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

Sponsor

Hamilton Health Sciences Corporation (Other)

Overall Status

Unknown status

CT.gov ID

NCT01680939

Collaborator

The Hospital for Sick Children (Other), University of Western Ontario, Canada (Other)

120

Enrollment

Location

Arms

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pediatric Obstructive Sleep Apnea Syndrome	Drug: Morphine Drug: Ibuprofen	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Morphine Receives morphine for post-surgical pain	Drug: Morphine 0.2-0.5 mg/kg PO q4h
Experimental: Ibuprofen Receives ibuprofen for post-surgical pain	Drug: Ibuprofen 10mg/kg PO q6hrs

Arm

Intervention/Treatment

Experimental: Morphine

Receives morphine for post-surgical pain

Drug: Morphine

0.2-0.5 mg/kg PO q4h

Experimental: Ibuprofen

Receives ibuprofen for post-surgical pain

Drug: Ibuprofen

10mg/kg PO q6hrs

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.