthesia with your child's medical team.

What this means for you:
Nalmefene may help prevent coughing from sufentanil in young children, but the best dose is still being studied.

Common questions

What is nalmefene?

Nalmefene is a medication that blocks some effects of opioid drugs. In this study, it was used to prevent coughing caused by the anesthetic sufentanil in children.

How much did nalmefene reduce coughing?

In the study, coughing occurred in 45.9% of children who got a placebo. With the highest dose of nalmefene (0.1 mcg/kg), only 11.3% coughed.

Is nalmefene safe for children?

The study did not report any side effects or safety problems. However, this was a single trial, and more research is needed to fully understand the safety of nalmefene in young children.

Who was in the study?

The study included 249 children aged 1 to 6 years who were having elective laparoscopic surgery. They all received the anesthetic sufentanil.

Study Details

Study typeRct
EvidenceLevel 2
PublishedJul 2026
View Original Abstract ↓
BackgroundSufentanil-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.MethodsIn 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.ResultsSIC 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 
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