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

NCT02250820 | Completed Phase 1 DMC

• 1 other identifier: 2014-5961
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Disease

Keywords

Pediatric; Sedation; Transthoracic echocardiography; TTE; Dexmedetomidine; Pentobarbital

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Time to sedation

  Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes

• Delirium prior to 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

  Participants will be followed for the duration of the procedure, an expected average of 1 hour

• Need for rescue nasal Dexmedetomidine

  Participants will be followed for the duration of the procedure, an expected average of 1 hour

Study Arms (2)

Nasal Dexmedetomidine and oral placebo

EXPERIMENTAL

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; Other: Oral Placebo

Nasal placebo and oral pentobarbital

EXPERIMENTAL

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; Other: Nasal Placebo

Interventions

Dexmedetomidine DRUG

Nasal administration

Nasal Dexmedetomidine and oral placebo

Pentobarbital DRUG

Oral administration

Nasal placebo and oral pentobarbital

Oral Placebo OTHER

Oral placebo will be cherry syrup

Also known as: Cherry Syrup

Nasal Dexmedetomidine and oral placebo

Nasal Placebo OTHER

Nasal placebo will be nasally atomized saline

Also known as: Nasally atomized saline

Nasal placebo and oral pentobarbital

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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.

  PMID: 29369091 DERIVED

MeSH Terms

Conditions

Heart Diseases

Interventions

Dexmedetomidine; Pentobarbital

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Barbiturates; Pyrimidinones; Pyrimidines

Study Officials

• Jeff Miller, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 26, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 21, 2020

Record last verified: 2020-01

Locations

US (1)