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

Launched by WUHAN UNION HOSPITAL, CHINA · Jan 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called nalbuphine hydrochloride, which is given as an injection to help relieve pain in patients who are on mechanical ventilation in the Intensive Care Unit (ICU) due to respiratory issues. The trial is taking place at multiple sites and is designed in two steps. In the first step, researchers will find the best dosage of the medication, while the second step will involve giving this dosage to patients and observing how well it works and if there are any side effects.

To participate in this trial, patients need to be in the ICU, be intubated (have a tube inserted to help them breathe), and are expected to need mechanical ventilation for more than six hours. It's important that patients or their guardians fully understand the trial and agree to participate by signing a consent form. However, there are certain conditions that would exclude someone from joining, such as having allergies to the study drugs, serious liver or kidney issues, or needing deep sedation. Participants can expect to receive either the study medication or a standard treatment and will be carefully monitored throughout the trial to ensure their safety and well-being.

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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