Investigating the Safety of Post-surgical Analgesics in Children With Obstructive Sleep Apnea
|ClinicalTrials.gov Identifier: NCT01680939|
Recruitment Status : Unknown
Verified May 2013 by Doron Sommer, Hamilton Health Sciences Corporation.
Recruitment status was: Recruiting
First Posted : September 7, 2012
Last Update Posted : May 27, 2013
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
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Obstructive Sleep Apnea Syndrome||Drug: Morphine Drug: Ibuprofen||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigating the Safety of Morphine and Ibuprofen in Children Post-adenotonsillectomy for Obstructive Sleep Apnea|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||December 2013|
Receives morphine for post-surgical pain
0.2-0.5 mg/kg PO q4h
Receives ibuprofen for post-surgical pain
10mg/kg PO q6hrs
- 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.
- Effectiveness [ Time Frame: 1.5 years ]Analgesic effectiveness between treatment groups will be assessed using the visual analog scale and the objective pain scale
- Risk Factors [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680939
|Contact: Lauren Kelly, MSc. BMSc. PHD candidate||(519) 661-2111 ext firstname.lastname@example.org|
|McMaster University Medical Centre||Recruiting|
|Hamilton, Ontario, Canada, L8N3Z5|
|Contact: Doron Sommer, MD|
|Principal Investigator: Doron Sommer, MD FRCSC|