Investigating the Safety of Post-surgical Analgesics in Children With Obstructive Sleep Apnea
Investigating the Safety of Morphine and Ibuprofen in Children Post-adenotonsillectomy for Obstructive Sleep Apnea
1 other identifier
interventional
120
1 country
1
Brief Summary
Every year thousands of young children with obstructive sleep apnea undergo surgery which requires them to be prescribed pain medication. The current standard in North America is administration of opioids, mainly codeine or morphine; however in many areas of the world including Canada, nonsteroidal anti-inflammatory medications such as ibuprofen are used. Some North American surgeons are uncertain regarding the potential of ibuprofen to increase bleeding following surgery. The results of research studies have been inconclusive overall. Due to recent codeine fatalities in children following adenotonsillectomy, codeine has been removed from the formulary at many Pediatric institutions. Some surgeons have begun to use oral morphine as an alternate to codeine, which necessitates the need to find safe alternative analgesics in this treatment group. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 4, 2012
CompletedFirst Posted
Study publicly available on registry
September 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedMay 27, 2013
May 1, 2013
1.6 years
September 4, 2012
May 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Safety will be assessed by comparing changes in respiratory parameters (oxygen saturation and the number of apnea events per night) following adenotonsillectomy.
1.5 years
Secondary Outcomes (2)
Effectiveness
1.5 years
Risk Factors
1.5 years
Study Arms (2)
Morphine
EXPERIMENTALReceives morphine for post-surgical pain
Ibuprofen
EXPERIMENTALReceives ibuprofen for post-surgical pain
Interventions
Eligibility Criteria
You may qualify if:
- diagnosed with OSAS,
- scheduled for tonsillectomy plus/minus adenoid removal at MUMC,
- between the ages of 1-10years
You may not qualify if:
- contraindications to analgesia,
- asthma,
- has had previous adenotonsillectomy, or
- any craniofacial,
- neuromuscular or cardiac conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hamilton Health Sciences Corporationlead
- The Hospital for Sick Childrencollaborator
- University of Western Ontario, Canadacollaborator
Study Sites (1)
McMaster University Medical Centre
Hamilton, Ontario, L8N3Z5, Canada
Related Publications (1)
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.
PMID: 25624387DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 4, 2012
First Posted
September 7, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2013
Last Updated
May 27, 2013
Record last verified: 2013-05