Oral Oxycodone After Major Cardiac Surgery
Keywords
Abstract
Dates
Last Verified: | 02/28/2014 |
First Submitted: | 03/14/2013 |
Estimated Enrollment Submitted: | 03/18/2013 |
First Posted: | 03/21/2013 |
Last Update Submitted: | 03/24/2014 |
Last Update Posted: | 03/25/2014 |
Actual Study Start Date: | 06/30/2011 |
Estimated Primary Completion Date: | 04/30/2012 |
Estimated Study Completion Date: | 02/28/2013 |
Condition or disease
Intervention/treatment
Drug: Targin/OxyNorm
Drug: Targin/OxyNorm
Drug: PCA
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Active Comparator: Targin/OxyNorm Patients randomized to this study arm will receive Targin as basis pain medication and additional OxyNorm (Oxycodone), if requested by the patients. | Drug: Targin/OxyNorm |
Active Comparator: PCA Patients randomized to this group will receive a PCA pump with morphine. The basic rate is 0.3 mg/h. Patients will be allowed to administer 1 mg each five minutes after a vesting period of five minutes, if subjectively needed. | Drug: PCA |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
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 Exclusion Criteria: - Chronic use of opioids in the last three months - Chronic use of tranquilizer or pain medications - Hypersensitivity against opioids - Use of monoamine oxidase inhibitors in the last two weeks before surgery - Alcohol or drug abuse - Renal dysfunction (GFR < 30 or necessity of dialysis) - Liver Dysfunction defined as Child-Pugh-Score 7-15 - Ejection fraction (EF< 40%) - Malabsorption syndrome - Neurologic or cognitive dysfunction - Pregnancy - Participation in another clinical trial - Severe respiratory depression with hypoxia and/or hypercapnia - Severe chronic obstructive pulmonary disease - Severe bronchial asthma - Non-opioid induced paralytic ileus - Risk of seizures |
Outcome
Primary Outcome Measures
1. total opioid dosage in terms of so-called morphine equivalents [3 days]
Secondary Outcome Measures
1. VAS pain score [3 days]
2. level of sedation [3 days]
3. rate of spontaneous breathing [3 days]
4. possible side effects [3 days]
5. in hospital stay [1 month]
6. ICU stay [1 month]