Study of Ketoprofen for Pain Relief After Cardiac Surgery Using Cardiopulmonary Bypass
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-07-23
238
Participants Needed
1
Research Sites
17 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of non-steroidal anti-inflammatory drugs NSAIDs for managing pain after cardiac surgery. The focus is on evaluating ketoprofen compared to a placebo in reducing pain without increasing risks such as bleeding or kidney injury during the early postoperative period. This phase 3 randomized trial aims to address concerns about NSAID use following heart surgeries like valve replacements and bypass grafts.
Participants are randomly assigned to receive either intravenous ketoprofen at 100 mg twice daily or a placebo twice daily for 48 hours after surgery. Both groups receive standard pain management during and after surgery, including intravenous ketamine and dexamethasone during the operation, and paracetamol, nefopam, and patient-controlled morphine or oxycontin afterward. The study uses triple masking to keep patients, caregivers, and researchers unaware of group assignments.
During the study, participants undergo pain assessments, especially pain intensity during chest physiotherapy at 24 hours after surgery, and tracking of opioid use and pulmonary complications over the first week. Researchers monitor pain changes daily for seven days and observe any side effects or complications. Total participation includes the immediate postoperative period and follow-up for a week to evaluate the safety and pain control benefits of ketoprofen after cardiac surgery.
CONDITIONS
Brief Title
Non-steroidal Anti-inflammatory in Cardiac Surgery
Research Team
O
Osama ABOU ARAB, Pr
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Scheduled for cardiac surgery (aortic valve replacement, coronary artery bypass graft, mitral valve repair or replacement, intracardiac tumor, aortic root repair)
Under cardiopulmonary bypass
Affiliated with the French national healthcare system
Written consent obtained
You will not qualify if you...
Age under 18
Weight under 50 kg
Chronic use of NSAIDs
Mini-invasive surgery
NSAID contraindication
NSAID allergy
Nefopam contraindication
Paracetamol contraindication
Tramadol contraindication
Urgent surgery
Endocarditis
Use of immunosuppressive drugs
HIV infection with CD4 count less than 200 mm3
Organ transplantation
Stage 4 or 5 chronic kidney disease
Gastro duodenal ulcer
Pregnancy
Depression
Autoimmune disease
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 48 hours after surgery
Participants receive intravenous ketoprofen 100 mg or placebo twice a day for 48 hours after cardiac surgery along with standard pain management.
Intraoperative administration and multiple doses over 2 days
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Effect of non-steroidal anti-inflammatory drugs on the management of postoperative pain after cardiac surgery: a multicenter, randomized, controlled, double-blind trial (KETOPAIN Study).