Investigating the Safety of Post-surgical Analgesics in Children With Obstructive Sleep Apnea

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborators: The Hospital for Sick Children; University of Western Ontario, Canada
• Treatments: Ibuprofen; Morphine

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