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

Hamilton Health Sciences (HHS)

Status and phase: Unknown; Phase 3

Conditions: Pediatric Obstructive Sleep Apnea Syndrome

Treatments: Drug: Ibuprofen; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT01680939

OSAS-HHSC2012

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 1 to 10 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Morphine

Experimental group

Description:

Receives morphine for post-surgical pain

Treatment:

Drug: Morphine

Ibuprofen

Experimental group

Description:

Receives ibuprofen for post-surgical pain

Treatment:

Drug: Ibuprofen