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

Analgesia Clinical Trial

Official title:

Efficacy and Safety of Oxycodone Hydrochloride and Remifentanil for Long-term Analgesia During Invasive Mechanical Ventilation in Postoperative Patients: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444997
• Other study ID #: B2024-161R
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Shanghai Zhongshan Hospital
• Contact: Yunhang Zhang
• Phone: 19542814786
• Email: zhang.yunhang[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

1. Does oxycodone hydrochloride effectively lower the CPOT (Critical Care Pain Observation Tool) score in mechanically ventilated patients?

2. What medical problems do participants have when using oxycodone hydrochloride? Researchers will compare oxycodone hydrochloride to remifentanil to see if oxycodone works better to manage pain in these patients.

Participants will:

• 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.

Description:

This study is a single-center, single-blind, randomized controlled exploratory study involving subjects aged 18 to 80 who are expected to require mechanical ventilation for ≥24 hours and who were intubated and received mechanical ventilation for less than 3 days before enrollment. Subjects will be treated with either oxycodone hydrochloride injection or remifentanil injection and will be randomly assigned in a 1:1 ratio, giving each subject a 50% chance of being assigned to the control group.

Trial Group: Subjects will receive oxycodone hydrochloride injection at a dose of 0.03-0.2 mg/kg/h. Pain scores will be assessed every 15 minutes until the CPOT (Critical Care Pain Observation Tool) score is less than 3. After achieving the target pain score, pain scores will be assessed every 4 hours.

Control Group: Subjects will receive remifentanil hydrochloride injection at a dose of 2-9 μg/kg/h. Pain scores will be assessed every 15 minutes until the CPOT score is less than 3. After achieving the target pain score, pain scores will be assessed every 4 hours.

During this period, the vital signs and monitoring data of the subjects will be recorded. Analgesia and sedation scores will be recorded from days 1 to 7 after administration, and the analgesic and sedative drug dosages will be adjusted based on the subjects' pain scores. Additionally, the incidence of adverse reactions and changes in gastrointestinal function will be observed and recorded from days 1 to 7 after administration.

There are no biological detection indicators in this study; all evaluations are made by the researchers through scoring sheets and will not affect the subjects' normal treatment. If a subject is extubated and weaned off the ventilator within 7 days, relevant data will be collected based on the time of extubation. On the 28th day after administration, doctors will follow up via the electronic medical record system to gather data on the extubation success rate, incidence of complications, and other relevant indicators within the 28-day period.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Mechanical Ventilation
• Oxycodone
• Postoperative
• Remifentanil

Intervention

Drug:
• Oxycodone Hydrochloride
Oxycodone hydrochloride will be administered at a continuous infusion dose of 0.03-0.2 mg/kg/h.
• Remifentanil
Remifentanil will be administered at a continuous infusion dose of 2-9 µg/kg/h.

Locations

Country	Name	City	State
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Days without mechanical ventilation	Collect relevant data by case form	Within 28 days after administration
Secondary	Successful extubation rate	Defined as not using non-invasive or invasive mechanical ventilation within 48 hours after the first spontaneous breathing trial (SBT) in 28 days	Within 28 days after administration
Secondary	Ventilator-associated pneumonia	Assessed according to diagnostic criteria	Within 28 days after administration
Secondary	Delirium	Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The CAM-ICU provides a binary outcome: the presence or absence of delirium. The assessment results in either a positive or negative diagnosis for delirium, where a positive result indicates the presence of delirium and a worse outcome for the patient.	Within 28 days after administration
Secondary	Length of Stay (LOS) in ICU	Collect relevant data by case form	From ICU admission to ICU discharge (typically within 1 to 4 weeks)
Secondary	Change in gastrointestinal function within 7 days of dosing	Gastrointestinal Failure (GIF) score. The score ranges from 0 to 4, a higher GIF score signifies a more severe gastrointestinal dysfunction and a worse outcome for the patient.	Postdose 1, 2, 3, 4, 5, 6, 7 days
Secondary	Adverse Event (AE) incidence rate	Investigator assessment by observation	7 days postdose