Oxycodone (10, 20 mg) in a Postoperative Dressing

Poznan University of Medical Sciences (PUMS)

Status and phase: Completed; Phase 4

Conditions: Burns

Treatments: Drug: Oxycodone 20mg; Drug: Oxycodone 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06142591

7/2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Group A (10mg oxycodone)

Active Comparator group

Description:

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.

Treatment:

Drug: Oxycodone 10mg

Group B (20mg oxycodone)

Active Comparator group

Description:

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.

Treatment:

Drug: Oxycodone 20mg