Randomised Placebo Controlled Trial of Celecoxib for Acute Burn Inflammation and Fever

Phase 4

Recruiting

• Conditions: Acute burn injury; Injuries and Accidents - Burns

• Registration Number: ACTRN12618000732280
• Lead Sponsor: Fiona Stanley Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-02
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Less than 48 hours from admission to the burns unit with acute burn injury
OR
Outpatient booked for day of surgery admission for management of acute burn injury

Exclusion Criteria

i. Regular NSAID use prior to injury (including any dose aspirin)
ii. Major burn with TBSA>20% or requiring admission to the intensive care unit
iii. Enrolment not considered in the patient’s best interest
iv. Previously enrolled in the CABIN Fever study
v. Participating in a competing interventional study
vi. Pregnancy or breast feeding
vii. NSAID or sulphonamide allergy
viii. Renal dysfunction (eGFR <60)
ix. Angina, myocardial infarction, heart failure (NYHA class II or greater: ordinary physical activity results in fatigue, palpitations or dyspnoea)
x. Previous history of peripheral arterial disease or stroke
xi. Current use of angiotensin converting enzyme inhibitor or angiotensin II receptor blocker
xii. Suspected or confirmed hepatic cirrhosis, portal hypertension or variceal bleeding
xiii. Current ALT 3x upper limit of normal or Bilirubin 2x upper limit of normal
xiv. Previous history of gastric ulcer or gastrointestinal bleeding
xv. Current systemic corticosteroid use
xvi. Suspected or confirmed haemophilia
xvii. Current use of anticoagulant medications including warfarin, new oral anticoagulants (NOACs) such as apixaban, dabigatran and rivaroxaban and treatment dose heparin
xviii. Suspected or confirmed thrombophilia or previous history of thromboembolism

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intention to treat analysis (including all randomised study participants) of scar quality as measured by participant reported Patient Observer Scar Assessment Scale[day 42 post-enrolment]