<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02250820</url>
  </required_header>
  <id_info>
    <org_study_id>2014-5961</org_study_id>
    <nct_id>NCT02250820</nct_id>
  </id_info>
  <brief_title>A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)</brief_title>
  <official_title>A Qualitative Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will examine the quality of two sedation techniques (dexmedetomidine and&#xD;
      pentobarbital) used for children aged 3 to 24 months who are undergoing a transthoracic&#xD;
      echocardiography (TTE).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently there are two sedation methods used for children less than 24 months of age&#xD;
      undergoing transthoracic echocardiography (TTE).&#xD;
&#xD;
        -  One method provides sedation by mouth with the drug pentobarbital,&#xD;
&#xD;
        -  The other provides sedation through the nose with the drug dexmedetomidine.&#xD;
&#xD;
      The choice of which method is used is based on evaluation of the patient's medical history&#xD;
      and the preference of the anesthesiologist. To our knowledge, no study has compared these two&#xD;
      sedation techniques for quality of care. The proposed study will help us determine which&#xD;
      method yields the best quality and will allow us to improve the healthcare experience of our&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sedation Quality</measure>
    <time_frame>60 minutes</time_frame>
    <description>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 &gt;3.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to sedation</measure>
    <time_frame>Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes</time_frame>
    <description>Time from first dose of sedative medication to sedation. Sedation is defined as achieving Ramsay sedation level &gt;3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delirium prior to sedation</measure>
    <time_frame>Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes</time_frame>
    <description>The incidence of delirium prior to achieving sedation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of sedation level &gt;3</measure>
    <time_frame>Participants will be followed for the duration of the procedure, an expected average of 1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sonographer Pauses</measure>
    <time_frame>Participants will be followed for the duration of the procedure, an expected average of 1 hour</time_frame>
    <description>The number of sonographer pauses over 2 minutes due to patient movement or medical intervention will be counted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for rescue nasal Dexmedetomidine</measure>
    <time_frame>Participants will be followed for the duration of the procedure, an expected average of 1 hour</time_frame>
    <description>The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence-severity of respiratory complications</measure>
    <time_frame>Participants will be followed for the duration of their outpatient hospital stay, an expected average of 2 hours</time_frame>
    <description>We will document the incidence and severity of respiratory complications (including supplemental oxygen).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital sign deviations of more than 30% from baseline</measure>
    <time_frame>Participants will be followed for the duration of their outpatient hospital stay, an expected average of 2 hours</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post anesthesia drowsiness or agitation</measure>
    <time_frame>Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour</time_frame>
    <description>We will document the incidence-severity of post anesthesia drowsiness or agitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Post Anesthesia Care Unit (PACU) Phase</measure>
    <time_frame>Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour</time_frame>
    <description>We will document the duration of stay in Post Anesthesia Care Unit (PACU) phase in minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to oral fluid intake</measure>
    <time_frame>Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour</time_frame>
    <description>We will document the time (in minutes) to oral fluid intake during the PACU phase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to discharge</measure>
    <time_frame>Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour</time_frame>
    <description>We will document the time it takes a patient to be discharged from the hospital after the completion of the TTE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of the Parents</measure>
    <time_frame>up to 3 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Heart Disease</condition>
  <arm_group>
    <arm_group_label>Nasal Dexmedetomidine and oral placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasal placebo and oral pentobarbital</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Nasal administration</description>
    <arm_group_label>Nasal Dexmedetomidine and oral placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pentobarbital</intervention_name>
    <description>Oral administration</description>
    <arm_group_label>Nasal placebo and oral pentobarbital</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oral Placebo</intervention_name>
    <description>Oral placebo will be cherry syrup</description>
    <arm_group_label>Nasal Dexmedetomidine and oral placebo</arm_group_label>
    <other_name>Cherry Syrup</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nasal Placebo</intervention_name>
    <description>Nasal placebo will be nasally atomized saline</description>
    <arm_group_label>Nasal placebo and oral pentobarbital</arm_group_label>
    <other_name>Nasally atomized saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatients, scheduled to receive sedation for elective transthoracic echocardiography&#xD;
&#xD;
          -  The subject must be a candidate for both anesthetic techniques. A staff member of the&#xD;
             Division of Cardiac Anesthesiology will make this decision.&#xD;
&#xD;
          -  The subjects must be 3 months to 24 months (inclusive of the 24th month).&#xD;
&#xD;
          -  The subject's legally authorized representative has given written informed consent to&#xD;
             participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has a history of cardiac conduction system disease (e.g. 1st or 2nd degree&#xD;
             Atrioventricular block) or channelopathy (e.g. long QT syndrome).&#xD;
&#xD;
          -  The subject is taking digoxin, alpha-adrenergic or beta-adrenergic agonist or&#xD;
             antagonist (e.g., clonidine, propranolol, albuterol), anti-arrhythmic medications, or&#xD;
             vasodilators (e.g. ACE inhibitors) on the day of the study procedures. It is routine&#xD;
             for children taking these medications to hold them on the day of their procedure, as&#xD;
             requested by the clinical team.&#xD;
&#xD;
          -  The subject has received a dose of any other sedative within 48 hours.&#xD;
&#xD;
          -  The subject has life-threatening, medical conditions (American Society of&#xD;
             Anesthesiologists Physical Status 4, 5). The American Society of Anesthesiologists&#xD;
             (ASA) classification scale is a measure of physical status or how healthy the patient&#xD;
             is. For our study, we will focus on children which are defined as ASA I, II or III&#xD;
             which means a healthy child (ASA I), a child with a systemic disease that is mild and&#xD;
             well controlled (ASA II) or a child with systemic disease that is severe and&#xD;
             controlled (ASA III).&#xD;
&#xD;
          -  The subject is allergic to or has a contraindication to any of the drugs or masking&#xD;
             flavored syrup used in the study.&#xD;
&#xD;
          -  The subject has previously been treated under this protocol.&#xD;
&#xD;
          -  The subject has Trisomy 21 (exaggerated risk of bradycardia)&#xD;
&#xD;
          -  The subject has severe coarctation of the aorta (risk of exaggerated vasoconstriction)&#xD;
&#xD;
          -  The subject has Moyamoya disease (risk of recurrent stroke)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeff Miller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>January 17, 2020</last_update_submitted>
  <last_update_submitted_qc>January 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pediatric</keyword>
  <keyword>Sedation</keyword>
  <keyword>Transthoracic echocardiography</keyword>
  <keyword>TTE</keyword>
  <keyword>Dexmedetomidine</keyword>
  <keyword>Pentobarbital</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pentobarbital</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02250820
org study id: 2014-5961
nct id: NCT02250820
lead sponsor: 
has dmc: Yes
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Sedation Quality
time frame: 60 minutes
description: 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.
measure: 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
description: Time from first dose of sedative medication to sedation. Sedation is defined as achieving Ramsay sedation level >3.
measure: 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
description: The incidence of delirium prior to achieving sedation.
measure: Duration of sedation level >3
time frame: Participants will be followed for the duration of the procedure, an expected average of 1 hour
measure: Sonographer Pauses
time frame: Participants will be followed for the duration of the procedure, an expected average of 1 hour
description: The number of sonographer pauses over 2 minutes due to patient movement or medical intervention will be counted.
measure: Need for rescue nasal Dexmedetomidine
time frame: Participants will be followed for the duration of the procedure, an expected average of 1 hour
description: The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE.
measure: 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
description: We will document the incidence and severity of respiratory complications (including supplemental oxygen).
measure: 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
description: 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.
measure: 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
description: We will document the incidence-severity of post anesthesia drowsiness or agitation.
measure: 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
description: We will document the duration of stay in Post Anesthesia Care Unit (PACU) phase in minutes.
measure: 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
description: We will document the time (in minutes) to oral fluid intake during the PACU phase
measure: Time to discharge
time frame: Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour
description: We will document the time it takes a patient to be discharged from the hospital after the completion of the TTE.
measure: Satisfaction of the Parents
time frame: up to 3 days
description: 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.
arm group label: Nasal Dexmedetomidine and oral placebo
arm group type: Experimental
description: 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.
arm group label: Nasal placebo and oral pentobarbital
arm group type: Experimental
description: 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.
intervention type: Drug
intervention name: Dexmedetomidine
description: Nasal administration
arm group label: Nasal Dexmedetomidine and oral placebo
intervention type: Drug
intervention name: Pentobarbital
description: Oral administration
arm group label: Nasal placebo and oral pentobarbital
intervention type: Other
intervention name: Oral Placebo
description: Oral placebo will be cherry syrup
arm group label: Nasal Dexmedetomidine and oral placebo
other name: Cherry Syrup
intervention type: Other
intervention name: Nasal Placebo
description: Nasal placebo will be nasally atomized saline
arm group label: Nasal placebo and oral pentobarbital
other name: Nasally atomized saline
criteria: 
gender: All
minimum age: 3 Months
maximum age: 24 Months
healthy volunteers: No
last name: Jeff Miller, MD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Pentobarbital
mesh term: Dexmedetomidine