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Non-steroidal Anti-inflammatory in Cardiac Surgery

ConditionsAcute Postoperative PainNon-steroidal Anti-inflammatory DrugsCardiac SurgeryPain IntensityMultimodal Pain Management
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

age<18

weight<50 kg

chronic use of NSAID

mini-invasive surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

238 Participants
are divided into 2 treatment groups
Group A: KetoprofenExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
at 24 hours
2

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)

Time frame
at 24 hours

Secondary outcomes

1

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

Time frame
7 days
2

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

Time frame
48 hours
3

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

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire, Amiens

Lead sponsor

University Hospital, Rouen

Collaborator

University Hospital, Lille

Collaborator

University Hospital, Caen

Collaborator

Source ClinicalTrials.gov
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