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

A Qualitative Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography

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).

Study Overview

• Status: Completed
• Conditions: Heart Disease
• Intervention / Treatment: Drug: Dexmedetomidine; Other: Oral Placebo; Drug: Pentobarbital; Other: Nasal Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasal Dexmedetomidine and oral placebo; If the patient is assigned to the dexmedetomidine arm, they will receive dexmedetomidine through the nose. In order to keep the assignment blinded, the patient will also receive an oral placebo.	Drug: Dexmedetomidine; Nasal administration; Other: Oral Placebo; Oral placebo will be cherry syrup; Other Names: Cherry Syrup
Experimental: Nasal placebo and oral pentobarbital; If the patient is assigned to the pentobarbital arm, they will receive pentobarbital through the mouth. In order to keep the assignment blinded, the patient will also receive an nasal placebo.	Drug: Pentobarbital; Oral administration; Other: Nasal Placebo; Nasal placebo will be nasally atomized saline; Other Names: Nasally atomized saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation Quality	The primary outcome variable will be the sedation quality for the first 60 minutes after sedation drug is administered. It will be assessed if child is sedated within 30 minutes of administration of sedative drug, and if sedation is maintained for at least 30 minutes to allow a detailed transthoracic echocardiographic study. Sedation is defined as achieving Ramsay sedation level >3.	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to sedation	Time from first dose of sedative medication to sedation. Sedation is defined as achieving Ramsay sedation level >3.	Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes
Delirium prior to sedation	The incidence of delirium prior to achieving sedation.	Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes
Duration of sedation level >3		Participants will be followed for the duration of the procedure, an expected average of 1 hour
Sonographer Pauses	The number of sonographer pauses over 2 minutes due to patient movement or medical intervention will be counted.	Participants will be followed for the duration of the procedure, an expected average of 1 hour
Need for rescue nasal Dexmedetomidine	The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE.	Participants will be followed for the duration of the procedure, an expected average of 1 hour
Incidence-severity of respiratory complications	We will document the incidence and severity of respiratory complications (including supplemental oxygen).	Participants will be followed for the duration of their outpatient hospital stay, an expected average of 2 hours
Vital sign deviations of more than 30% from baseline	We will document the incidence of blood pressure or heart rate deviations of more than 30% from baseline. Baseline will be measured prior to sedative administration.	Participants will be followed for the duration of their outpatient hospital stay, an expected average of 2 hours
Post anesthesia drowsiness or agitation	We will document the incidence-severity of post anesthesia drowsiness or agitation.	Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour
Duration of Post Anesthesia Care Unit (PACU) Phase	We will document the duration of stay in Post Anesthesia Care Unit (PACU) phase in minutes.	Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour
Time to oral fluid intake	We will document the time (in minutes) to oral fluid intake during the PACU phase	Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour
Time to discharge	We will document the time it takes a patient to be discharged from the hospital after the completion of the TTE.	Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour
Satisfaction of the Parents	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.	up to 3 days

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Jeff Miller, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: September 24, 2014
• First Posted (Estimate): September 26, 2014

Study Record Updates

• Last Update Posted (Actual): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Pediatric; Sedation; Dexmedetomidine; Transthoracic echocardiography; TTE; Pentobarbital
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Adjuvants, Anesthesia; GABA Modulators; GABA Agents; Dexmedetomidine; Pentobarbital
• Other Study ID Numbers: 2014-5961