Dexmedetomidine in Children Having Transthoracic Echocardiography

Study Overview
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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).

Official Title
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A Qualitative Comparison of Oral Chloral Hydrate vs 2.0 or 3.0 mcg/kg Nasal Dexmedetomidine in Children Undergoing Transthoracic Echocardiography

Conditions
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Heart Disease

Intervention / Treatment
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* Drug: Chloral Hydrate
* Drug: Dexmedetomidine
* Drug: Dexmedetomidine
* Drug: Placebo


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chloral Hydrate + placebo<br>Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo | Drug: Chloral Hydrate<br>* 70mg/kg chloral hydrate<br>Drug: Placebo<br>* Flavored placebo syrup<br>|
| Active Comparator: Dexmedetomidine 2mcg/kg + placebo<br>Nasal dexmedetomidine sedation 2 mcg/kg plus oral flavored syrup placebo | Drug: Dexmedetomidine<br>* 2mcg/kg<br>Drug: Placebo<br>* Flavored placebo syrup<br>|
| Active Comparator: Dexmedetomidine 3mcg/kg + placebo<br>Nasal dexmedetomidine sedation 3 mcg/kg plus oral flavored syrup placebo | Drug: Dexmedetomidine<br>* 3mcg/kg<br>Drug: Placebo<br>* Flavored placebo syrup<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to sedation | Achieve Ramsay sedation >3 within 30 minutes of administration of drug | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of sedation level >3 |  | Patients will be followed for the duration of the procedure, average of 1 hour | 
| The number of sonographer pauses | The number of sonographer pauses over 2 minutes due to patient movement or medical interventions will be counted | Participants will be followed for the duration of the procedure, average of 1 hour | 
| Need for rescue dexmedetomidine | The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE. | Participants will be followed for the duration of the procedure, average of 1 hour | 
| Incidence of respiratory complications | Documentation of the incidence of respiratory complications | Participants will be followed for the duration of the hospital stay, average of 2 hours | 
| Vital sign deviations of more than 30% from baseline | Documentation of the incidence of blood pressure or heart rate deviations of more than 30% from baseline. Baseline will be measured prior to sedative administration. | Participants will be followed for the duration of the hospital stay, average of 2 hours | 
| Post anesthesia drowsiness | Documentation of the incidence of post anesthesia drowsiness | Participants will be followed for the duration of the post procedure stay, average of 1 hour | 
| Duration of Post Anesthesia Care Unit phase | Documentation of the stay in Post Anesthesia Care Unit in minutes | Participants will be followed for the duration of the post procedure stay, average of 1 hour | 
| Time to oral fluid intake | Documentation of the time (in minutes) to oral fluid intake during the PACU phase | Participants will be followed for the duration of the post procedure stay, average of 1 hour | 
| Time to discharge | Documentation of the hospital stay after completion of the TTE. | Participants will be followed for the duration of the post procedure stay, average of 1 hour | 
| Satisfaction of parents | The satisfaction of the sedation technique will be completed by the parents by asking a series of questions during a follow-up phone call the next business day after the TTE. | Up to 3 days | 
| Severity of respiratory complications | Documentation of the severity of respiratory complications | Participants will be followed for the duration of the hospital stay, average of 2 hours | 
| Post anesthesia agitation | Documentation of the incidence of post anesthesia agitation | Participants will be followed for the duration of the post procedure stay, average of 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transthoracic echocardiography, echo, TTE