Protocol for a multicenter, randomized, single-blind, non-inferiority trial comparing nalbuphine hydrochloride versus hydromorphone hydrochloride for analgesia in mechanically ventilated ICU patients

Abstract

Introduction: Despite the established use of nalbuphine hydrochloride in anesthesia and obstetrics, high-quality evidence supporting its application in the intensive care unit (ICU) remains limited. This study aims to assess the efficacy and safety of nalbuphine hydrochloride for analgesia in ICU patients.

Methods: This is a multicenter, randomized, single-blind, parallel, positive control study. Eligible patients are randomly assigned to receive nalbuphine hydrochloride or hydromorphone hydrochloride in a 1:1 ratio. Nalbuphine hydrochloride is compared against hydromorphone hydrochloride which serves as the positive control. The study drug infusion is discontinued after 24 h (±10 min) of administration.

Planned outcomes: The primary outcome is the analgesic success rate during 24 h of study drug administration. The secondary outcomes include the following: 1) The percentage of time within CPOT score ≤2 and RASS score between -2 and +1 during 24 h of study drug administration. 2) The frequency and dosage of rescue sedation during 24 h of study drug administration. 3) The proportion of patients requiring rescue sedation during 24 h of study drug administration. 4) The total cumulative dose of rescue sedative during 24 h of study drug administration. 5) The time to successful weaning and ICU discharge during 24 h of study drug administration. 6) The weaning success rate and the proportion of patients discharged from the ICU.

Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT06785571, identifier NCT06785571.

Keywords: analgesia; hydromorphone hydrochloride; intensive care; mechanical ventilation; nalbuphine hydrochloride.