NCT02425202

Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome (OSAS) After Tonsillectomy

Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome After Tonsillectomy: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the post-operative morphine-sparing effect, pain reduction, and side effects of a continuous ketamine infusion after tonsillectomy in pediatric patients.

Detailed description

Eligible pediatric patients that are undergoing tonsillectomy for sleep-disordered breathing or obstructive sleep apnea AND are to be admitted into a monitored setting will be recruited for this study. They will be randomized into two groups:1) Control group receiving continuous infusion of saline (placebo) and 2) Study group receiving continuous infusion of low-dose ketamine at 0.1 mg/kg/hr. Both patients will receive scheduled oral acetaminophen and rescue intravenous morphine as required. The infusions will be stopped at 0600 the next morning. Morphine requirements, pain scores at selected times, central nervous system side effects, and adverse cardiorespiratory events will be recorded.

Conditions

• Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
DRUG	Ketamine	Post-operative continuous infusion until 0600 the next day
OTHER	Saline infusion	Post-operative continuous infusion until 0600 the next day

Timeline

• Start date: 2014-12-01
• Primary completion: 2018-05-03
• Completion: 2018-05-03
• First posted: 2015-04-23
• Last updated: 2018-10-15

Locations

1 site across 1 country: Canada