Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

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

Exclusion Criterias

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

Summary

Conditions
  • Cardiac Surgery
  • 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 Criterias

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

Exclusion Criterias

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

Locations

Clermont-Ferrand, 63003
Clermont-Ferrand, 63003

Tracking Information

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