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

Phase 4

Completed

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Other: Saline infusion; Drug: Ketamine

• Registration Number: NCT02425202
• Lead Sponsor: University of Manitoba

Brief 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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-23
• Status Verified: 2018-05
• Primary Completion: 2018-05-03
• Study Completion: 2018-05-03
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Patients requiring tonsillectomy for diagnosis of sleep disordered breathing/obstructive sleep apnea that will be admitted for overnight cardiorespiratory monitoring, based on positive polysomnography test, positive nocturnal home oximetry, or strong signs/symptoms of OSAS

Exclusion Criteria

• Patients with significant developmental delay, abnormal airway anatomy, significant co-morbidities such as cardiac disorders, respiratory disorders, neurological disorders, anad renal disorders.
• Previous reaction to study medications.
• Postoperative bleeding within the first 24 hours
• Refusal to be involved in the study..

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline infusion	Saline infusion	Saline infusion
Ketamine infusion	Ketamine	Ketamine infusion at 0.1 mg/kg/hr up to maximum of 10 mg/hr

Primary Outcome Measures

Name	Time	Method
Measurement of post-operative opioid requirements after tonsillectomy in obstructive sleep apnea (OSA) patients	24 hrs	Influence of low-dose continuous ketamine infusion on post-operative opioid requirements after tonsillectomy in OSA patients.

Secondary Outcome Measures

Name	Time	Method
Documentation of respiratory morbidity after tonsillectomy in OSA patients	24 hrs	Influence of low-dose ketamine infusion on respiratory morbidity after tonsillectomy in OSA patients

Trial Locations

Locations (1)

Health Sciences Center; 🇨🇦 Winnipeg, Manitoba, Canada