Wirksamkeit Eines Oralen Und Eines Invasiven Opiat-Regimes Nach Herzchirurgischen Operatione

Phase 1

• Conditions: 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®.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2010-024201-12-AT
• Lead Sponsor: Med. Uni. Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-27
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 86

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified