efficacy, compatibility and potential side effects of oral Targin® in the treatment of postoperative pain after major cardiac surgery. Therefore, we compare the standardized postoperative pain control using PCA with novice oral Targin® combined with oral Oxynorm®.
Conditions
Interventions
Trade Name: TARGIN retard 10 mg
Pharmaceutical Form: Capsule
CAS Number: 76-42-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: Vendal
Pharmaceuti
Sponsors
Med. Uni. Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age from 18 to 90 years • ASA physical status 1-3 • Elective major cardiac surgery requiring sternotomy • Oral and written consent • Postoperative extubation within four hours after arrival at the ICU • Cognitive ability in the use of the PCA pump and the VAS 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: 1. Chronic use of opiods in the last three months 2. Chronic use of tranquilizer or pain medications 3. Hypersensitivity against opiods 4. Use of monoamine oxidase inhibitors in the last two weeks before surgery 5. Alcohol or drug abuse 6. Renal dysfunction (GFR < 30 or necessity of dialysis) 7. Liver Dysfunction defined as Child-Pugh-Score 7-15 8. Ejection fraction (EF< 40%) 9. Malabsorption syndrome 10. Neurologic or cognitive dysfunction 11. Pregnancy 12. Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Total doses of each drug in both treatment groups within the first 72 postoperative hours, administered in so-called “morphine equivalentsâ€.9 The administration of drugs is based on the basic/bolus principle. ;Secondary Objective: Patient`s evaluation of pain The subjective level of pain will be evaluated using the VAS by the nurse and the patient itself.. ;Primary end point(s): Total doses of each drug in both treatment groups within the first 72 postoperative hours;Timepoint(s) of evaluation of this end point: The subjective level of pain | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 72 hours;Timepoint(s) of evaluation of this end point: 72 hours | — |
Countries
Austria
Contacts
Public ContactProf. Koinig
Med. Univ. Wien
Outcome results
None listed