RecruitingPhase 3Other

Non-steroidal Anti-inflammatory in Cardiac Surgery

NCT ID

NCT06381063

Target Enrollment

238 participants

Start Date

2024-03-27

Est. Completion

2027-07

About This Study

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.

Conditions Studied

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

Interventions

•pain management
•ketoprofen
•PLacebo

Eligibility

Age:18 Years - N/A

Healthy Volunteers:No

View full eligibility 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

Study Locations (1)

CHU Amiens Picardie

Amiens, France