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

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.

Timeline

Start

2023-08-30

Primary completion

2025-10-31

Completion

2025-10-31

Publications

• Zhang Y, Yuan Y, Ren L, Jiang W, Sun S, Wang R, Li Z, Peng Q, Gong R, Yang X, Shang Y. Protocol for a multicenter, randomized, single-blind, non-inferiority trial comparing nalbuphine hydrochloride versus hydromorphone hydrochloride for analgesia in mechanically ventilated ICU patients. Front Pharmacol. 2026 Apr 28;17:1795531. doi: 10.3389/fphar.2026.1795531. eCollection 2026.

Drugs

Indications