Pediatric Obstructive Sleep Apnea Syndrome
Conditions
Keywords
Pediatrics, Obstructive Sleep Apnea, Adenotonsillectomy, Analgesia
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
Interventions
DRUGMorphine
0.2-0.5 mg/kg PO q4h
DRUGIbuprofen
10mg/kg PO q6hrs
Sponsors
The Hospital for Sick Children
University of Western Ontario, Canada
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Contacts
Primary ContactLauren Kelly, MSc. BMSc. PHD candidate
Outcome results
None listed