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

Primary Purpose

Pediatric Obstructive Sleep Apnea Syndrome

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Morphine
Ibuprofen
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obstructive Sleep Apnea Syndrome focused on measuring Pediatrics, Obstructive Sleep Apnea, Adenotonsillectomy, Analgesia

Eligibility Criteria

1 Year - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • McMaster University Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Morphine

Ibuprofen

Arm Description

Receives morphine for post-surgical pain

Receives ibuprofen for post-surgical pain

Outcomes

Primary Outcome Measures

Safety
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
Analgesic effectiveness between treatment groups will be assessed using the visual analog scale and the objective pain scale
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.

Full Information

First Posted
September 4, 2012
Last Updated
May 24, 2013
Sponsor
Hamilton Health Sciences Corporation
Collaborators
The Hospital for Sick Children, University of Western Ontario, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01680939
Brief Title
Investigating the Safety of Post-surgical Analgesics in Children With Obstructive Sleep Apnea
Official Title
Investigating the Safety of Morphine and Ibuprofen in Children Post-adenotonsillectomy for Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
The Hospital for Sick Children, University of Western Ontario, Canada

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obstructive Sleep Apnea Syndrome
Keywords
Pediatrics, Obstructive Sleep Apnea, Adenotonsillectomy, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Morphine
Arm Type
Experimental
Arm Description
Receives morphine for post-surgical pain
Arm Title
Ibuprofen
Arm Type
Experimental
Arm Description
Receives ibuprofen for post-surgical pain
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
0.2-0.5 mg/kg PO q4h
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
10mg/kg PO q6hrs
Primary Outcome Measure Information:
Title
Safety
Description
Safety will be assessed by comparing changes in respiratory parameters (oxygen saturation and the number of apnea events per night) following adenotonsillectomy.
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
Effectiveness
Description
Analgesic effectiveness between treatment groups will be assessed using the visual analog scale and the objective pain scale
Time Frame
1.5 years
Title
Risk Factors
Description
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.
Time Frame
1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Kelly, MSc. BMSc. PHD candidate
Phone
(519) 661-2111
Ext
83221
Email
lkelly27@uwo.ca
Facility Information:
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doron Sommer, MD
First Name & Middle Initial & Last Name & Degree
Doron Sommer, MD FRCSC

12. IPD Sharing Statement

Citations:
PubMed Identifier
25624387
Citation
Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.
Results Reference
derived

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

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