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

Recruiting now · Phase 2/Phase 3

Conditions studied: Respiratory Insufficiency

In brief

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.

Key facts

Study ID

NCT06785571

Run by

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

People needed

204

Starts

2023-08-30

Expected to finish

2025-10-31

Last updated by the study team

2025-01-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Asthmatic
• Abdominal compartment syndrome
• Serious hepatic dysfunction (CTP 10-15)
• Acute kidney injury (KDIGO stage 2 or 3) or Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/min/1.73m2
• Circulatory instability (the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain proper blood pressure)
• Need deep sedation or paralytics
• Anticipation to receive operations (including tracheotomy)
• Abuse of controlled substances or alcohol
• Pregnancy, lactation, or an intention of gestation in 6 months
• Inclusion in another interventional trial in the past 30 days
• Other conditions deemed unsuitable to be included

Where it is running

• Wuhan Union Hospital — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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