Dexmedetomidine in Children Having Transthoracic Echocardiography

Cincinnati Children's Hospital Medical Center

Status and phase: Completed; Phase 4

Conditions: Heart Disease

Treatments: Drug: Dexmedetomidine; Drug: Placebo; Drug: Chloral Hydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02523144

SCMCIRB-K2014057

Details and patient eligibility

About

Sedation Techniques for children undergoing transthoracic echocardiography (TTE).

Full description

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).

Enrollment: 279 patients

Sex: All

Ages: 3 to 36 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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279 participants in 3 patient groups

Chloral Hydrate + placebo

Active Comparator group

Description:

Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo

Treatment:

Drug: Placebo

Drug: Chloral Hydrate

Dexmedetomidine 2mcg/kg + placebo

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

Drug: Placebo

Drug: Dexmedetomidine

Dexmedetomidine 3mcg/kg + placebo

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

Drug: Placebo

Drug: Dexmedetomidine