<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/NCT02228135</url>
  </required_header>
  <id_info>
    <org_study_id>IRB14-00588</org_study_id>
    <nct_id>NCT02228135</nct_id>
  </id_info>
  <brief_title>The Effect of Dexamethasone Dosing on Post-tonsillectomy Hemorrhage</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nicole Elsey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a retrospective chart review looking at the effect of dexamethasone dosing on&#xD;
      post-tonsillectomy hemorrhage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dexamethasone Dosage</measure>
    <time_frame>once at start of surgery</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">9843</enrollment>
  <condition>Tonsillectomy</condition>
  <condition>Adenotonsillectomy</condition>
  <arm_group>
    <arm_group_label>Non post-tonsillectomy hemorrhage</arm_group_label>
    <description>Children who do not have post-tonsillectomy hemorrhage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-tonsillectomy hemorrhage</arm_group_label>
    <description>Children return to the hospital after surgery with post-tonsillectomy hemorrhage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <arm_group_label>Non post-tonsillectomy hemorrhage</arm_group_label>
    <arm_group_label>Post-tonsillectomy hemorrhage</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children who have had tonsillectomy or adenotonsillectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing a tonsillectomy&#xD;
&#xD;
          -  Patients undergoing an adenotonsillectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients with a known history of bleeding or clotting disorders, as well as those&#xD;
             patients who had presented to Nationwide Children's Hospital main operating room for&#xD;
             control of PTH but had their initial tonsillectomy/adenotonsillectomy at an outlying&#xD;
             facility will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>July 24, 2017</last_update_submitted>
  <last_update_submitted_qc>July 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Nicole Elsey</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</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/NCT02228135
org study id: IRB14-00588
nct id: NCT02228135
lead sponsor: 
has dmc: No
This is a retrospective chart review looking at the effect of dexamethasone dosing on
      post-tonsillectomy hemorrhage.
observational model: Cohort
time perspective: Retrospective
measure: Dexamethasone Dosage
time frame: once at start of surgery
arm group label: Non post-tonsillectomy hemorrhage
description: Children who do not have post-tonsillectomy hemorrhage.
arm group label: Post-tonsillectomy hemorrhage
description: Children return to the hospital after surgery with post-tonsillectomy hemorrhage.
intervention type: Drug
intervention name: Dexamethasone
arm group label: Non post-tonsillectomy hemorrhage
arm group label: Post-tonsillectomy hemorrhage
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Nicole Elsey
investigator title: Clinical Assistant Professor
mesh term: Dexamethasone