Evaluation of Nalbuphine Hydrochloride Injection for Pain Relief in ICU Patients with Respiratory Insufficiency: A Randomized, Multicenter Two-Step Trial

What this Trial Is About

Researchers are evaluating the pain relief effects and safety of nalbuphine hydrochloride injection in patients in intensive care units (ICU) who require mechanical ventilation due to respiratory insufficiency. This multicenter, randomized, single-blind, parallel study is conducted in two steps. The first step explores the optimal dose of nalbuphine hydrochloride by comparing two experimental doses with a positive control drug. The second step assesses the effectiveness and safety of the selected nalbuphine dose compared to the control in ventilated ICU patients. Participants receive a loading dose of nalbuphine hydrochloride injection administered over 30 b110 seconds, followed by a maintenance dose of 2.0 mg per hour. The maintenance dose can range from 1.0 to 5.0 mg per hour based on the study design. The control group receives hydromorphone hydrochloride injection with a maintenance dose of 0.5 mg per hour (recommended range 0.5 to 3.0 mg per hour). The study is structured to carefully monitor dosing and analgesic effects during treatment. Patients are monitored closely for pain control success within 24 hours while receiving the study drug. The study involves assessments of analgesic effectiveness, safety, and tolerability in ICU patients who are intubated and expected to require mechanical ventilation for more than six hours. Researchers also evaluate adverse events and overall treatment safety throughout the trial period, which includes informed consent and careful patient selection based on eligibility criteria.

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