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Phase 3
Age: 18Years +
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ID06381063

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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