Back to resultsA Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery
Primary Purpose
Postoperative Pain, Opioid Related Disorders
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Oxycodone
Prolonged-release oxycodone/naloxone
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Naloxone, Oxycodone, Constipation, Pain, postoperative, Physiological effects of drugs, Analgesics, Opioid
Eligibility Criteria
Inclusion Criteria:
- Adult cardiac surgery patient
Exclusion Criteria:
- Preoperative continuous use of laxatives
- Known anatomic or functional gastrointestinal disorder
Sites / Locations
- Tampere University Hospital Heart Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oxycodone
Oxycodone/naloxone
Arm Description
Drug: prolonged-release oxycodone
Prolonged-release oxycodone/naloxone
Outcomes
Primary Outcome Measures
Duration of opioid-induced bowel dysfunction postoperatively
Secondary Outcome Measures
Need of laxatives postoperatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01374763
Brief Title
A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery
Official Title
A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kati Järvelä
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Opioid Related Disorders
Keywords
Naloxone, Oxycodone, Constipation, Pain, postoperative, Physiological effects of drugs, Analgesics, Opioid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxycodone
Arm Type
Active Comparator
Arm Description
Drug: prolonged-release oxycodone
Arm Title
Oxycodone/naloxone
Arm Type
Active Comparator
Arm Description
Prolonged-release oxycodone/naloxone
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Prolonged-release oxycodone 10-30 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Prolonged-release oxycodone/naloxone
Intervention Description
Prolonged-release oxycodone/naloxone 10-30 mg twice daily
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Need of laxatives postoperatively
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult cardiac surgery patient
Exclusion Criteria:
Preoperative continuous use of laxatives
Known anatomic or functional gastrointestinal disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kati Järvelä, MD, PhD
Organizational Affiliation
Tampere University Hospital Heart Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital Heart Center
City
Tampere
ZIP/Postal Code
33521
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery
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