We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01680939
Recruitment Status : Unknown
Verified May 2013 by Doron Sommer, Hamilton Health Sciences Corporation.
Recruitment status was:  Recruiting
First Posted : September 7, 2012
Last Update Posted : May 27, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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  (Clinical Trial)
Estimated 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 2012
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. Safety [ Time Frame: 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 :
  1. Effectiveness [ Time Frame: 1.5 years ]
    Analgesic effectiveness between treatment groups will be assessed using the visual analog scale and the objective pain scale

  2. Risk Factors [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Doron Sommer, MD, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT01680939     History of Changes
Other Study ID Numbers: OSAS-HHSC2012
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013

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

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