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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-05-03

Brief Summary

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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.

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Detailed Description

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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

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketamine infusion

Ketamine infusion at 0.1 mg/kg/hr up to maximum of 10 mg/hr

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Post-operative continuous infusion until 0600 the next day

Saline infusion

Group Type PLACEBO_COMPARATOR

Saline infusion

Intervention Type OTHER

Post-operative continuous infusion until 0600 the next day

Interventions

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Ketamine

Post-operative continuous infusion until 0600 the next day

Intervention Type DRUG

Saline infusion

Post-operative continuous infusion until 0600 the next day

Intervention Type OTHER

Other Intervention Names

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Ketalar Placebo comparator

Eligibility Criteria

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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..

Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes