NCT01680939

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 1 Year – 10 Years
• Healthy volunteers: Accepted

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

Conditions

• Pediatric Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
DRUG	Morphine	0.2-0.5 mg/kg PO q4h
DRUG	Ibuprofen	10mg/kg PO q6hrs

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-12-01
• First posted: 2012-09-07
• Last updated: 2013-05-27

Locations

1 site across 1 country: Canada