Post-operative pain with poor response to intravenous morphine. MedDRA version: 8.1 Level: LLT Classification code 10054711 Term: Postoperative pain
Conditions
Interventions
Trade Name: ketalar
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
Trade Name: CATAPRESSAN
Sponsors
ERASME HOSPITAL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients in the immediate postoperative period with a pain score remaining above 3, on a 10 points scale, after intravenous injection of 10 mg of morphine, given by 2 mg boluses every 5 minutes. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Allergy to one of the study drugs. Uncontrolled hypertension. Hypotension. Intracanial hypertension. Morbid obesity. Pregnancy or breast feeding. Severe bradycardia. Patient's inability to score his pain. Cardiac, hepatic, or renal failure. Age younger than 18 year. Peroperative use of ketamine or clonidinel drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduce the time to obtain a postoperative pain score smaller than 4 on a 10 points scale, after injection of ketamine and clonidine when compared to placebo.;Secondary Objective: Reduce the amount of morphine to obtain a postoperative pain score smaller than 4 on a 10 points scale. Increase the time of a further injection of morphine after initial pain relief. ;Primary end point(s): The time to obtain a postoperative pain score smaller than 4 on a 10 points scale, after injection of ketamine and clonidine when compared to placebo. | — |
Countries
Belgium
Outcome results
None listed