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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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.

Eligibility criteria

Qualifiers

ICU patients who are intubated are expected to require mechanical ventilation for more than 6h

patients or their guardians have a full understanding of the purpose and significance of this trial, and voluntarily participate in this clinical trial and sign an informed consent form

Disqualifiers

Allergy or unsuitability to any composition of study drugs or propofol

Living expectancy of less than 48 hours

Neurological disorder and any other condition interfering with sedation assessment

Gastrointestinal obstruction

Trial design

Treatments tested in this trial

  • Nalbuphine hydrochloride injection
  • Hydromorphone hydrochloride injection

Treatment groups

204 Participants
are divided into 5 treatment groups

Sponsors and collaborators