NCT01374763

A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Kati Järvelä · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pain
• Opioid Related Disorders

Interventions

Type	Name	Description
DRUG	Oxycodone	Prolonged-release oxycodone 10-30 mg twice daily
DRUG	Prolonged-release oxycodone/naloxone	Prolonged-release oxycodone/naloxone 10-30 mg twice daily

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-06-16
• Last updated: 2012-02-20

Locations

1 site across 1 country: Finland