Oxycodone (10, 20 mg) in a Postoperative Dressing

Study Overview
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Brief Summary
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The study mainly focuses on pain management using 10- or 20mg oxycodone burn wound dressing at Poznan University of Medical Sciences.

Detailed Description
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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.

Official Title
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Oxycodone (10, 20 mg) in a Postoperative Dressing in Patients After Surgical Debridement of Burn Wounds. A Prospective, Double-blinded, Randomized, Controlled Trial.

Conditions
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Burns

Intervention / Treatment
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* Drug: Oxycodone 10mg
* Drug: Oxycodone 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults scheduled for surgical burn treatment aged > 18 years ASA physical status 1,2 or 3 Exclusion Criteria: opioid abuse ASA physical status 4, 5

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (10mg oxycodone)<br>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. | Drug: Oxycodone 10mg<br>* 10mg of oxycodone was added to Octenisept in the wound dressing.<br>* Other names: 10mg oxycodone;|
| Active Comparator: Group B (20mg oxycodone)<br>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. | Drug: Oxycodone 20mg<br>* 20mg of oxycodone was added to Octenisept in the wound dressing.<br>* Other names: 20mg oxycodone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum morphine concentration level [ng/ml] | Measurement of the serum morphone concentration on the day of the procedure | Measured on the day of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS score | 0- no pain, 10- the worst pain | Measured on the day of the procedure |