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50% Efficacy Dose of Intravenous Nalmefene in Suppressing Sufentanil-Induced Cough in Preschool Children

50% Efficacy Dose of Intravenous Nalmefene in Suppressing Sufentanil-Induced Cough in Preschool Children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111207
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-03-18
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Cough

Interventions

Group A :0.1ug/kg nalmefene
Group B :0.05ug/kg nalmefene
Group C:0.025ug/kgnalmefene
Group D :Placebo saline

Sponsors

Beijing Children’s Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1.1 ~ 6 years old ,including 1 and 6 years old; 2.Children who are scheduled for surgery; 3.ASA I-II; 4.The parent or legal guardian signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Children undergoing emergency surgery; 2.With severe cardiopulmonary disease or other organ diseases; 3.A history of severe allergies or allergies to any drugs in the study; 4.Obese children with BMI>=24.0; 5.A history of chronic cough, steroid or bronchodilator therapy, airway reactive disease; 6.Upper respiratory tract infection within 2 weeks; 7.The use of medications or nutritional supplements to affect blood pressure (BP) and heart rate (HR); 8.Treatment with angiotensin-converting enzyme inhibitors; 9.More than two attempts at intubation; 10.Upper gastrointestinal active bleeding and other children with high reflux aspiration; 11.Children who had used opioids within the last week; 12.Children whose legal guardians do not sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Incindece of cough;

Countries

China

Contacts

Public ContactWang Fang

Beijing Children’s Hospital, Capital Medical University

wangfang@bch.com.cn+86 189 1061 9300

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 22, 2026