Acute Postoperative Pain, Cardiac Surgery, Multimodal Pain Management, Non-steroidal Anti-inflammatory Drugs, Pain Intensity
Conditions
Keywords
Acute Postoperative Pain, non-steroidal anti-inflammatory drugs, cardiac surgery, pain intensity, multimodal pain management
Brief 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.
Interventions
DRUGpain 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
DRUGketoprofen
Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration
DRUGPLacebo
Placebo twice a day, during 48 h after surgery, intravenous administration
Sponsors
University Hospital, Rouen
University Hospital, Lille
University Hospital, Caen
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery | at 24 hours | Pain intensity will be assessed using the NRS at 24 hours from the end of surgery during chest physiotherapy |
| NSAIDs reduce postoperative at rest at 24 hours from the end of surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in pain trajectory during the first 7 days after cardiac surgery | 7 days | Pain trajectory will be assessed every day using NRS and trajectory will be defined as following |
| Change in cumulative opioid within 48 hours after surgery | 48 hours | Total dose of oxynorm or morphine will be recorded from the end of surgery to 48 h after and expressed in milligram |
| Change in pulmonary postoperative complications within 7 days after surgery | 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 |
Countries
France
Contacts
Primary ContactOsama ABOU ARAB, Pr
Outcome results
None listed