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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kati Järvelä, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01374763
First received: May 26, 2011
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Opioid Related Disorders
Drug: Oxycodone
Drug: Prolonged-release oxycodone/naloxone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Need of laxatives postoperatively [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxycodone
Drug: prolonged-release oxycodone
Drug: Oxycodone
Prolonged-release oxycodone 10-30 mg twice daily
Active Comparator: Oxycodone/naloxone
Prolonged-release oxycodone/naloxone
Drug: Prolonged-release oxycodone/naloxone
Prolonged-release oxycodone/naloxone 10-30 mg twice daily

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult cardiac surgery patient

Exclusion Criteria:

  • Preoperative continuous use of laxatives
  • Known anatomic or functional gastrointestinal disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374763

Locations
Finland
Tampere University Hospital Heart Center
Tampere, Finland, 33521
Sponsors and Collaborators
Kati Järvelä
Investigators
Principal Investigator: Kati Järvelä, MD, PhD Tampere University Hospital Heart Center
  More Information

No publications provided

Responsible Party: Kati Järvelä, MD, PhD, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01374763     History of Changes
Other Study ID Numbers: R10133M, 2010-023025-37
Study First Received: May 26, 2011
Last Updated: February 17, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Tampere University Hospital:
Naloxone
Oxycodone
Constipation
Pain, postoperative
Physiological effects of drugs
Analgesics, Opioid

Additional relevant MeSH terms:
Pain, Postoperative
Opioid-Related Disorders
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Oxycodone
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 18, 2014