<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/NCT01725399</url>
  </required_header>
  <id_info>
    <org_study_id>12-1792</org_study_id>
    <nct_id>NCT01725399</nct_id>
  </id_info>
  <brief_title>Does First Oral Intake After Emergence Predict the Incidence of Post-operative Vomiting in Children?</brief_title>
  <acronym>XOndansetron</acronym>
  <official_title>Randomized Controlled Trial: Does First Oral Intake After Emergence From Anesthesia Predict the Incidence of Post-operative Vomiting in Children?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Second only to pain, nausea and vomiting are the most uncomfortable complications of surgery&#xD;
      and anesthesia. Unfortunately, our best defense against post-operative nausea and vomiting, a&#xD;
      medicine called ondansetron (Zofran), is in dire national shortage. Consequently,&#xD;
      non-pharmacological methods of prevention and treatment for post-operative nausea and&#xD;
      vomiting have increased import. Following emergence from general anesthesia, children often&#xD;
      request food and drink. There have been no studies to date that definitively determine the&#xD;
      optimal first food or drink choice for these children. This study proposes to randomize&#xD;
      children to either water or juice first intake following surgery. The investigators expect to&#xD;
      find that children who consume glucose are less likely to vomit than those who first receive&#xD;
      water.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative Vomiting</measure>
    <time_frame>24 hr post-op</time_frame>
    <description>Patients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">183</enrollment>
  <condition>Post-operative Vomiting</condition>
  <arm_group>
    <arm_group_label>Water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Water will be given as the study subject's first oral intake after emergence from general anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Apple Juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apple juice will be given as the study subject's first oral intake after emergence from general anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Apple Juice</intervention_name>
    <arm_group_label>Apple Juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water</intervention_name>
    <arm_group_label>Water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Dental surgery&#xD;
&#xD;
          -  Tonsillectomy and adenoidectomy&#xD;
&#xD;
          -  Strabismus surgery&#xD;
&#xD;
          -  Age 2-18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Parent refusal&#xD;
&#xD;
          -  Allergy / contraindication to ondansetron&#xD;
&#xD;
          -  Prone to vomiting&#xD;
&#xD;
          -  Inpatient&#xD;
&#xD;
          -  Preoperative anxiolysis with ketamine&#xD;
&#xD;
          -  Recovery location other than PACU&#xD;
&#xD;
          -  Nil per os at baseline&#xD;
&#xD;
          -  Presence of enteric tube&#xD;
&#xD;
          -  Contraindication to any part of the study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jamie R Wingate, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Chapel Hill</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peggy P McNaull, MD</last_name>
    <role>Study Chair</role>
    <affiliation>UNC Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>post-operative vomiting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_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/NCT01725399
org study id: 12-1792
nct id: NCT01725399
lead sponsor: 
has dmc: No
Second only to pain, nausea and vomiting are the most uncomfortable complications of surgery
      and anesthesia. Unfortunately, our best defense against post-operative nausea and vomiting, a
      medicine called ondansetron (Zofran), is in dire national shortage. Consequently,
      non-pharmacological methods of prevention and treatment for post-operative nausea and
      vomiting have increased import. Following emergence from general anesthesia, children often
      request food and drink. There have been no studies to date that definitively determine the
      optimal first food or drink choice for these children. This study proposes to randomize
      children to either water or juice first intake following surgery. The investigators expect to
      find that children who consume glucose are less likely to vomit than those who first receive
      water.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Double (Care Provider, Outcomes Assessor)
measure: Post-operative Vomiting
time frame: 24 hr post-op
description: Patients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively.
arm group label: Water
arm group type: Placebo Comparator
description: Water will be given as the study subject's first oral intake after emergence from general anesthesia.
arm group label: Apple Juice
arm group type: Experimental
description: Apple juice will be given as the study subject's first oral intake after emergence from general anesthesia.
intervention type: Other
intervention name: Apple Juice
arm group label: Apple Juice
intervention type: Other
intervention name: Water
arm group label: Water
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jamie R Wingate, MD
role: Principal Investigator
affiliation: UNC Chapel Hill
last name: Peggy P McNaull, MD
role: Study Chair
affiliation: UNC Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting