Efficacy and Safety of Oxycodone Hydrochloride for Long-term Analgesia in ICU Patients

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Jun 5, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to find out if oxycodone hydrochloride is effective and safe for managing pain in patients who are on mechanical ventilation. It will compare oxycodone to another pain medication called remifentanil to see which works better at reducing pain levels. The researchers will keep track of how much pain patients feel using a specific pain scale, check their vital signs, and monitor any side effects over a week. They will also follow up after 28 days to see how patients are doing after their treatment.

To participate in this study, patients need to be between 18 and 80 years old, have been intubated and on a ventilator for less than three days, and will need to stay on the ventilator for at least 24 hours. However, there are certain health issues that would exclude someone from joining the trial, such as severe liver or kidney problems, certain types of shock, or a history of substance abuse. If eligible, participants can expect to receive either oxycodone or remifentanil and will be closely monitored for their pain and overall health during the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 ≤ Age ≤ 80
• • Intubated and mechanically ventilated \< 3 days prior to enrollment
• • Expected need for continuous mechanical ventilation ≥ 24 hours
• Exclusion Criteria:
• • Patients requiring deep sedation (e.g., mechanical ventilation patients with severe man-machine dyssynchrony, respiratory distress due to severe respiratory failure, application of neuromuscular blockers, status epilepticus, surgical procedures requiring strict immobilization, mild hypothermia treatment, etc.);
• • Chronic kidney disease, severe liver dysfunction (Child-Pugh Class C)
• • Severe shock requiring norepinephrine ≥ 0.5 µg/kg/min
• • American Society of Anesthesiologists (ASA) Class 5 patients (near death)
• • Nerve injury or organic pathological changes in the brain
• • Need for designated sedatives or anesthetics other than study drug during treatment
• • Patients with chronic pain, frequently taking strong opioids, such as morphine
• • History of alcohol or drug abuse
• • Participation in other opioid studies within 30 days
• • Pregnant or lactating women
• • Patients with study drug allergy and contraindications Patients who are not suitable for inclusion in the study as judged by the investigator