Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-08-31

Brief Summary

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To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus Injection of Dexmedetomidine.

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Detailed Description

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Conditions

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Tonsillectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexmedetomidine

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery

placebo

Normal saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Dexmedetomidine

0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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Precedex

Eligibility Criteria

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Inclusion Criteria

* children undergoing tonsillectomy with and without adenoidectomy and myringotomy and tube insertion
* ASA 1,2,3
* females who have started menses but have a negative urine pregnancy test

Exclusion Criteria

* patients with known dysrhythmias,
* not recovering in the ICU
* developmental delay,
* autism communication disorder
* bleeding disorder
* PI discretion

Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No