<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/NCT03779282</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00014439</org_study_id>
    <nct_id>NCT03779282</nct_id>
  </id_info>
  <brief_title>KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery</brief_title>
  <official_title>KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ochsner Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ochsner Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Strabismus surgery for children is a very common procedure, with a high incidence of&#xD;
      emergence delerium in the recovery room. A combination of intravenous&#xD;
      ketamine/dexmedetomidine, or ketodex, has been previously shown to reduce emergence delerium&#xD;
      in children undergoing adenotonsillectomy. Here, we study its application in strabismus&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2018</start_date>
  <completion_date type="Actual">September 15, 2018</completion_date>
  <primary_completion_date type="Actual">September 15, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pediatric Anesthesia Emergence Delirium scale scores</measure>
    <time_frame>up to 6 hours in recovery room</time_frame>
    <description>A low total score would indicate less emergence delirium</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>wong-baker or numeric pain scores, depending on age</measure>
    <time_frame>up to 6 hours in recovery room</time_frame>
    <description>A low total score would indicate less pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>discharge time</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>time the patient is actually discharged from recovery room</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Emergence Delirium</condition>
  <condition>Strabismus</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>pediatric patients undergoing outpatient strabismus surgery, and not receiving ketodex</description>
  </arm_group>
  <arm_group>
    <arm_group_label>study</arm_group_label>
    <description>pediatric patients undergoing outpatient strabismus surgery, and receiving ketodex</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>see descriptions</description>
    <arm_group_label>study</arm_group_label>
    <other_name>ketamine</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy children, aged 0-18 years, undergoing outpatient strabismus surgery under general&#xD;
        anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I/II children undergoing outpatient strabismus surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  anything not meeting the above&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Khaled Dajani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ochsner Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ochsner Main Campus</name>
      <address>
        <city>Jefferson</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hadi SM, Saleh AJ, Tang YZ, Daoud A, Mei X, Ouyang W. The effect of KETODEX on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane based-anesthesia. Int J Pediatr Otorhinolaryngol. 2015 May;79(5):671-6. doi: 10.1016/j.ijporl.2015.02.012. Epub 2015 Feb 19.</citation>
    <PMID>25770644</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ochsner Health System</investigator_affiliation>
    <investigator_full_name>Khaled Dajani</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Strabismus</mesh_term>
    <mesh_term>Emergence Delirium</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03779282
org study id: Pro00014439
nct id: NCT03779282
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Strabismus surgery for children is a very common procedure, with a high incidence of
      emergence delerium in the recovery room. A combination of intravenous
      ketamine/dexmedetomidine, or ketodex, has been previously shown to reduce emergence delerium
      in children undergoing adenotonsillectomy. Here, we study its application in strabismus
      surgery.
observational model: Case-Control
time perspective: Prospective
measure: Pediatric Anesthesia Emergence Delirium scale scores
time frame: up to 6 hours in recovery room
description: A low total score would indicate less emergence delirium
measure: wong-baker or numeric pain scores, depending on age
time frame: up to 6 hours in recovery room
description: A low total score would indicate less pain
measure: discharge time
time frame: up to 24 hours
description: time the patient is actually discharged from recovery room
arm group label: control
description: pediatric patients undergoing outpatient strabismus surgery, and not receiving ketodex
arm group label: study
description: pediatric patients undergoing outpatient strabismus surgery, and receiving ketodex
intervention type: Drug
intervention name: Dexmedetomidine
description: see descriptions
arm group label: study
other name: ketamine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Khaled Dajani, MD
role: Principal Investigator
affiliation: Ochsner Health System
facility: 
country: United States
citation: Hadi SM, Saleh AJ, Tang YZ, Daoud A, Mei X, Ouyang W. The effect of KETODEX on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane based-anesthesia. Int J Pediatr Otorhinolaryngol. 2015 May;79(5):671-6. doi: 10.1016/j.ijporl.2015.02.012. Epub 2015 Feb 19.
PMID: 25770644
responsible party type: Principal Investigator
investigator affiliation: Ochsner Health System
investigator full name: Khaled Dajani
investigator title: Assistant Professor
mesh term: Delirium
mesh term: Strabismus
mesh term: Emergence Delirium
mesh term: Dexmedetomidine
mesh term: Ketamine
sharing ipd: No