A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery
Overview
- Phase
- Phase 4
- Intervention
- Oxycodone
- Conditions
- Postoperative Pain
- Sponsor
- Kati Järvelä
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- Duration of opioid-induced bowel dysfunction postoperatively
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Kati Järvelä
MD, PhD
Tampere University Hospital
Eligibility Criteria
Inclusion Criteria
- •Adult cardiac surgery patient
Exclusion Criteria
- •Preoperative continuous use of laxatives
- •Known anatomic or functional gastrointestinal disorder
Arms & Interventions
Oxycodone
Drug: prolonged-release oxycodone
Intervention: Oxycodone
Oxycodone/naloxone
Prolonged-release oxycodone/naloxone
Intervention: Prolonged-release oxycodone/naloxone
Outcomes
Primary Outcomes
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 Outcomes
- Need of laxatives postoperatively(Participants will be followed for the duration of hospital stay, an expected average of 5 days)