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Dexmedetomidine in Children Having Transthoracic Echocardiography

NCT ID: NCT02523144

Last Updated: 2017-07-31

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

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-05-31

Brief Summary

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Sedation Techniques for children undergoing transthoracic echocardiography (TTE).

Detailed Description

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The goal in this study is to determine if there is a significant difference in the quality of sedation between two standard sedation techniques and between two doses of dexmedetomidine for children undergoing (TTE).

Conditions

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Heart Disease

Keywords

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Transthoracic echocardiography echo TTE

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Chloral Hydrate + placebo

Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo

Group Type ACTIVE_COMPARATOR

Chloral Hydrate

Intervention Type DRUG

70mg/kg chloral hydrate

Placebo

Intervention Type DRUG

Flavored placebo syrup

Dexmedetomidine 2mcg/kg + placebo

Nasal dexmedetomidine sedation 2 mcg/kg plus oral flavored syrup placebo

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

2mcg/kg

Placebo

Intervention Type DRUG

Flavored placebo syrup

Dexmedetomidine 3mcg/kg + placebo

Nasal dexmedetomidine sedation 3 mcg/kg plus oral flavored syrup placebo

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

3mcg/kg

Placebo

Intervention Type DRUG

Flavored placebo syrup

Interventions

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Chloral Hydrate

70mg/kg chloral hydrate

Intervention Type DRUG

Dexmedetomidine

2mcg/kg

Intervention Type DRUG

Dexmedetomidine

3mcg/kg

Intervention Type DRUG

Placebo

Flavored placebo syrup

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients scheduled to receive sedation for transthoracic echocardiography
* Subject must be a candidate for both types of anesthetic and both doses of dexmedetomidine
* Must be 3 months to 36 months of age

Exclusion Criteria

* The subject has a history of cardiac conduction system disease (e.g. 1st or 2nd degree AV block) or channelopathy (e.g. long QT).
* The subject is taking digoxin, alpha-adrenergic or beta-adrenergic agonist or antagonist (e.g., clonidine, propranolol, albuterol), anti-arrhythmic medications, or vasodilators (e.g. ACE inhibitors)
* The subject has received a dose of any other sedative within 48 hours.
* The subject has life-threatening, medical conditions (American Society of Anesthesiologists Physical Status 4, 5). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
* The subject is allergic to or has a contraindication to any of the drugs used in the study.
* The subject has previously been treated under this protocol.
* The subject has severe coarctation of the aorta (risk of exaggerated vasoconstriction)
* The subject has Moyamoya disease (risk of recurrent stroke)
Minimum Eligible Age

3 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Shanghai Children's Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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SCMCIRB-K2014057

Identifier Type: -

Identifier Source: org_study_id