Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID06381063

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

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-07-23

238

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Universitaire, Amiens

Lead Sponsor

U

University Hospital, Rouen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the safety and effectiveness of non-steroidal anti-inflammatory drugs (NSAIDs) for managing pain after cardiac surgery. The focus is on evaluating ketoprofen compared to a placebo in reducing pain without increasing risks such as bleeding or kidney injury during the early postoperative period. This phase 3 randomized trial aims to address concerns about NSAID use following heart surgeries like valve replacements and bypass grafts. Participants are randomly assigned to receive either intravenous ketoprofen at 100 mg twice daily or a placebo twice daily for 48 hours after surgery. Both groups receive standard pain management during and after surgery, including intravenous ketamine and dexamethasone during the operation, and paracetamol, nefopam, and patient-controlled morphine or oxycontin afterward. The study uses triple masking to keep patients, caregivers, and researchers unaware of group assignments. During the study, participants undergo pain assessments, especially pain intensity during chest physiotherapy at 24 hours after surgery, and tracking of opioid use and pulmonary complications over the first week. Researchers monitor pain changes daily for seven days and observe any side effects or complications. Total participation includes the immediate postoperative period and follow-up for a week to evaluate the safety and pain control benefits of ketoprofen after cardiac surgery.

CONDITIONS

Brief Title

Non-steroidal Anti-inflammatory in Cardiac Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled for cardiac surgery (aortic valve replacement, coronary artery bypass graft, mitral valve repair or replacement, intracardiac tumor, aortic root repair)
  • Under cardiopulmonary bypass
  • Affiliated with the French national healthcare system
  • Written consent obtained
Not Eligible

You will not qualify if you...

  • Age under 18
  • Weight under 50 kg
  • Chronic use of NSAIDs
  • Mini-invasive surgery
  • NSAID contraindication
  • NSAID allergy
  • Nefopam contraindication
  • Paracetamol contraindication
  • Tramadol contraindication
  • Urgent surgery
  • Endocarditis
  • Use of immunosuppressive drugs
  • HIV infection with CD4 count less than 200 mm3
  • Organ transplantation
  • Stage 4 or 5 chronic kidney disease
  • Gastro duodenal ulcer
  • Pregnancy
  • Depression
  • Autoimmune disease

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 48 hours after surgery

Participants receive intravenous ketoprofen 100 mg or placebo twice a day for 48 hours after cardiac surgery along with standard pain management.

Intraoperative administration and multiple doses over 2 days

Trial Site Locations

Total: 1 location

1

CHU Amiens Picardie

Amiens, France

Actively Recruiting

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Research Team

O

Osama ABOU ARAB, Pr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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).

Pierre Huette, Mouhamed Moussa, Momar Diouf...

https://pubmed.ncbi.nlm.nih.gov/39285437