Non-steroidal Anti-inflammatory in Cardiac Surgery

Phase 3RecruitingNCT06381063

Centre Hospitalier Universitaire, Amiens238 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

238

Conditions

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

Interventions

pain managementDRUG

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

ketoprofenDRUG

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

PLaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery

Pain intensity will be assessed using the NRS at 24 hours from the end of surgery during chest physiotherapy

Time frame: at 24 hours

NSAIDs reduce postoperative at rest at 24 hours from the end of surgery

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)

Time frame: at 24 hours

Secondary Outcomes

Change in pain trajectory during the first 7 days after cardiac surgery

Pain trajectory will be assessed every day using NRS and trajectory will be defined as following

Time frame: 7 days

Change in cumulative opioid within 48 hours after surgery

Total dose of oxynorm or morphine will be recorded from the end of surgery to 48 h after and expressed in milligram

Time frame: 48 hours

Change in pulmonary postoperative complications within 7 days after surgery

Postoperative pulmonary complications will be defined by the occurrence of at least one item among following: atelectasis, pneumonia, acute respiratory distress syndrome, acute respiratory failure, bronchospasm