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

This study is currently recruiting participants.

Verified April 2013 by Hamilton Health Sciences Corporation

Sponsor:

Collaborators:

The Hospital for Sick Children

University of Western Ontario, Canada

Information provided by (Responsible Party):

Doron Sommer, Hamilton Health Sciences Corporation

ClinicalTrials.gov Identifier:

NCT01680939

First received: September 4, 2012

Last updated: April 23, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 4, 2012

Last Updated Date

April 23, 2013

Start Date ^ICMJE

May 2012

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Safety will be assessed by comparing changes in respiratory parameters (oxygen saturation and the number of apnea events per night) following adenotonsillectomy.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01680939 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Effectiveness [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
Analgesic effectiveness between treatment groups will be assessed using the visual analog scale and the objective pain scale
Risk Factors [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Pediatric Obstructive Sleep Apnea Syndrome

Intervention ^ICMJE

Drug: Morphine
0.2-0.5 mg/kg PO q4h
Drug: Ibuprofen
10mg/kg PO q6hrs

Study Arm (s)

Experimental: Morphine
Receives morphine for post-surgical pain

Intervention: Drug: Morphine
Experimental: Ibuprofen
Receives ibuprofen for post-surgical pain

Intervention: Drug: Ibuprofen

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Completion Date

Not Provided

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Year to 10 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Lauren Kelly, MSc. BMSc. PHD candidate

(519) 661-2111 ext 83221

lkelly27@uwo.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01680939

Other Study ID Numbers ^ICMJE

OSAS-HHSC2012

Has Data Monitoring Committee

Yes

Responsible Party

Doron Sommer, Hamilton Health Sciences Corporation

Study Sponsor ^ICMJE

Hamilton Health Sciences Corporation

Collaborators ^ICMJE

The Hospital for Sick Children
University of Western Ontario, Canada

Investigators ^ICMJE

Not Provided

Information Provided By

Hamilton Health Sciences Corporation

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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