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

Phase 3

• Conditions: Pediatric Obstructive Sleep Apnea Syndrome
• Interventions: Drug: Morphine; Drug: Ibuprofen

• Registration Number: NCT01680939
• Lead Sponsor: Hamilton Health Sciences Corporation

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-07
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-24
• Last Update Posted: 2013-05-27
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Morphine	Morphine	Receives morphine for post-surgical pain
Ibuprofen	Ibuprofen	Receives ibuprofen for post-surgical pain

Primary Outcome Measures

Name	Time	Method
Safety	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 Outcome Measures

Name	Time	Method
Effectiveness	1.5 years	Analgesic effectiveness between treatment groups will be assessed using the visual analog scale and the objective pain scale
Risk Factors	1.5 years	Age, BMI, OSA severity and genetic factors will be compared between treatment groups. Furthermore, these factors will be isolated to determine any correlation exists with respiratory parameter improvement in all enrolled patients.

Trial Locations

Locations (1)

McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada