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

Information source: Hamilton Health Sciences Corporation
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pediatric Obstructive Sleep Apnea Syndrome

Intervention: Morphine (Drug); Ibuprofen (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hamilton Health Sciences Corporation

Overall contact:
Lauren Kelly, MSc. BMSc. PHD candidate, Phone: (519) 661-2111, Ext: 83221, Email: lkelly27@uwo.ca

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety

Secondary outcome:

Effectiveness

Risk Factors

Eligibility

Minimum age: 1 Year. Maximum age: 10 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Lauren Kelly, MSc. BMSc. PHD candidate, Phone: (519) 661-2111, Ext: 83221, Email: lkelly27@uwo.ca

McMaster University Medical Centre, Hamilton, Ontario L8N3Z5, Canada; Recruiting
Doron Sommer, MD
Doron Sommer, MD FRCSC, Principal Investigator
Additional Information

Starting date: May 2012
Last updated: May 24, 2013

Page last updated: August 20, 2015

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