Reduce Nonsteroidal Antiinflammatory Drugs Doses for Analgesia After Sternotomy
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
Inclusion Criteria
- Age over 18 years
- Patients scheduled for a cardiac surgery (Coronary artery bypass graft, valve replacement)
- Absence of criteria for non-inclusion
- ...
- Age over 18 years
- Patients scheduled for a cardiac surgery (Coronary artery bypass graft, valve replacement)
- Absence of criteria for non-inclusion
- Weight between 60 and 100 kg
Exclusion Criteria
- Allergy to NSAIDs
- Insulin-requiring diabetes
- Major protected
- ...
- Allergy to NSAIDs
- Insulin-requiring diabetes
- Major protected
- Renal insufficiency (MDRD <60 ml / min)
- Age over 75 years
- History of peptic ulcer or gastrointestinal bleeding
- Congestive heart failure (EF <40%)
- Peptic ulcer scalable, history of peptic ulcer or recurrent bleeding (2 or more distinct episodes of bleeding or ulceration objectified)
- Preoperative coagulation trouble
- Hepatic Insufficiency
- Pregnant or lactating women
- Surgery in emergency, aorta surgery, heart transplantation
Summary
- Conditions
- Cardiac Surgery
- Post Operative Pain
- Post-operative Pain
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
To answer this hypothesis the investigators will consider starting a study of four groups of patients where appropriate doses to patient weight gradually increasing ketoprofen will be used in seeking the minimum effective dose. Four groups will be determined by randomization. In all these groups, an...
To answer this hypothesis the investigators will consider starting a study of four groups of patients where appropriate doses to patient weight gradually increasing ketoprofen will be used in seeking the minimum effective dose. Four groups will be determined by randomization. In all these groups, analgesia will be supplemented by a systematic standard self-administered treatment with morphine and paracetamol. Group 1 : Placebo group (P). 0 mg/kg ketoprofen IV every 6 hours for 48 hours (or 0 mg/kg every 24 hours) for 48 hours. Group 2 : "Ketoprofen quarter dose" (K ¼). 0,125 mg/kg ketoprofen IV every 6 hours (0,5 mg/kg every 24 hours) for 48 hours. Group 3 : "Ketoprofen half-dose" (K ½). 0,25 mg/kg ketoprofen IV every 6 hours (1 mg/kg every 24 hours) for 48 hours. Group 4 : "Ketoprofen full dose" (KPD). 0,5 mg/kg ketoprofen IV every 6 hours (or 2 mg/kg every 24 hours) for 48 hours.
Inclusion Criteria
- Age over 18 years
- Patients scheduled for a cardiac surgery (Coronary artery bypass graft, valve replacement)
- Absence of criteria for non-inclusion
- ...
- Age over 18 years
- Patients scheduled for a cardiac surgery (Coronary artery bypass graft, valve replacement)
- Absence of criteria for non-inclusion
- Weight between 60 and 100 kg
Exclusion Criteria
- Allergy to NSAIDs
- Insulin-requiring diabetes
- Major protected
- ...
- Allergy to NSAIDs
- Insulin-requiring diabetes
- Major protected
- Renal insufficiency (MDRD <60 ml / min)
- Age over 75 years
- History of peptic ulcer or gastrointestinal bleeding
- Congestive heart failure (EF <40%)
- Peptic ulcer scalable, history of peptic ulcer or recurrent bleeding (2 or more distinct episodes of bleeding or ulceration objectified)
- Preoperative coagulation trouble
- Hepatic Insufficiency
- Pregnant or lactating women
- Surgery in emergency, aorta surgery, heart transplantation
Tracking Information
- NCT #
- NCT02180087
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Vedat ELJEZI University Hospital, Clermont-Ferrand
- Vedat ELJEZI University Hospital, Clermont-Ferrand
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