A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery
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Purpose
The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. The hypothesis is that the duration of opioid-induced bowel dysfunction and the need of laxatives will decrease.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Pain Opioid Related Disorders |
Drug: Oxycodone Drug: Prolonged-release oxycodone/naloxone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery |
- Duration of opioid-induced bowel dysfunction postoperatively [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ] [ Designated as safety issue: Yes ]
- Need of laxatives postoperatively [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ] [ Designated as safety issue: No ]
| Enrollment: | 165 |
| Study Start Date: | July 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Oxycodone
Drug: prolonged-release oxycodone
|
Drug: Oxycodone
Prolonged-release oxycodone 10-30 mg twice daily
|
|
Active Comparator: Oxycodone/naloxone
Prolonged-release oxycodone/naloxone
|
Drug: Prolonged-release oxycodone/naloxone
Prolonged-release oxycodone/naloxone 10-30 mg twice daily
|
Detailed Description:
Opioid-induced bowel dysfunction is common in cardiac surgery patients postoperatively. Opioids are needed to treat severe postoperative pain, but they have troublesome side-effects such as nausea, vomiting and bowel dysfunction. These symptoms also limit the use of gastrointestinal tract for nutrition and medication. Combined prolonged-releases oxycodone and naloxone has been shown to provide as effective analgesia as PR oxycodone. Oxycodone/naloxone has also been suggested to improve bowel function without compromising analgesic efficacy.
The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. During the first three months of the study, all cardiac surgery patients will be treated with PR oxycodone. During the second part of the study (3 months), all cardiac surgery patients will be treated with PR oxycodone/naloxone. The primary end point is the duration of opioid-induced bowel dysfunction. Need of laxatives will be recorded.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult cardiac surgery patient
Exclusion Criteria:
- Preoperative continuous use of laxatives
- Known anatomic or functional gastrointestinal disorder
Contacts and Locations| Finland | |
| Tampere University Hospital Heart Center | |
| Tampere, Finland, 33521 | |
| Principal Investigator: | Kati Järvelä, MD, PhD | Tampere University Hospital Heart Center |
More Information
No publications provided
| Responsible Party: | Kati Järvelä, MD, PhD, Tampere University Hospital |
| ClinicalTrials.gov Identifier: | NCT01374763 History of Changes |
| Other Study ID Numbers: | R10133M, 2010-023025-37 |
| Study First Received: | May 26, 2011 |
| Last Updated: | February 17, 2012 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by Tampere University Hospital:
|
Naloxone Oxycodone Constipation |
Pain, postoperative Physiological effects of drugs Analgesics, Opioid |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Pain, Postoperative Substance-Related Disorders Mental Disorders Postoperative Complications Pathologic Processes Pain Signs and Symptoms Naloxone Oxycodone Physiological Effects of Drugs |
Narcotic Antagonists Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Narcotics Central Nervous System Depressants Analgesics Analgesics, Opioid |
ClinicalTrials.gov processed this record on June 18, 2013