Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital, Rouen | OTHER |
| University Hospital, Lille | OTHER |
| University Hospital, Caen | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketoprofen | Experimental | Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration |
|
| Placebo | Placebo Comparator | Placebo twice a day, during 48 h after surgery, intravenous administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 24 hours |
| 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) | at 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days |
| Change in cumulative opioid within 48 hours after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Osama ABOU ARAB, Pr | Contact | 03 22 08 78 36 | abouarab.osama@chu-amiens.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie | Recruiting | Amiens | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39285437 | Derived | Huette P, Moussa M, Diouf M, Lefebvre T, Bayart G, Guilbart M, Viart C, Haye G, Bar S, Caus T, Soriot-Thomas S, Boddaert S, Alshatri HY, Tarpin P, Fumery O, Beyls C, Dupont H, Mahjoub Y, Besnier E, Abou-Arab O. 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). Trials. 2024 Sep 16;25(1):613. doi: 10.1186/s13063-024-08326-z. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D059408 | Pain Management |
| D007660 | Ketoprofen |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D019468 | Disease Management |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
|
Total dose of oxynorm or morphine will be recorded from the end of surgery to 48 h after and expressed in milligram
| 48 hours |
| 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 | 7 days |
| D012816 | Signs and Symptoms |
| D010666 |
| Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |