Oxycodone (10, 20 mg) in a Postoperative Dressing

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Drug: Oxycodone 10mg; Drug: Oxycodone 20mg

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dressing morphine concentration [mg/ml]	Evaluation of the morphine dose	Measured on the day of the procedure

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Director: Katarzyna Wieczorowska-Tobis, Prof.dr hab, Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): March 3, 2022

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Estimated): November 21, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: 7/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No