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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374763
• Other study ID #: R10133M
• Secondary ID: 2010-023025-37
• Status: Completed
• Phase: Phase 4
• First received: May 26, 2011
• Last updated: February 17, 2012
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult cardiac surgery patient

Exclusion Criteria:

• Preoperative continuous use of laxatives

• Known anatomic or functional gastrointestinal disorder

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Related Disorders
• Opioid-Related Disorders
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Oxycodone
Prolonged-release oxycodone 10-30 mg twice daily
• Prolonged-release oxycodone/naloxone
Prolonged-release oxycodone/naloxone 10-30 mg twice daily

Locations

Country	Name	City	State
Finland	Tampere University Hospital Heart Center	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Kati Järvelä

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of opioid-induced bowel dysfunction postoperatively		Participants will be followed for the duration of hospital stay, an expected average of 5 days	Yes
Secondary	Need of laxatives postoperatively		Participants will be followed for the duration of hospital stay, an expected average of 5 days	No