Non-steroidal Anti-inflammatory in Cardiac Surgery (KETOPAIN)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery; Acute Postoperative Pain; Pain Intensity; Multimodal Pain Management; Non-steroidal Anti-inflammatory Drugs
• Intervention / Treatment: Drug: pain management; Drug: ketoprofen; Drug: PLacebo

• Study Type: Interventional
• Enrollment (Estimated): 238
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Osama ABOU ARAB, Pr; Phone Number: 03 22 08 78 36; Email: abouarab.osama@chu-amiens.fr

Study Locations

• France
  • Amiens, France
    • Recruiting
    • CHU Amiens Picardie
    • Contact: Osama ABOU ARAB; Email: abouarab.osama@chu-amiens.fr
    • Principal Investigator: Emmanuel Besnier, MD
    • Principal Investigator: Mouhamed MOUSSA, MD
    • Principal Investigator: Richard Descamps, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketoprofen; Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration	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
Placebo Comparator: Placebo; Placebo twice a day, during 48 h after surgery, intravenous administration	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: PLacebo; Placebo twice a day, during 48 h after surgery, intravenous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: University Hospital, Rouen; University Hospital, Caen; University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: cardiac surgery; pain intensity; non-steroidal anti-inflammatory drugs; Acute Postoperative Pain; multimodal pain management
• Additional Relevant MeSH Terms: Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Ketoprofen
• Other Study ID Numbers: PI2023_843_0152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No