Non-steroidal Anti-inflammatory in Cardiac Surgery

NCT06381063 — Phase 3, Recruiting, 238 participants, Centre Hospitalier Universitaire, Amiens

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Effect of Non-steroidal Anti-inflammatory Drugs in Pain Management After Cardiac Surgery

Registry	NCT06381063, acronym KETOPAIN
Status	Recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	238 (Estimated)
Sponsor	Centre Hospitalier Universitaire, Amiens (Other); collaborators: University Hospital, Rouen, University Hospital, Lille, University Hospital, Caen
Conditions	Acute Postoperative Pain, Non-steroidal Anti-inflammatory Drugs, Cardiac Surgery, Pain Intensity, Multimodal Pain Management
Interventions	pain management, ketoprofen, PLacebo (Drug)
Dates	start 2024-03-27, primary completion 2027-03-01 (estimated), completion 2027-07-01 (estimated), first posted 2024-04-24, last updated 2025-07-23
Locations	1 site in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Ketoprofen	Experimental	Drug: pain management; Drug: ketoprofen	Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration
Placebo	Placebo comparator	Drug: pain management; Drug: PLacebo	Placebo twice a day, during 48 h after surgery, intravenous administration

pain management (Drug): 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
ketoprofen (Drug): Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration
PLacebo (Drug): Placebo twice a day, during 48 h after surgery, intravenous administration

+Outcome measures

Primary outcomes

reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery [at 24 hours]: Pain intensity will be assessed using the NRS at 24 hours from the end of surgery during chest physiotherapy
NSAIDs reduce postoperative at rest at 24 hours from the end of surgery [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)

Secondary outcomes

Change in pain trajectory during the first 7 days after cardiac surgery [7 days]: Pain trajectory will be assessed every day using NRS and trajectory will be defined as following
Change in cumulative opioid within 48 hours after surgery [48 hours]: Total dose of oxynorm or morphine will be recorded from the end of surgery to 48 h after and expressed in milligram
Change in pulmonary postoperative complications within 7 days after surgery [7 days]: 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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
CHU Amiens Picardie	Amiens	France	Recruiting

+Publications

Results publication: 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). Trials. 2024 Sep 16;25(1):613. doi: 10.1186/s13063-024-08326-z. PMID 39285437