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

• Status: RECRUITING
• Trial end date: 2025-10-31

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.

• Phase: PHASE2

Details

• Lead Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Collaborator: Yichang Humanwell Pharmaceutical Co., Ltd., China
• Treatments: Hydromorphone; Nalbuphine