Recruiting
Phase 3

Analgesics

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT01680939

Conditions

Pediatric Obstructive Sleep Apnea Syndrome

Eligibility Criteria

Sex: All

Age: 1 - 10

Healthy Volunteers: Accepted

Interventions

Morphine

Ibuprofen

Study Details

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

Conditions

Pediatric Obstructive Sleep Apnea Syndrome

Study ID

NCT01680939

Start date

May, 2012

Status verified date

May, 2013

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 10

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Morphine

Receives morphine for post-surgical pain

experimental: Ibuprofen

Receives ibuprofen for post-surgical pain

Interventions

Morphine

0.2-0.5 mg/kg PO q4h

Ibuprofen

10mg/kg PO q6hrs

Primary outcome measure

  • Safety [ Time Frame: 1.5 years ]

Central Contacts and Locations

Central contacts

Lauren Kelly, MSc. BMSc. PHD candidate

(519) 661-2111lkelly27@uwo.ca

Locations

McMaster University Medical Centre

Recruiting

Hamilton, Ontario, Canada, L8N3Z5

Principal Investigator:

Doron Sommer, MD FRCSC

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

May 27, 2013

Last verified

May, 2013

Keywords

  • Pediatrics
  • Obstructive Sleep Apnea
  • Adenotonsillectomy
  • Analgesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2013-05-27.