Non-steroidal Anti-inflammatory in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-27

Study Completion Date

2027-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Acute Postoperative Pain Non-steroidal Anti-inflammatory Drugs Cardiac Surgery Pain Intensity Multimodal Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ketoprofen

Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration

Group Type EXPERIMENTAL

pain management

Intervention Type 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

Intervention Type DRUG

Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration

Placebo

Placebo twice a day, during 48 h after surgery, intravenous administration

Group Type PLACEBO_COMPARATOR

pain management

Intervention Type 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

PLacebo

Intervention Type DRUG

Placebo twice a day, during 48 h after surgery, intravenous administration

Interventions

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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

Intervention Type DRUG

ketoprofen

Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration

Intervention Type DRUG

PLacebo

Placebo twice a day, during 48 h after surgery, intravenous administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No