The Evaluation of the Effectiveness and Safety of Nalbuphine Hydrochloride Injection for Analgesia in ICU Patients: A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

August 30, 2023

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Respiratory Insufficiency
Interventions
DRUG

Nalbuphine hydrochloride injection

a loading dose of Nalbuphine hydrochloride injection administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0\~5.0mg/h)

DRUG

Hydromorphone hydrochloride injection

A maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h)

Trial Locations (1)

430022

RECRUITING

Wuhan Union Hospital, Wuhan

All Listed Sponsors
collaborator

Yichang Humanwell Pharmaceutical Co., Ltd., China

INDUSTRY

lead

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER