Non-steroidal Anti-inflammatory in Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: pain management, ketoprofen, PLacebo.
- Who it may be relevant to
- Registry conditions: Acute Postoperative Pain, Non-steroidal Anti-inflammatory Drugs, Cardiac Surgery, Pain Intensity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Non-steroidal Anti-inflammatory Drugs in Pain Management After Cardiac Surgery
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.
Interventions
- Drug pain management
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 - Drug ketoprofen
Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration - Drug PLacebo
Placebo twice a day, during 48 h after surgery, intravenous administration
Primary outcome measures
- reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery [Time frame: at 24 hours]
- NSAIDs reduce postoperative at rest at 24 hours from the end of surgery [Time frame: at 24 hours]
Secondary outcome measures (3)
- Change in pain trajectory during the first 7 days after cardiac surgery [Time frame: 7 days]
- Change in cumulative opioid within 48 hours after surgery [Time frame: 48 hours]
- Change in pulmonary postoperative complications within 7 days after surgery [Time frame: 7 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU Amiens Picardie — Amiens
Publications
- Huette P, Moussa M, Diouf M, Lefebvre T, Bayart G, Guilbart M, Viart C, Haye G, Bar S, Caus T, Soriot-Thomas S, Boddaert S, Alshatri HY, Tarpin P, Fumery O, Beyls C, Dupont H, Mahjoub Y, Besnier E, Abou-Arab O. Effect of non-steroidal anti-inflammatory drugs on the management of postoperative pain after cardiac surgery: a multicenter, randomized, controlled, double-blind trial (KETOPAIN Study). Tr PMID 39285437
Identifiers
NCT: NCT06381063 · PI2023_843_0152