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

Study Overview
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Brief Summary
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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

Official Title
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Investigating the Safety of Morphine and Ibuprofen in Children Post-adenotonsillectomy for Obstructive Sleep Apnea

Conditions
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Pediatric Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Drug: Morphine
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morphine<br>Receives morphine for post-surgical pain | Drug: Morphine<br>* 0.2-0.5 mg/kg PO q4h<br>|
| Experimental: Ibuprofen<br>Receives ibuprofen for post-surgical pain | Drug: Ibuprofen<br>* 10mg/kg PO q6hrs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | Analgesic effectiveness between treatment groups will be assessed using the visual analog scale and the objective pain scale | 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. | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Obstructive Sleep Apnea, Adenotonsillectomy, Analgesia