Using non-steroidal anti-inflammatory drugs for pain management after heart surgery
Effect of Non-steroidal Anti-inflammatory Drugs in Pain Management After Cardiac Surgery
PHASE3 · Centre Hospitalier Universitaire, Amiens · NCT06381063
This study tests if using non-steroidal anti-inflammatory drugs can safely help manage pain after heart surgery without causing complications.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 238 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens (other) |
| Locations | 1 site (Amiens) |
| Trial ID | NCT06381063 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) in managing acute postoperative pain in patients undergoing cardiac surgery. The study aims to determine whether NSAIDs can be safely administered in the early postoperative period without increasing the risk of complications such as bleeding or kidney injury. Participants will receive either ketoprofen or a placebo as part of a multimodal pain management strategy. The trial includes patients scheduled for various cardiac procedures and assesses pain intensity and overall recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults scheduled for cardiac surgery who are under cardiopulmonary bypass and affiliated with the French national healthcare system.
Not a fit: Patients who may not benefit from this study include those under 18, those with chronic NSAID use, or those with specific contraindications to NSAIDs or other pain management medications.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective pain management option for patients recovering from cardiac surgery.
How similar studies have performed: Other studies have explored the use of NSAIDs in postoperative pain management, but this specific approach in cardiac surgery is less common and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * scheduled for cardiac surgery (aortic valve replacement, coronary artery bypass graft, mitral valve repair or replacement, intracardiac tumor, aortic root repair) * under cardiopulmonary bypass * Affiliation to the French national healthcare system * Written consent obtained Exclusion Criteria: * age\<18 * weight\<50 kg * chronic use of NSAID * mini-invasive surgery * NSAID contraindication * NSAID allergy * Nefopam contraindication * Paracetamol contraindication * Tramadol contraindication * Urgent surgery * Endocarditis * Immunosuppressive drug * HIV infection with CD4\<200 mm3 * Organ transplantation * Stage 4 or 5 chronic kidney disease * Gastro duodenal ulcer * Pregnancy * Depression * Auto immune disease
Where this trial is running
Amiens
- CHU Amiens Picardie — Amiens, France (RECRUITING)
Study contacts
- Study coordinator: Osama ABOU ARAB, Pr
- Email: abouarab.osama@chu-amiens.fr
- Phone: 03 22 08 78 36
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Postoperative Pain, Non-steroidal Anti-inflammatory Drugs, Cardiac Surgery, Pain Intensity, Multimodal Pain Management, non-steroidal anti-inflammatory drugs, cardiac surgery, pain intensity