A Phase 3 interventional study of Morphine and Ibuprofen in Pediatric Obstructive Sleep Apnea Syndrome, sponsored by Hamilton Health Sciences Corporation. Status unknown at 1 site in Canada. Open to participants aged 1 Year to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-27.
Sponsored by Hamilton Health Sciences Corporation · Phase 3, Interventional, and Treatment
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
1,423 studies on the registry are indexed under Apnea; 160 are open to participants now.
This study's planned enrollment of 120 is above the median of 51 across 966 interventional studies indexed under Apnea.
Browse Apnea studies →Hamilton Health Sciences Corporation is the lead sponsor of 237 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Receives morphine for post-surgical pain
Drug: Morphine
Receives ibuprofen for post-surgical pain
Drug: Ibuprofen
0.2-0.5 mg/kg PO q4h
10mg/kg PO q6hrs
Safety
Safety will be assessed by comparing changes in respiratory parameters (oxygen saturation and the number of apnea events per night) following adenotonsillectomy.
Time frame: 1.5 years
Effectiveness
Analgesic effectiveness between treatment groups will be assessed using the visual analog scale and the objective pain scale
Time frame: 1.5 years
Risk Factors
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.
Time frame: 1.5 years
This study is status unknown, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Hamilton Health Sciences Corporation