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Completed

NCT Number: NCT06142591

Oxycodone (10, 20 mg) in a Postoperative Dressing

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

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Key information

Conditions

Burns Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone 10mg

Drug

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

Other names: 10mg oxycodone

Oxycodone 20mg

Drug

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

Other names: 20mg oxycodone

Primary outcomes

  1. Serum morphine concentration level [ng/ml]

    Time frame: Measured on the day of the procedure

    Measurement of the serum morphone concentration on the day of the procedure

Secondary outcomes

  1. NRS score

    Time frame: Measured on the day of the procedure

    0- no pain, 10- the worst pain

Other outcomes

  1. Dressing morphine concentration [mg/ml]

    Time frame: Measured on the day of the procedure

    Evaluation of the morphine dose

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

Oxycodone (10, 20 mg) in a Postoperative Dressing in Patients After Surgical Debridement of Burn Wounds. A Prospective, Double-blinded, Randomized, Controlled Trial.

Important dates

Study start
2016
Primary completion
2018
Study completion
2022
First posted
Nov 21, 2023
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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