Investigating the Safety of Post-surgical Analgesics in Children With Obstructive Sleep Apnea
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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
Phase:
Phase 3
Details
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborators:
The Hospital for Sick Children University of Western Ontario, Canada