Oxycodone (10, 20 mg) in a Postoperative Dressing

NCT06142591 | Completed Phase 4

• 1 other identifier: 7/2023
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• NRS score

  Measured on the day of the procedure

Other Outcomes (1)

• Dressing morphine concentration [mg/ml]

  Measured on the day of the procedure

Study Arms (2)

Group A (10mg oxycodone)

ACTIVE COMPARATOR

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

Group B (20mg oxycodone)

ACTIVE COMPARATOR

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

Interventions

Oxycodone 10mg DRUG

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

Also known as: 10mg oxycodone

Group A (10mg oxycodone)

Oxycodone 20mg DRUG

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

Also known as: 20mg oxycodone

Group B (20mg oxycodone)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults scheduled for surgical burn treatment
• aged \> 18 years
• ASA physical status 1,2 or 3

You may not qualify if:

• opioid abuse
• ASA physical status 4, 5

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

MeSH Terms

Conditions

Burns

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Katarzyna Wieczorowska-Tobis, Prof.dr hab

  Poznań University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: November 21, 2023
• Study Start: January 1, 2016
• Primary Completion: February 28, 2018
• Study Completion: March 3, 2022
• Last Updated: November 21, 2023

Record last verified: 2023-11