Clinical trial NCT02523144: Dexmedetomidine in Children Having Transthoracic Echocardiography
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Disease
Keywords: Transthoracic echocardiography
echo
TTE
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 279
Sex: ALL
Minimum age (years): 3
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sedation Techniques for children undergoing transthoracic echocardiography (TTE).

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Time to sedation
timeFrame: 30 minutes
Secondary outcomes:
measure: Duration of sedation level >3
timeFrame: Patients will be followed for the duration of the procedure, average of 1 hour
measure: The number of sonographer pauses
timeFrame: Participants will be followed for the duration of the procedure, average of 1 hour
measure: Need for rescue dexmedetomidine
timeFrame: Participants will be followed for the duration of the procedure, average of 1 hour
measure: Incidence of respiratory complications
timeFrame: Participants will be followed for the duration of the hospital stay, average of 2 hours
measure: Vital sign deviations of more than 30% from baseline
timeFrame: Participants will be followed for the duration of the hospital stay, average of 2 hours
measure: Post anesthesia drowsiness
timeFrame: Participants will be followed for the duration of the post procedure stay, average of 1 hour
measure: Duration of Post Anesthesia Care Unit phase
timeFrame: Participants will be followed for the duration of the post procedure stay, average of 1 hour
measure: Time to oral fluid intake
timeFrame: Participants will be followed for the duration of the post procedure stay, average of 1 hour
measure: Time to discharge
timeFrame: Participants will be followed for the duration of the post procedure stay, average of 1 hour
measure: Satisfaction of parents
timeFrame: Up to 3 days
measure: Severity of respiratory complications
timeFrame: Participants will be followed for the duration of the hospital stay, average of 2 hours
measure: Post anesthesia agitation
timeFrame: Participants will be followed for the duration of the post procedure stay, average of 1 hour
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Hospital
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jeffrey Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: