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

NCT06444997 | Not Yet Recruiting Phase 4

• 1 other identifier: B2024-161R
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if oxycodone hydrochloride works to manage pain in patients requiring mechanical ventilation. It will also assess the safety of oxycodone hydrochloride. The main questions it aims to answer are:

• Receive either oxycodone hydrochloride injection at a dose of 0.03-0.2 mg/kg/h or remifentanil injection at a dose of 2-9 μg/kg/h.
• Have their pain scores assessed every 15 minutes until the CPOT score is less than 3. After reaching the target pain score, assessments will be done every 4 hours.
• Have their vital signs and monitoring data recorded.
• Have analgesia and sedation scores recorded from days 1 to 7 after administration, with drug dosages adjusted based on pain scores.
• Have the incidence of adverse reactions and changes in gastrointestinal function observed and recorded from days 1 to 7 after administration.
• If extubated within 7 days, relevant data will be collected based on the time of extubation.
• Be followed up on day 28 through the electronic medical record system to gather data on the extubation success rate and incidence of complications within the 28-day period.

Conditions

Oxycodone; Analgesia; Mechanical Ventilation; Postoperative; Remifentanil

Keywords

Oxycodone; oxycodone hydrochloride; long term analgesic; Analgesia; Mechanical Ventilation; Remifentanil; Pilot Study; ICU

Outcome Measures

Primary Outcomes (1)

• Percentage of time with Critical care Pain Observation Tool (CPOT) < 3 without rescue analgesia within 7 days of mechanical ventilation.

  By CPOT Form.

  Mechanical ventilation within 7 days after administration of analgesics.

Secondary Outcomes (7)

• Days without mechanical ventilation

  Within 28 days after administration

• Successful extubation rate

  Within 28 days after administration

• Ventilator-associated pneumonia

  Within 28 days after administration

• Delirium

  Within 28 days after administration

• Length of Stay (LOS) in ICU

  From ICU admission to ICU discharge (typically within 1 to 4 weeks)

Study Arms (2)

Oxycodone Hydrochloride

EXPERIMENTAL

Continuous infusion therapy

Drug: Oxycodone Hydrochloride

Remifentanil

ACTIVE COMPARATOR

Continuous infusion therapy

Drug: Remifentanil

Interventions

Oxycodone Hydrochloride DRUG

Oxycodone hydrochloride will be administered at a continuous infusion dose of 0.03-0.2 mg/kg/h.

Oxycodone Hydrochloride

Remifentanil DRUG

Remifentanil will be administered at a continuous infusion dose of 2-9 μg/kg/h.

Remifentanil

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ Age ≤ 80
• Intubated and mechanically ventilated \&lt; 3 days prior to enrollment
• Expected need for continuous mechanical ventilation ≥ 24 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Agnosia

Interventions

Oxycodone; Remifentanil

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ming Zhong

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunhang Zhang

CONTACT

19542814786; zhang.yunhang@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 6, 2024
• Study Start: June 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: December 31, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)