BurnsPhase 4NCT06142591
Oxycodone (10, 20 mg) in a Postoperative Dressing
A Phase 4 study testing Oxycodone 10mg and Oxycodone 20mg in people with Burns, run by Poznan University of Medical Sciences.
Trial summary
The study mainly focuses on pain management using 10- or 20mg oxycodone burn wound dressing at Poznan University of Medical Sciences. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Burns
- What is being tested?
- Oxycodone 10mg and Oxycodone 20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 3 Mar 2022
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults scheduled for surgical burn treatment
- aged > 18 years
- ASA physical status 1,2 or 3
Who cannot join
- opioid abuse
- ASA physical status 4, 5
About this study
Official title: Oxycodone (10, 20 mg) in a Postoperative Dressing in Patients After Surgical Debridement of Burn Wounds. A Prospective, Double-blinded, Randomized, Controlled Trial.
The study mainly focuses on pain management using 10- or 20mg oxycodone burn wound dressing at Poznan University of Medical Sciences.
Read the detailed description
Subjects were randomly assigned to one of the two treatment groups, A and B. Patients scheduled for burn surgery will sign written consent pre-operatively about procedural pain management. Group A received 10mg of oxycodone in wound dressing, while those in Group B received 20mg of oxycodone in wound dressing.
- Conditions
- Burns
- Being tested
- Oxycodone 10mg, Oxycodone 20mg
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone 10mgDrug
Also called 10mg oxycodone
10mg of oxycodone was added to Octenisept in the wound dressing.
Oxycodone 20mgDrug
Also called 20mg oxycodone
20mg of oxycodone was added to Octenisept in the wound dressing.
| Study group | Role | What they receive |
|---|---|---|
| Group A (10mg oxycodone) | Active comparator | The burn wound was covered with a three-layer sterile dressing. The first layer was a dressing soaked in Octanisept (a solution of octenidine dihydrochloride and phenoxyethanol) with 10mg Oxycodone, the second dressing with paraffin, and the third dry dressing. Octenisept (Schulke\&Mayer Poland, 1000ml) is a disinfectant liquid. The 1 gram of Octenisept contains 1 mg of octenidine dihydrochloride and 20 mg of Phenoxyethanol. Receives: Drug: Oxycodone 10mg |
| Group B (20mg oxycodone) | Active comparator | The burn wound was covered with a three-layer sterile dressing. The first layer was a dressing soaked in Octanisept (a solution of octenidine dihydrochloride and phenoxyethanol) with 20mg Oxycodone, the second dressing with paraffin, and the third dry dressing. Octenisept (Schulke\&Mayer Poland, 1000ml) is a disinfectant liquid. The 1 gram of Octenisept contains 1 mg of octenidine dihydrochloride and 20 mg of Phenoxyethanol. Receives: Drug: Oxycodone 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum morphine concentration level [ng/ml]
Measurement of the serum morphone concentration on the day of the procedure
Measured: Measured on the day of the procedure
Secondary outcomes (1)
NRS score
0- no pain, 10- the worst pain
Measured: Measured on the day of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Jan 2016
- Primary completion28 Feb 2018
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katarzyna Wieczorowska-Tobis, Prof.dr hab, Study director, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142591
- Sponsor's protocol ID
- 7/2023
- Status last verified
- Nov 2023
- First submitted
- 11 Oct 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxycodone (10, 20 mg) in a Postoperative Dressing in Patients After Surgical Debridement of Burn Wounds. A Prospective, Double-blinded, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT06142591
- Acronym / sponsor ID
- 7/2023
- Conditions
- Burns
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 21 Nov 2023 (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 study mainly focuses on pain management using 10- or 20mg oxycodone burn wound dressing at Poznan University of Medical Sciences.
Detailed description
Subjects were randomly assigned to one of the two treatment groups, A and B. Patients scheduled for burn surgery will sign written consent pre-operatively about procedural pain management. Group A received 10mg of oxycodone in wound dressing, while those in Group B received 20mg of oxycodone in wound dressing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (10mg oxycodone) | Active comparator | Drug: Oxycodone 10mgThe burn wound was covered with a three-layer sterile dressing. The first layer was a dressing soaked in Octanisept (a solution of octenidine dihydrochloride and phenoxyethanol) with 10mg Oxycodone, the second dressing with paraffin, and the third dry dressing. Octenisept (Schulke\&Mayer Poland, 1000ml) is a disinfectant liquid. The 1 gram of Octenisept contains 1 mg of octenidine dihydrochloride and 20 mg of Phenoxyethanol. |
| Group B (20mg oxycodone) | Active comparator | Drug: Oxycodone 20mgThe burn wound was covered with a three-layer sterile dressing. The first layer was a dressing soaked in Octanisept (a solution of octenidine dihydrochloride and phenoxyethanol) with 20mg Oxycodone, the second dressing with paraffin, and the third dry dressing. Octenisept (Schulke\&Mayer Poland, 1000ml) is a disinfectant liquid. The 1 gram of Octenisept contains 1 mg of octenidine dihydrochloride and 20 mg of Phenoxyethanol. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults scheduled for surgical burn treatment
- aged > 18 years
- ASA physical status 1,2 or 3
Key exclusion criteria (2 listed)
- opioid abuse
- ASA physical status 4, 5
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 10mgAlso: 10mg oxycodone10mg of oxycodone was added to Octenisept in the wound dressing. | Drug | Group A (10mg oxycodone) |
| Oxycodone 20mgAlso: 20mg oxycodone20mg of oxycodone was added to Octenisept in the wound dressing. | Drug | Group B (20mg oxycodone) |
Primary outcome
Serum morphine concentration level [ng/ml]
Time frame: Measured on the day of the procedure
Measurement of the serum morphone concentration on the day of the procedure
1 secondary outcome
NRS score
Time frame: Measured on the day of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
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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.
Katarzyna Wieczorowska-Tobis, Prof.dr hab study director
Poznań University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone 10mg and Oxycodone 20mg in people with Burns, run by Poznan University of Medical Sciences.
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 2 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: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum morphine concentration level [ng/ml] (time frame: Measured on the day of the procedure). 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 21 Nov 2023.