Cardiac Surgery Clinical Trial
— KETOPAINOfficial title:
Effect of Non-steroidal Anti-inflammatory Drugs in Pain Management After Cardiac Surgery
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.
Status | Recruiting |
Enrollment | 238 |
Est. completion date | July 2027 |
Est. primary completion date | March 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens Picardie | Amiens |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens | University Hospital, Lille, University Hospital, Rouen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | at 24 hours | |
Primary | 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) | at 24 hours | |
Secondary | 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 | 7 days | |
Secondary | 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 | 48 hours | |
Secondary | 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 | 7 days |
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