Investigating the Safety of Morphine and Ibuprofen in Children Post-adenotonsillectomy for Obstructive Sleep Apnea
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Safety
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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,
- •has had previous adenotonsillectomy, or
- •any craniofacial,
- •neuromuscular or cardiac conditions
Arms & Interventions
Morphine
Receives morphine for post-surgical pain
Intervention: Morphine (Drug)
Ibuprofen
Receives ibuprofen for post-surgical pain
Intervention: Ibuprofen (Drug)
Outcomes
Primary Outcomes
Safety
Time Frame: 1.5 years
Safety will be assessed by comparing changes in respiratory parameters (oxygen saturation and the number of apnea events per night) following adenotonsillectomy.
Secondary Outcomes
- Effectiveness(1.5 years)
- Risk Factors(1.5 years)
Investigators
Doron Sommer
MD
Hamilton Health Sciences Corporation