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NCT Number: NCT06381063

Non-steroidal Anti-inflammatory in 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.

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Key information

Conditions

Acute Postoperative Pain Cardiac Surgery Multimodal Pain Management Neurologic Manifestations Non-steroidal Anti-inflammatory Drugs Pain Pain Intensity Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens Picardie

Amiens, France

Location status: Recruiting

Location contact

Emmanuel BESNIER, MD

PRINCIPAL_INVESTIGATOR

Mouhamed MOUSSA, MD

PRINCIPAL_INVESTIGATOR

Osama ABOU ARAB

CONTACT

[email protected]

Richard Descamps, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery

    Time frame: at 24 hours

    Pain intensity will be assessed using the NRS at 24 hours from the end of surgery during chest physiotherapy

  2. NSAIDs reduce postoperative at rest at 24 hours from the end of surgery

    Time frame: 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

  1. Change in pain trajectory during the first 7 days after cardiac surgery

    Time frame: 7 days

    Pain trajectory will be assessed every day using NRS and trajectory will be defined as following

  2. Change in cumulative opioid within 48 hours after surgery

    Time frame: 48 hours

    Total dose of oxynorm or morphine will be recorded from the end of surgery to 48 h after and expressed in milligram

  3. Change in pulmonary postoperative complications within 7 days after surgery

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Osama ABOU ARAB, Pr

CONTACT

[email protected]

03 22 08 78 36

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • University Hospital, Caen
  • University Hospital, Lille
  • University Hospital, Rouen

Registry information

Official study title

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

Acronym: KETOPAIN

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 24, 2024
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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