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NCT06142591 Clinical Trial

Oxycodone (10, 20 mg) in a Postoperative Dressing

Burns Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06142591
Other study ID # 7/2023
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2016
Est. completion date March 3, 2022

Study information
Verified date November 2023
Source Poznan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 3, 2022
Est. primary completion date February 28, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oxycodone 10mg
10mg of oxycodone was added to Octenisept in the wound dressing.
• Oxycodone 20mg
20mg of oxycodone was added to Octenisept in the wound dressing.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Poznan University of Medical Sciences

Outcome
Type Measure Description Time frame Safety issue
Other Dressing morphine concentration [mg/ml] Evaluation of the morphine dose Measured on the day of the procedure
Primary 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 NRS score 0- no pain, 10- the worst pain Measured on the day of the procedure
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