A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery
NCT ID: NCT01374763
Last Updated: 2012-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
165 participants
INTERVENTIONAL
2011-07-31
2011-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Oxycodone
Drug: prolonged-release oxycodone
Oxycodone
Prolonged-release oxycodone 10-30 mg twice daily
Oxycodone/naloxone
Prolonged-release oxycodone/naloxone
Prolonged-release oxycodone/naloxone
Prolonged-release oxycodone/naloxone 10-30 mg twice daily
Interventions
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Oxycodone
Prolonged-release oxycodone 10-30 mg twice daily
Prolonged-release oxycodone/naloxone
Prolonged-release oxycodone/naloxone 10-30 mg twice daily
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Known anatomic or functional gastrointestinal disorder
18 Years
ALL
No
Sponsors
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Kati Järvelä
OTHER
Responsible Party
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Kati Järvelä
MD, PhD
Principal Investigators
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Kati Järvelä, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tampere University Hospital Heart Center
Locations
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Tampere University Hospital Heart Center
Tampere, , Finland
Countries
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Other Identifiers
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2010-023025-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R10133M
Identifier Type: -
Identifier Source: org_study_id
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