Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

Patients scheduled for a cardiac surgery (Coronary artery bypass graft, valve replacement)
Absence of criteria for non-inclusion
Weight between 60 and 100 kg
...
Patients scheduled for a cardiac surgery (Coronary artery bypass graft, valve replacement)
Absence of criteria for non-inclusion
Weight between 60 and 100 kg
Age over 18 years

Exclusion Criteria

Allergy to NSAIDs
Preoperative coagulation trouble
Congestive heart failure (EF <40%)
...
Allergy to NSAIDs
Preoperative coagulation trouble
Congestive heart failure (EF <40%)
Hepatic Insufficiency
Peptic ulcer scalable, history of peptic ulcer or recurrent bleeding (2 or more distinct episodes of bleeding or ulceration objectified)
Insulin-requiring diabetes
Surgery in emergency, aorta surgery, heart transplantation
Renal insufficiency (MDRD <60 ml / min)
Pregnant or lactating women
Age over 75 years
Major protected
History of peptic ulcer or gastrointestinal bleeding

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

Patients scheduled for a cardiac surgery (Coronary artery bypass graft, valve replacement)
Absence of criteria for non-inclusion
Weight between 60 and 100 kg
...
Patients scheduled for a cardiac surgery (Coronary artery bypass graft, valve replacement)
Absence of criteria for non-inclusion
Weight between 60 and 100 kg
Age over 18 years

Exclusion Criteria

Allergy to NSAIDs
Preoperative coagulation trouble
Congestive heart failure (EF <40%)
...
Allergy to NSAIDs
Preoperative coagulation trouble
Congestive heart failure (EF <40%)
Hepatic Insufficiency
Peptic ulcer scalable, history of peptic ulcer or recurrent bleeding (2 or more distinct episodes of bleeding or ulceration objectified)
Insulin-requiring diabetes
Surgery in emergency, aorta surgery, heart transplantation
Renal insufficiency (MDRD <60 ml / min)
Pregnant or lactating women
Age over 75 years
Major protected
History of peptic ulcer or gastrointestinal bleeding

Tracking Information

NCT #
NCT02180087
Collaborators
Not Provided
Investigators
  • Principal Investigator: Vedat ELJEZI University Hospital, Clermont-Ferrand
  • Vedat ELJEZI University Hospital, Clermont-Ferrand