Oxycodone (10, 20 mg) in a Postoperative Dressing

NCT ID: NCT06142591

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2022-03-03

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.

Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group A (10mg oxycodone)

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.

Group Type ACTIVE_COMPARATOR

Oxycodone 10mg

Intervention Type DRUG

10mg of oxycodone was added to Octenisept in the wound dressing.

Group B (20mg oxycodone)

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.

Group Type ACTIVE_COMPARATOR

Oxycodone 20mg

Intervention Type DRUG

20mg of oxycodone was added to Octenisept in the wound dressing.

Interventions

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Oxycodone 10mg

10mg of oxycodone was added to Octenisept in the wound dressing.

Intervention Type DRUG

Oxycodone 20mg

20mg of oxycodone was added to Octenisept in the wound dressing.

Intervention Type DRUG

Other Intervention Names

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10mg oxycodone 20mg oxycodone

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katarzyna Wieczorowska-Tobis, Prof.dr hab

Role: STUDY_DIRECTOR

PoznaƄ University of Medical Sciences

Other Identifiers

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7/2023

Identifier Type: -

Identifier Source: org_study_id