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Clinical observation of nalmefene in preventing fentanyl-induced cough during induction of children general anesthesia: a randomized, double-blind, placebo-controlled trial

Nalmefene pretreatment suppresses fentanyl-induced cough in children during general anesthesia induction: a randomized, double-blind, placebo-controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038971
Enrollment
Unknown
Registered
2020-10-11
Start date
2020-10-25
Completion date
Unknown
Last updated
2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fentanyl-induced cough

Interventions

Intervention group 1:nalmefene 0.05ug/kg
Intervention group 2:nalmefene 0.1ug/kg
intervention group 3:nalmefene 0.2ug/kg

Sponsors

The Children's Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 2-10 years, the body weight is ± 15% of the ideal body weight, regardless of gender; 2. Patients with ASA grade I - II, the estimated operation time was less than 90 min; 3. Children undergoing laparoscopic hernia repair under selective general anesthesia; 4. Patients whose guardians clearly understand, voluntarily participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of hearing impairment or visual impairment; 2. Patients with history of bronchial asthma and respiratory tract infection in recent 4 weeks; 3. Patients with tongue and mouth deformity and history of allergy to any narcotic drugs; 4. Patients with congenital heart disease or severe heart, lung, liver and kidney dysfunction, and patients taking psychotropic drugs; 5. Patients who can't cooperate with serious crying.

Design outcomes

Primary

MeasureTime frame
The incidence and extent of fentanyl induced cough;

Secondary

MeasureTime frame
Wong-Baker pain rating scale;NIBP;HR;SpO2;Face, Legs, Activity, Cry and Consolability scores;

Countries

China

Contacts

Public ContactXia Chen

Children's Hospital Affiliated to Suzhou University

chenxiaa95@126.com+86 18362608023

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026