Investigating the Safety of Post-surgical Analgesics in Children With Obstructive Sleep Apnea
NCT ID: NCT01680939
Last Updated: 2013-05-27
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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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2012-05-31
Brief Summary
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The primary objectives of this study is to assess the safety(1) and efficacy (2) of morphine and ibuprofen in children with sleep apnea.
An interim analysis will be conducted after recruitment of 70 patients, to monitor both safety and efficacy
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Morphine
Receives morphine for post-surgical pain
Morphine
0.2-0.5 mg/kg PO q4h
Ibuprofen
Receives ibuprofen for post-surgical pain
Ibuprofen
10mg/kg PO q6hrs
Interventions
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Morphine
0.2-0.5 mg/kg PO q4h
Ibuprofen
10mg/kg PO q6hrs
Eligibility Criteria
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Inclusion Criteria
* scheduled for tonsillectomy plus/minus adenoid removal at MUMC,
* between the ages of 1-10years
Exclusion Criteria
* asthma,
* has had previous adenotonsillectomy, or
* any craniofacial,
* neuromuscular or cardiac conditions
1 Year
10 Years
ALL
Yes
Sponsors
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The Hospital for Sick Children
OTHER
University of Western Ontario, Canada
OTHER
Hamilton Health Sciences Corporation
OTHER
Responsible Party
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Doron Sommer
MD
Locations
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McMaster University Medical Centre
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Doron Sommer, MD
Role: primary
References
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Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.
Other Identifiers
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OSAS-HHSC2012
Identifier Type: -
Identifier Source: org_study_id
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