Non-steroidal Anti-inflammatory in Cardiac Surgery (KETOPAIN)

Centre Hospitalier Universitaire, Amiens

Status and phase: Enrolling; Phase 3

Conditions: Cardiac Surgery; Pain Intensity; Non-steroidal Anti-inflammatory Drugs; Multimodal Pain Management; Acute Postoperative Pain

Treatments: Drug: ketoprofen; Drug: PLacebo; Drug: pain management

Study type: Interventional

Funder types: Other

Identifiers

NCT06381063

PI2023_843_0152

Details and patient eligibility

About

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.

Enrollment: 238 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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238 participants in 2 patient groups, including a placebo group

Ketoprofen

Experimental group

Description:

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

Treatment:

Drug: pain management

Drug: ketoprofen

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: pain management

Drug: PLacebo