Non-steroidal Anti-inflammatory in Cardiac Surgery

Cardiac Surgery Clinical Trial

— KETOPAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381063
• Other study ID #: PI2023_843_0152
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2024
• Est. completion date: July 2027

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Osama ABOU ARAB, Pr
• Phone: 03 22 08 78 36
• Email: abouarab.osama[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 238
• Est. completion date: July 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Postoperative Pain
• Cardiac Surgery
• Multimodal Pain Management
• Pain
• Pain Intensity
• Pain, Postoperative

Intervention

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
• ketoprofen
Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration
• PLacebo
Placebo twice a day, during 48 h after surgery, intravenous administration

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	University Hospital, Lille, University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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	48 hours
Secondary	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