Ireland
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Recruiting Phase 3

Non-steroidal Anti-inflammatory in Cardiac Surgery

NCT06381063 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2024-03-27
Last updated
2025-07-23

Condition(s) studied

Acute Postoperative PainNon-steroidal Anti-inflammatory DrugsCardiac SurgeryPain IntensityMultimodal Pain Management

Investigational drug(s) / intervention(s)

pain managementketoprofen →PLacebo

pain management: o Pain management in both arms Intraoperative time: intravenous ketamine 0.5 mg kg-1, intravenous dexamethasone 8 mg Postoperative time: paracetamol 1 g every 6 hours a day, nefopam 20 every 8 hours a day, patient control analgesia with morphine or oxycontin

ketoprofen: Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration

PLacebo: Placebo twice a day, during 48 h after surgery, intravenous administration

Study summary

Non-steroidal anti-inflammatory drugs (NSAID) are part the multimodal strategy in pain management after surgery. However, major concerns are raised in cardiac surgery given the potential side effects of NSAID with more bleeding and acute kidney injury. The investigators hypothesized that NSAID are safe in the early postoperative course after cardiac surgery with respect to contraindication.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery — at 24 hours
    Pain intensity will be assessed using the NRS at 24 hours from the end of surgery during chest physiotherapy
  • NSAIDs reduce postoperative at rest at 24 hours from the end of surgery — at 24 hours
    Pain intensity will be assessed at rest at 24 hours from the end surgery using the numerous rating scale (NRS) graded from 1 (no pain) to 10 (high pain intensity)

Trial sites (1)

FacilityCityRegionStatus
CHU Amiens Picardie Amiens France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06381063 on ClinicalTrials.gov ↗ ← All trials in France