Status:
COMPLETED
Oral Oxycodone After Major Cardiac Surgery
Lead Sponsor:
Medical University of Vienna
Conditions:
Heart; Dysfunction Postoperative, Cardiac Surgery
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
Postoperative pain and analgesic treatment still remains a challenge in daily perioperative medicine. Skin incisions, intraoperative tissue retraction and -dissection, intravasal cannulations and drai...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01816581
Start Date
July 1 2011
End Date
March 1 2013
Last Update
March 26 2014
Active Locations (1)
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1
Medical University Vienna
Vienna, Vienna, Austria, 1090