Effect of Non-steroidal Anti-inflammatory Drugs in Pain Management After Cardiac Surgery
Overview
- Phase
- Phase 3
- Intervention
- pain management
- Conditions
- Acute Postoperative Pain
- Sponsor
- Centre Hospitalier Universitaire, Amiens
- Enrollment
- 238
- Locations
- 1
- Primary Endpoint
- NSAIDs reduce postoperative at rest at 24 hours from the end of surgery
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief 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.
Investigators
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
- •weight\<50 kg
- •chronic use of NSAID
- •mini-invasive surgery
- •NSAID contraindication
- •NSAID allergy
- •Nefopam contraindication
- •Paracetamol contraindication
- •Tramadol contraindication
- •Urgent surgery
- •Endocarditis
Arms & Interventions
Ketoprofen
Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration
Intervention: pain management
Ketoprofen
Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration
Intervention: ketoprofen
Placebo
Placebo twice a day, during 48 h after surgery, intravenous administration
Intervention: pain management
Placebo
Placebo twice a day, during 48 h after surgery, intravenous administration
Intervention: PLacebo
Outcomes
Primary Outcomes
NSAIDs reduce postoperative at rest at 24 hours from the end of surgery
Time Frame: at 24 hours
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)
reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery
Time Frame: at 24 hours
Pain intensity will be assessed using the NRS at 24 hours from the end of surgery during chest physiotherapy
Secondary Outcomes
- Change in pain trajectory during the first 7 days after cardiac surgery(7 days)
- Change in cumulative opioid within 48 hours after surgery(48 hours)
- Change in pulmonary postoperative complications within 7 days after surgery(7 days)