Evaluating nalbuphine for pain relief in ICU patients on ventilators

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

This study is testing if nalbuphine can safely help relieve pain for patients in the ICU who are on ventilators.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06785571 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of nalbuphine hydrochloride injection as an analgesic for ICU patients requiring mechanical ventilation. It employs a multicenter, randomized, single-blind, parallel design, consisting of two steps: the first step explores the optimal dosage of nalbuphine with two experimental arms and one positive control, while the second step assesses its effectiveness and safety at the determined dosage. The trial aims to provide a better pain management option for critically ill patients.

Who should consider this trial

Good fit: Ideal candidates include intubated ICU patients expected to require mechanical ventilation for more than 6 hours.

Not a fit: Patients with allergies to study drugs, severe comorbidities, or those requiring deep sedation or paralytics may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve pain management for mechanically ventilated ICU patients, enhancing their comfort and recovery.

How similar studies have performed: Other studies have shown promising results with similar analgesic approaches, but this specific evaluation of nalbuphine is novel.

Eligibility criteria

Inclusion Criteria:

1. ICU patients who are intubated are expected to require mechanical ventilation for more than 6h
2. 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

Exclusion Criteria:

1. Allergy or unsuitability to any composition of study drugs or propofol
2. Living expectancy of less than 48 hours
3. Neurological disorder and any other condition interfering with sedation assessment
4. Gastrointestinal obstruction
5. Asthmatic
6. Abdominal compartment syndrome
7. Serious hepatic dysfunction (CTP 10-15)
8. Acute kidney injury (KDIGO stage 2 or 3) or Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/min/1.73m2
9. Circulatory instability (the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain proper blood pressure)
10. Need deep sedation or paralytics
11. Anticipation to receive operations (including tracheotomy)
12. Abuse of controlled substances or alcohol
13. Pregnancy, lactation, or an intention of gestation in 6 months
14. Inclusion in another interventional trial in the past 30 days
15. Other conditions deemed unsuitable to be included

Where this trial is running

Wuhan, Hubei

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

Study contacts

• Study coordinator: you shang

Conditions: Respiratory Insufficiency