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

NCT ID: NCT02250820

Last Updated: 2020-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-12-31

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.

Conditions

Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Nasal administration

Oral Placebo

Intervention Type: OTHER

Oral placebo will be cherry syrup

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.

Group Type: EXPERIMENTAL

Pentobarbital

Intervention Type: DRUG

Oral administration

Nasal Placebo

Intervention Type: OTHER

Nasal placebo will be nasally atomized saline

Interventions

Dexmedetomidine

Nasal administration

Intervention Type: DRUG

Pentobarbital

Oral administration

Intervention Type: DRUG

Oral Placebo

Oral placebo will be cherry syrup

Intervention Type: OTHER

Nasal Placebo

Nasal placebo will be nasally atomized saline

Intervention Type: OTHER

Other Intervention Names

Cherry Syrup; Nasally atomized saline

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)

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29369091 (View on PubMed)

Other Identifiers

2014-5961

Identifier Type: -

Identifier Source: org_study_id