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

This study is currently recruiting participants.
Verified May 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: May 24, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Pediatric Obstructive Sleep Apnea Syndrome
Drug: Morphine
Drug: Ibuprofen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigating the Safety of Morphine and Ibuprofen in Children Post-adenotonsillectomy for Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Hamilton Health Sciences Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: May 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680939

Contacts
Contact: Lauren Kelly, MSc. BMSc. PHD candidate (519) 661-2111 ext 83221 lkelly27@uwo.ca

Locations
Canada, Ontario
McMaster University Medical Centre Recruiting
Hamilton, Ontario, Canada, L8N3Z5
Contact: Doron Sommer, MD         
Principal Investigator: Doron Sommer, MD FRCSC         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
The Hospital for Sick Children
University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Doron Sommer, MD, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT01680939     History of Changes
Other Study ID Numbers: OSAS-HHSC2012
Study First Received: September 4, 2012
Last Updated: May 24, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Hamilton Health Sciences Corporation:
Pediatrics
Obstructive Sleep Apnea
Adenotonsillectomy
Analgesia

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Ibuprofen
Morphine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Analgesics, Opioid
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 15, 2014