<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/NCT03778372</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00014855</org_study_id>
    <nct_id>NCT03778372</nct_id>
  </id_info>
  <brief_title>Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery</brief_title>
  <official_title>Methadone 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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Strabismus surgery for children is a very common procedure, with a high incidence of&#xD;
      emergence delirium in the recovery room. Pain is often implicated in delirium. The primary&#xD;
      aim of this study is to determine whether a single, intraoperative dose of methadone for&#xD;
      outpatient ambulatory pediatric strabismus surgery reduces postoperative delirium.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 13, 2020</completion_date>
  <primary_completion_date type="Actual">December 13, 2020</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>measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.</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>measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.</time_frame>
    <description>A low total score would indicate less pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>discharge time</measure>
    <time_frame>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">55</enrollment>
  <condition>Emergence Delirium</condition>
  <condition>Strabismus</condition>
  <arm_group>
    <arm_group_label>study</arm_group_label>
    <description>pediatric patients undergoing outpatient strabismus surgery, and receiving methadone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>pediatric patients undergoing outpatient strabismus surgery, and not receiving methadone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methadone</intervention_name>
    <description>see desc above</description>
    <arm_group_label>study</arm_group_label>
  </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>0 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <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>Komen H, Brunt LM, Deych E, Blood J, Kharasch ED. Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study. Anesth Analg. 2019 Apr;128(4):802-810. doi: 10.1213/ANE.0000000000003464.</citation>
    <PMID>29847382</PMID>
  </reference>
  <reference>
    <citation>Ward RM, Drover DR, Hammer GB, Stemland CJ, Kern S, Tristani-Firouzi M, Lugo RA, Satterfield K, Anderson BJ. The pharmacokinetics of methadone and its metabolites in neonates, infants, and children. Paediatr Anaesth. 2014 Jun;24(6):591-601. doi: 10.1111/pan.12385. Epub 2014 Mar 26.</citation>
    <PMID>24666686</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 11, 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>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2022</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>Methadone</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/NCT03778372
org study id: Pro00014855
nct id: NCT03778372
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Strabismus surgery for children is a very common procedure, with a high incidence of
      emergence delirium in the recovery room. Pain is often implicated in delirium. The primary
      aim of this study is to determine whether a single, intraoperative dose of methadone for
      outpatient ambulatory pediatric strabismus surgery reduces postoperative delirium.
observational model: Case-Control
time perspective: Prospective
measure: Pediatric Anesthesia Emergence Delirium scale scores
time frame: measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.
description: A low total score would indicate less emergence delirium
measure: wong-baker or numeric pain scores, depending on age
time frame: measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.
description: A low total score would indicate less pain
measure: discharge time
time frame: 24 hours
description: time the patient is actually discharged from recovery room
arm group label: study
description: pediatric patients undergoing outpatient strabismus surgery, and receiving methadone
arm group label: control
description: pediatric patients undergoing outpatient strabismus surgery, and not receiving methadone
intervention type: Drug
intervention name: Methadone
description: see desc above
arm group label: study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Komen H, Brunt LM, Deych E, Blood J, Kharasch ED. Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study. Anesth Analg. 2019 Apr;128(4):802-810. doi: 10.1213/ANE.0000000000003464.
PMID: 29847382
citation: Ward RM, Drover DR, Hammer GB, Stemland CJ, Kern S, Tristani-Firouzi M, Lugo RA, Satterfield K, Anderson BJ. The pharmacokinetics of methadone and its metabolites in neonates, infants, and children. Paediatr Anaesth. 2014 Jun;24(6):591-601. doi: 10.1111/pan.12385. Epub 2014 Mar 26.
PMID: 24666686
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: Methadone
sharing ipd: No