OxycodonePhase 4NCT06444997
Efficacy and Safety of Oxycodone Hydrochloride for Long-term Analgesia in ICU Patients
A Phase 4 study testing Oxycodone Hydrochloride and Remifentanil in people with Oxycodone and Analgesia, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Oxycodone, Analgesia, Mechanical Ventilation
- What is being tested?
- Oxycodone Hydrochloride and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 ≤ Age ≤ 80
- Intubated and mechanically ventilated \< 3 days prior to enrollment
- Expected need for continuous mechanical ventilation ≥ 24 hours
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Yunhang Zhang, 19542814786, zhang.yunhang@zs-hospital.sh.cn
About this study
Official title: Efficacy and Safety of Oxycodone Hydrochloride and Remifentanil for Long-term Analgesia During Invasive Mechanical Ventilation in Postoperative Patients: A Pilot Study
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:
- Does oxycodone hydrochloride effectively lower the CPOT (Critical Care Pain Observation Tool) score in mechanically ventilated patients?
- 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.
Read more
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.
Read the detailed 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.
- Conditions
- Oxycodone, Analgesia, Mechanical Ventilation, Postoperative, Remifentanil
- Being tested
- Oxycodone Hydrochloride, Remifentanil
- Keywords
- Oxycodone, oxycodone hydrochloride, long term analgesic, Analgesia, Mechanical Ventilation, Remifentanil, Pilot Study, ICU
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone HydrochlorideDrug
Oxycodone hydrochloride will be administered at a continuous infusion dose of 0.03-0.2 mg/kg/h.
RemifentanilDrug
Remifentanil will be administered at a continuous infusion dose of 2-9 μg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone Hydrochloride | Experimental | Continuous infusion therapy Receives: Drug: Oxycodone Hydrochloride |
| Remifentanil | Active comparator | Continuous infusion therapy Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time with Critical care Pain Observation Tool (CPOT) < 3 without rescue analgesia within 7 days of mechanical ventilation.
By CPOT Form.
Measured: Mechanical ventilation within 7 days after administration of analgesics.
Secondary outcomes (7)
Days without mechanical ventilation
Collect relevant data by case form
Measured: Within 28 days after administration
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
Measured: Within 28 days after administration
Ventilator-associated pneumonia
Assessed according to diagnostic criteria
Measured: Within 28 days after administration
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.
Measured: Within 28 days after administration
Length of Stay (LOS) in ICU
Collect relevant data by case form
Measured: From ICU admission to ICU discharge (typically within 1 to 4 weeks)
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.
Measured: Postdose 1, 2, 3, 4, 5, 6, 7 days
Adverse Event (AE) incidence rate
Investigator assessment by observation
Measured: 7 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Jun 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OxycodoneStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Zhong, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444997
- Sponsor's protocol ID
- B2024-161R
- Status last verified
- Jun 2024
- First submitted
- 24 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oxycodone Hydrochloride and Remifentanil for Long-term Analgesia During Invasive Mechanical Ventilation in Postoperative Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT06444997
- Acronym / sponsor ID
- B2024-161R
- Conditions
- Oxycodone, Analgesia, Mechanical Ventilation, Postoperative, Remifentanil
- Keywords
- Oxycodone, oxycodone hydrochloride, long term analgesic, Analgesia, Mechanical Ventilation, Remifentanil, Pilot Study, ICU
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does oxycodone hydrochloride effectively lower the CPOT (Critical Care Pain Observation Tool) score in mechanically ventilated patients?
- 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone Hydrochloride | Experimental | Drug: Oxycodone HydrochlorideContinuous infusion therapy |
| Remifentanil | Active comparator | Drug: RemifentanilContinuous infusion therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 ≤ Age ≤ 80
- Intubated and mechanically ventilated \< 3 days prior to enrollment
- Expected need for continuous mechanical ventilation ≥ 24 hours
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone HydrochlorideOxycodone hydrochloride will be administered at a continuous infusion dose of 0.03-0.2 mg/kg/h. | Drug | Oxycodone Hydrochloride |
| RemifentanilRemifentanil will be administered at a continuous infusion dose of 2-9 μg/kg/h. | Drug | Remifentanil |
Primary outcome
Percentage of time with Critical care Pain Observation Tool (CPOT) < 3 without rescue analgesia within 7 days of mechanical ventilation.
Time frame: Mechanical ventilation within 7 days after administration of analgesics.
By CPOT Form.
7 secondary outcomes
Days without mechanical ventilation
Time frame: Within 28 days after administration
Successful extubation rate
Time frame: Within 28 days after administration
Ventilator-associated pneumonia
Time frame: Within 28 days after administration
Delirium
Time frame: Within 28 days after administration
Length of Stay (LOS) in ICU
Time frame: From ICU admission to ICU discharge (typically within 1 to 4 weeks)
Change in gastrointestinal function within 7 days of dosing
Time frame: Postdose 1, 2, 3, 4, 5, 6, 7 days
Adverse Event (AE) incidence rate
Time frame: 7 days postdose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Zhong principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone Hydrochloride and Remifentanil in people with Oxycodone and Analgesia, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunhang Zhang (19542814786, zhang.yunhang@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time with Critical care Pain Observation Tool (CPOT) < 3 without rescue analgesia within 7 days of mechanical ventilation. (time frame: Mechanical ventilation within 7 days after administration of analgesics.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.