Investigating the Safety of Post-surgical Analgesics in Children With Obstructive Sleep Apnea
Information source: Hamilton Health Sciences Corporation
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pediatric Obstructive Sleep Apnea Syndrome
Intervention: Morphine (Drug); Ibuprofen (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Hamilton Health Sciences Corporation Overall contact: Lauren Kelly, MSc. BMSc. PHD candidate, Phone: (519) 661-2111, Ext: 83221, Email: lkelly27@uwo.ca
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
Clinical Details
Official title: Investigating the Safety of Morphine and Ibuprofen in Children Post-adenotonsillectomy for Obstructive Sleep Apnea
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Safety
Secondary outcome: EffectivenessRisk Factors
Eligibility
Minimum age: 1 Year.
Maximum age: 10 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- diagnosed with OSAS,
- scheduled for tonsillectomy plus/minus adenoid removal at MUMC,
- between the ages of 1-10years
Exclusion Criteria:
- contraindications to analgesia,
- asthma,
- has had previous adenotonsillectomy, or
- any craniofacial,
- neuromuscular or cardiac conditions
Locations and Contacts
Lauren Kelly, MSc. BMSc. PHD candidate, Phone: (519) 661-2111, Ext: 83221, Email: lkelly27@uwo.ca
McMaster University Medical Centre, Hamilton, Ontario L8N3Z5, Canada; Recruiting Doron Sommer, MD Doron Sommer, MD FRCSC, Principal Investigator
Additional Information
Starting date: May 2012
Last updated: May 24, 2013
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