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

Overview

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).

Full Title of Study: “A Qualitative Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2017

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.

Interventions

  • Drug: Dexmedetomidine
    • Nasal administration
  • Drug: Pentobarbital
    • Oral administration
  • Other: Oral Placebo
    • Oral placebo will be cherry syrup
  • Other: Nasal Placebo
    • Nasal placebo will be nasally atomized saline

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Sedation Quality
    • Time Frame: 60 minutes
    • 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.

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 24 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Hospital Medical Center, Cincinnati
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jeff Miller, MD, Principal Investigator, Children’s Hospital Medical Center, Cincinnati

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