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

ConditionsOxycodoneAnalgesiaMechanical VentilationPostoperativeRemifentanil
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 ≤ Age ≤ 80

Intubated and mechanically ventilated < 3 days prior to enrollment

Expected need for continuous mechanical ventilation ≥ 24 hours

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oxycodone Hydrochloride

    Drug

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

  • Remifentanil

    Drug

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Oxycodone HydrochlorideExperimental treatment 1 intervention
Group B: RemifentanilActive comparator 1 intervention

Trial outcomes

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.

Time frame
Mechanical ventilation within 7 days after administration of analgesics.

Secondary outcomes

1

Days without mechanical ventilation

Collect relevant data by case form

Time frame
Within 28 days after administration
2

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

Time frame
Within 28 days after administration
3

Ventilator-associated pneumonia

Assessed according to diagnostic criteria

Time frame
Within 28 days after administration
4

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.

Time frame
Within 28 days after administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: