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

This study is currently recruiting participants. (see Contacts and Locations)
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

September 4, 2012
May 24, 2013
May 2012
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01680939 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Investigating the Safety of Post-surgical Analgesics in Children With Obstructive Sleep Apnea
Investigating the Safety of Morphine and Ibuprofen in Children Post-adenotonsillectomy for Obstructive Sleep Apnea

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pediatric Obstructive Sleep Apnea Syndrome
  • Drug: Morphine
    0.2-0.5 mg/kg PO q4h
  • Drug: Ibuprofen
    10mg/kg PO q6hrs
  • Experimental: Morphine
    Receives morphine for post-surgical pain
    Intervention: Drug: Morphine
  • Experimental: Ibuprofen
    Receives ibuprofen for post-surgical pain
    Intervention: Drug: Ibuprofen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
December 2013   (final data collection date for primary outcome measure)

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
Both
1 Year to 10 Years
Yes
Contact: Lauren Kelly, MSc. BMSc. PHD candidate (519) 661-2111 ext 83221 lkelly27@uwo.ca
Canada
 
NCT01680939
OSAS-HHSC2012
Yes
Doron Sommer, Hamilton Health Sciences Corporation
Hamilton Health Sciences Corporation
  • The Hospital for Sick Children
  • University of Western Ontario, Canada
Not Provided
Hamilton Health Sciences Corporation
May 2013

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