Pediatric Obstructive Sleep Apnea Syndrome Clinical Trial
Official title:
Investigating the Safety of Morphine and Ibuprofen in Children Post-adenotonsillectomy for Obstructive Sleep Apnea
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
| Status | Unknown status |
| Enrollment | 120 |
| Est. completion date | |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 1 Year to 10 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | McMaster University Medical Centre | Hamilton | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Hamilton Health Sciences Corporation | The Hospital for Sick Children, University of Western Ontario, Canada |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety | Safety will be assessed by comparing changes in respiratory parameters (oxygen saturation and the number of apnea events per night) following adenotonsillectomy. | 1.5 years | |
| Secondary | Effectiveness | Analgesic effectiveness between treatment groups will be assessed using the visual analog scale and the objective pain scale | 1.5 years | |
| Secondary | 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. | 1.5 years |