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NCT Number: NCT01374763

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

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.

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Key information

Conditions

Postoperative Pain Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid Related Disorders Opioid-Related Disorders Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tampere University Hospital Heart Center

Tampere, 33521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult cardiac surgery patient

Exclusion criteria

  • Preoperative continuous use of laxatives
  • Known anatomic or functional gastrointestinal disorder

Treatment and study plan

Oxycodone

Drug

Prolonged-release oxycodone 10-30 mg twice daily

Prolonged-release oxycodone/naloxone

Drug

Prolonged-release oxycodone/naloxone 10-30 mg twice daily

Primary outcomes

  1. 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

  1. Need of laxatives postoperatively

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days

Sponsors and collaborators

Lead sponsor

Kati Järvelä

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 16, 2011
Registry last updated
Feb 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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