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Non-steroidal Anti-inflammatory in Cardiac Surgery

NCT06381063 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2025-07-23

No results posted yet for this study

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.

Conditions

  • Acute Postoperative Pain
  • Non-steroidal Anti-inflammatory Drugs
  • Cardiac Surgery
  • Pain Intensity
  • Multimodal Pain Management

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

Sponsors & Collaborators

  • University Hospital, Rouen

    collaborator OTHER

  • University Hospital, Lille

    collaborator OTHER

  • University Hospital, Caen

    collaborator OTHER

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2027-03-31
Completion
2027-07-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06381063 on ClinicalTrials.gov