RecruitingPhase 3NCT06381063

Non-steroidal Anti-inflammatory in Cardiac Surgery

Effect of Non-steroidal Anti-inflammatory Drugs in Pain Management After Cardiac Surgery


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

238 participants

Start Date

Mar 27, 2024

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria19

  • 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

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Interventions

DRUGpain 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

DRUGketoprofen

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

DRUGPLacebo

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


Locations(1)

CHU Amiens Picardie

Amiens, France

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NCT06381063