Oxycodone (10, 20 mg) in a Postoperative Dressing

Sponsor

Poznan University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT06142591

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Burns	Drug: Oxycodone 10mg Drug: Oxycodone 20mg	Phase 4

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

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Feb 28, 2018

Actual Study Completion Date :

Mar 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Oxycodone 10mg 10mg of oxycodone was added to Octenisept in the wound dressing. Other Names: 10mg oxycodone
Active Comparator: 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.	Drug: Oxycodone 20mg 20mg of oxycodone was added to Octenisept in the wound dressing. Other Names: 20mg oxycodone

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Oxycodone 10mg

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

Other Names:

10mg oxycodone

Active Comparator: 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.

Drug: Oxycodone 20mg

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

Other Names:

20mg oxycodone

Outcome Measures

Primary Outcome Measures

Serum morphine concentration level [ng/ml] [Measured on the day of the procedure]
Measurement of the serum morphone concentration on the day of the procedure

Secondary Outcome Measures

NRS score [Measured on the day of the procedure]
0- no pain, 10- the worst pain

Other Outcome Measures

Dressing morphine concentration [mg/ml] [Measured on the day of the procedure]
Evaluation of the morphine dose

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Poznan University of Medical Sciences

Investigators

Study Director: Katarzyna Wieczorowska-Tobis, Prof.dr hab, Poznań University of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Poznan University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT06142591

Other Study ID Numbers:

7/2023

First Posted:

Nov 21, 2023

Last Update Posted:

Nov 21, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Oxycodone

Study Results

No Results Posted as of Nov 21, 2023