Clinical trial NCT02250820: A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)
Official title: A Qualitative Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Disease
Keywords: Pediatric
Sedation
Transthoracic echocardiography
TTE
Dexmedetomidine
Pentobarbital
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 280
Sex: ALL
Minimum age (years): 3
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Sedation Quality
timeFrame: 60 minutes
Secondary outcomes:
measure: Time to sedation
timeFrame: Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes
measure: Delirium prior to sedation
timeFrame: Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes
measure: Duration of sedation level >3
timeFrame: Participants will be followed for the duration of the procedure, an expected average of 1 hour
measure: Sonographer Pauses
timeFrame: Participants will be followed for the duration of the procedure, an expected average of 1 hour
measure: Need for rescue nasal Dexmedetomidine
timeFrame: Participants will be followed for the duration of the procedure, an expected average of 1 hour
measure: Incidence-severity of respiratory complications
timeFrame: Participants will be followed for the duration of their outpatient hospital stay, an expected average of 2 hours
measure: Vital sign deviations of more than 30% from baseline
timeFrame: Participants will be followed for the duration of their outpatient hospital stay, an expected average of 2 hours
measure: Post anesthesia drowsiness or agitation
timeFrame: Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour
measure: Duration of Post Anesthesia Care Unit (PACU) Phase
timeFrame: Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour
measure: Time to oral fluid intake
timeFrame: Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour
measure: Time to discharge
timeFrame: Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour
measure: Satisfaction of the Parents
timeFrame: up to 3 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jeff Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller JW, Ding L, Gunter JB, Lam JE, Lin EP, Paquin JR, Li BL, Spaeth JP, Kreeger RN, Divanovic A, Mahmoud M, Loepke AW. Comparison of Intranasal Dexmedetomidine and Oral Pentobarbital Sedation for Transthoracic Echocardiography in Infants and Toddlers: A Prospective, Randomized, Double-Blind Trial. Anesth Analg. 2018 Jun;126(6):2009-2016. doi: 10.1213/ANE.0000000000002791.