Non-steroidal Anti-inflammatory in Cardiac Surgery
KETOPAIN
Effect of Non-steroidal Anti-inflammatory Drugs in Pain Management After Cardiac Surgery
1 other identifier
interventional
238
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2024
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2024
CompletedFirst Submitted
Initial submission to the registry
April 5, 2024
CompletedFirst Posted
Study publicly available on registry
April 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
July 23, 2025
July 1, 2025
2.9 years
April 5, 2024
July 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (3)
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
Study Arms (2)
Ketoprofen
EXPERIMENTALKetoprofen 100 mg twice a day, during 48 after surgery, intravenous administration
Placebo
PLACEBO COMPARATORPlacebo twice a day, during 48 h after surgery, intravenous administration
Interventions
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 100 mg twice a day, during 48 after surgery, intravenous administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire, Amienslead
- University Hospital, Rouencollaborator
- University Hospital, Lillecollaborator
- University Hospital, Caencollaborator
Study Sites (1)
CHU Amiens Picardie
Amiens, France
Related Publications (1)
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: 39285437DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2024
First Posted
April 24, 2024
Study Start
March 27, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share