Dexmedetomidine in Children Having Transthoracic Echocardiography

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Completed

CT.gov ID

NCT02523144

Collaborator

(none)

279

Enrollment

Location

Arms

Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sedation Techniques for children undergoing transthoracic echocardiography (TTE).

Condition or Disease	Intervention/Treatment	Phase
Heart Disease	Drug: Chloral Hydrate Drug: Dexmedetomidine Drug: Dexmedetomidine Drug: Placebo	Phase 4

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

279 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Chloral Hydrate + placebo

Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo

Drug: Chloral Hydrate

70mg/kg chloral hydrate

Drug: Placebo

Flavored placebo syrup

Active Comparator: Dexmedetomidine 2mcg/kg + placebo

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

Drug: Dexmedetomidine

2mcg/kg

Drug: Placebo

Flavored placebo syrup

Active Comparator: Dexmedetomidine 3mcg/kg + placebo

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

Drug: Dexmedetomidine

3mcg/kg

Drug: Placebo

Flavored placebo syrup

Outcome Measures

Primary Outcome Measures

Time to sedation [30 minutes]
Achieve Ramsay sedation >3 within 30 minutes of administration of drug

Secondary Outcome Measures

Duration of sedation level >3 [Patients will be followed for the duration of the procedure, average of 1 hour]
The number of sonographer pauses [Participants will be followed for the duration of the procedure, average of 1 hour]
The number of sonographer pauses over 2 minutes due to patient movement or medical interventions will be counted
Need for rescue dexmedetomidine [Participants will be followed for the duration of the procedure, average of 1 hour]
The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE.
Incidence of respiratory complications [Participants will be followed for the duration of the hospital stay, average of 2 hours]
Documentation of the incidence of respiratory complications
Vital sign deviations of more than 30% from baseline [Participants will be followed for the duration of the hospital stay, average of 2 hours]
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.
Post anesthesia drowsiness [Participants will be followed for the duration of the post procedure stay, average of 1 hour]
Documentation of the incidence of post anesthesia drowsiness
Duration of Post Anesthesia Care Unit phase [Participants will be followed for the duration of the post procedure stay, average of 1 hour]
Documentation of the stay in Post Anesthesia Care Unit in minutes
Time to oral fluid intake [Participants will be followed for the duration of the post procedure stay, average of 1 hour]
Documentation of the time (in minutes) to oral fluid intake during the PACU phase
Time to discharge [Participants will be followed for the duration of the post procedure stay, average of 1 hour]
Documentation of the hospital stay after completion of the TTE.
Satisfaction of parents [Up to 3 days]
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.
Severity of respiratory complications [Participants will be followed for the duration of the hospital stay, average of 2 hours]
Documentation of the severity of respiratory complications
Post anesthesia agitation [Participants will be followed for the duration of the post procedure stay, average of 1 hour]
Documentation of the incidence of post anesthesia agitation

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 36 Months

Sexes Eligible for Study:

All

Accepts 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)