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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
Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Summary
The analgesic effect of nalbuphine hydrochloride injection will be evaluated in a multicenter, randomized, single-blind, parallel, positive-controlled approach in two steps: step 1, to explore the optimal dosage of nalbuphine hydrochloride injection with 2 experimental arms and 1 positive control and step 2, to evaluate the effectiveness and safety of nalbuphine hydrochloride injection in mechanically ventilated ICU patients at a dosage determined in step 1 with the same positive control.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
204
Start Date
2023-08-30
Completion Date
2025-10-31
Last Updated
2025-01-21
Healthy Volunteers
No
Conditions
Interventions
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)
Hydromorphone hydrochloride injection
A maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h)
Locations (1)
Wuhan Union Hospital
Wuhan, Hubei, China