Status:
COMPLETED
A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Heart Disease
Eligibility:
All Genders
3-24 years
Phase:
PHASE1
Brief Summary
The study will examine the quality of two sedation techniques (dexmedetomidine and pentobarbital) used for children aged 3 to 24 months who are undergoing a transthoracic echocardiography (TTE).
Detailed Description
Currently there are two sedation methods used for children less than 24 months of age undergoing transthoracic echocardiography (TTE). * One method provides sedation by mouth with the drug pentobarbi...
Eligibility Criteria
Inclusion
- Outpatients, scheduled to receive sedation for elective transthoracic echocardiography
- The subject must be a candidate for both anesthetic techniques. A staff member of the Division of Cardiac Anesthesiology will make this decision.
- The subjects must be 3 months to 24 months (inclusive of the 24th month).
- The subject's legally authorized representative has given written informed consent to participate in the study.
Exclusion
- The subject has a history of cardiac conduction system disease (e.g. 1st or 2nd degree Atrioventricular block) or channelopathy (e.g. long QT syndrome).
- 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) on the day of the study procedures. It is routine for children taking these medications to hold them on the day of their procedure, as requested by the clinical team.
- 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 or masking flavored syrup used in the study.
- The subject has previously been treated under this protocol.
- The subject has Trisomy 21 (exaggerated risk of bradycardia)
- The subject has severe coarctation of the aorta (risk of exaggerated vasoconstriction)
- The subject has Moyamoya disease (risk of recurrent stroke)
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT02250820
Start Date
November 1 2014
End Date
December 1 2017
Last Update
January 21 2020
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229