A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)

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 pentobarbital,

- The other provides sedation through the nose with the drug dexmedetomidine.

The choice of which method is used is based on evaluation of the patient's medical history
and the preference of the anesthesiologist. To our knowledge, no study has compared these
two sedation techniques for quality of care. The proposed study will help us determine which
method yields the best quality and will allow us to improve the healthcare experience of our
patients.

Inclusion Criteria:

- 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 Criteria:

- 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)