<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/NCT02985840</url>
  </required_header>
  <id_info>
    <org_study_id>1066755 (13-0056)</org_study_id>
    <nct_id>NCT02985840</nct_id>
  </id_info>
  <brief_title>Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department</brief_title>
  <official_title>Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OhioHealth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OhioHealth</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nausea is a common complaint in patients who present to the emergency department (ED).&#xD;
      Although the number of conditions that can present with nausea are numerous, the mainstay of&#xD;
      treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but&#xD;
      also its availability. One of the major drawbacks to using this form is that it often needs&#xD;
      to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV&#xD;
      ondansetron given with IV dexamethasone (Decadron) as another viable option when treating&#xD;
      patients with nausea in the emergency department.&#xD;
&#xD;
      Previous studies in patients undergoing surgical procedures have shown that when IV&#xD;
      dexamethasone is given with IV ondansetron to post-operative patients they have less nausea&#xD;
      and vomiting than ondansetron alone, and were even found to show decreased post-operative&#xD;
      pain associated with nausea. It has also been shown to decrease the need to re-dose&#xD;
      antiemetic medication. Although this combination has not been tested in the emergency&#xD;
      department it is believed by these investigators that the additional use of dexamethasone may&#xD;
      decrease the need to use repeated doses of ondansetron.&#xD;
&#xD;
      The investigators believe this may change the way physicians currently approach the nauseated&#xD;
      patient in regards to treatment. That rather than possibly giving multiple doses of one&#xD;
      medication over and over to reduce a patient's nausea, physicians can give two medications&#xD;
      together at one time. The investigators hope to demonstrate that by giving intravenous&#xD;
      dexamethasone and ondansetron together, it may be possible to reduce the number of patients&#xD;
      who need additional doses of nausea medication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nausea is a common complaint in patients who present to the emergency department (ED).&#xD;
      Although the number of conditions that can present with nausea are numerous, the mainstay of&#xD;
      treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but&#xD;
      also its availability. One of the major drawbacks to using this form is that it often needs&#xD;
      to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV&#xD;
      ondansetron given with IV dexamethasone (Decadron) as another viable option when treating&#xD;
      patients with nausea in the emergency department.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to access EMR for patients enrolled prior to 8/2015 for data collection&#xD;
  </why_stopped>
  <start_date type="Actual">January 28, 2014</start_date>
  <completion_date type="Actual">November 15, 2016</completion_date>
  <primary_completion_date type="Actual">November 15, 2016</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Need for Additional Nausea Medications</measure>
    <time_frame>1 hour post intervention</time_frame>
    <description>Effectiveness of intervention will be assessed by the need for additional medications via chart review</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Resolution of Nausea and Abdominal Pain Symptoms</measure>
    <time_frame>1 hour post intervention</time_frame>
    <description>Effectiveness of intervention will be assessed by the resolution of symptoms via chart review</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Nausea</condition>
  <condition>Abdominal Pain</condition>
  <arm_group>
    <arm_group_label>Ondansetron</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ondansetron (4 mg) followed by two 5 ml normal saline flush</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ondansetron plus dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ondansetron</intervention_name>
    <description>Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes</description>
    <arm_group_label>Ondansetron</arm_group_label>
    <arm_group_label>Ondansetron plus dexamethasone</arm_group_label>
    <other_name>Zofran</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush</description>
    <arm_group_label>Ondansetron plus dexamethasone</arm_group_label>
    <other_name>Decadron</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chief Complaint of nausea or abdominal pain with nausea&#xD;
&#xD;
          -  Inability to tolerate oral nausea medication&#xD;
&#xD;
          -  Patients with a negative pregnancy test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years of age&#xD;
&#xD;
          -  Patient's chief complaint includes headache, chest pain, or dizziness&#xD;
&#xD;
          -  Patients with whom there are contraindications to using the studied medicine&#xD;
             (allergies, known adrenal disease)&#xD;
&#xD;
          -  Blood sugar greater than 300&#xD;
&#xD;
          -  Non-English speaking subjects&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Little, D.O.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Attending Physician</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OhioHealth Doctors Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <results_first_submitted>July 25, 2018</results_first_submitted>
  <results_first_submitted_qc>August 28, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 26, 2018</results_first_posted>
  <last_update_submitted>August 28, 2018</last_update_submitted>
  <last_update_submitted_qc>August 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>OhioHealth</investigator_affiliation>
    <investigator_full_name>Andrew Little</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <keyword>ondansetron</keyword>
  <keyword>dexamethasone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Abdominal Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Ondansetron</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ondansetron</title>
          <description>Ondansetron (4 mg) followed by two 5 ml normal saline flush&#xD;
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes</description>
        </group>
        <group group_id="P2">
          <title>Ondansetron Plus Dexamethasone</title>
          <description>Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush&#xD;
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes&#xD;
Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ondansetron</title>
          <description>Ondansetron (4 mg) followed by two 5 ml normal saline flush&#xD;
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes</description>
        </group>
        <group group_id="B2">
          <title>Ondansetron Plus Dexamethasone</title>
          <description>Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush&#xD;
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes&#xD;
Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="64"/>
            <count group_id="B2" value="63"/>
            <count group_id="B3" value="127"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.77" spread="11.46"/>
                    <measurement group_id="B2" value="34.65" spread="12.75"/>
                    <measurement group_id="B3" value="35.21" spread="12.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Need for Additional Nausea Medications</title>
        <description>Effectiveness of intervention will be assessed by the need for additional medications via chart review</description>
        <time_frame>1 hour post intervention</time_frame>
        <population>Evaluation of this outcome (need for additional medications within 1 hr of intervention) required additional chart review, which was not performed. As such, this outcome was not collected or analyzed, and cannot be reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Ondansetron</title>
            <description>Ondansetron (4 mg) followed by two 5 ml normal saline flush&#xD;
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes</description>
          </group>
          <group group_id="O2">
            <title>Ondansetron Plus Dexamethasone</title>
            <description>Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush&#xD;
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes&#xD;
Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Need for Additional Nausea Medications</title>
          <description>Effectiveness of intervention will be assessed by the need for additional medications via chart review</description>
          <population>Evaluation of this outcome (need for additional medications within 1 hr of intervention) required additional chart review, which was not performed. As such, this outcome was not collected or analyzed, and cannot be reported.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Resolution of Nausea and Abdominal Pain Symptoms</title>
        <description>Effectiveness of intervention will be assessed by the resolution of symptoms via chart review</description>
        <time_frame>1 hour post intervention</time_frame>
        <population>Evaluation of this outcome (resolution of symptoms following intervention) required additional chart review, which was not collected. As such, this outcome was not collected or analyzed, and cannot be reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Ondansetron</title>
            <description>Ondansetron (4 mg) followed by two 5 ml normal saline flush&#xD;
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes</description>
          </group>
          <group group_id="O2">
            <title>Ondansetron Plus Dexamethasone</title>
            <description>Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush&#xD;
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes&#xD;
Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Resolution of Nausea and Abdominal Pain Symptoms</title>
          <description>Effectiveness of intervention will be assessed by the resolution of symptoms via chart review</description>
          <population>Evaluation of this outcome (resolution of symptoms following intervention) required additional chart review, which was not collected. As such, this outcome was not collected or analyzed, and cannot be reported.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants are in the study from time of enrollment until they are discharged from the emergency department. Adverse Events are collected during study enrollment. Incidence of adverse events were collected throughout the patient admission to the Emergency Department, per standard care procedures.</time_frame>
      <desc>Adverse event reporting followed local, state and federal regulations.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ondansetron</title>
          <description>Ondansetron (4 mg) followed by two 5 ml normal saline flush&#xD;
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes</description>
        </group>
        <group group_id="E2">
          <title>Ondansetron Plus Dexamethasone</title>
          <description>Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush&#xD;
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes&#xD;
Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to the transfer of electronic medical record systems, investigators were unable to access data from patients who were enrolled prior to August 2015 for the retrospective chart review component of this study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Chelsea Blessing, PhD</name_or_title>
      <organization>OhioHealth Research Institutute</organization>
      <phone>(513) 461-1772</phone>
      <email>chelsea.blessing@ohiohealth.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02985840
org study id: 1066755 (13-0056)
nct id: NCT02985840
lead sponsor: 
has dmc: No
Nausea is a common complaint in patients who present to the emergency department (ED).
      Although the number of conditions that can present with nausea are numerous, the mainstay of
      treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but
      also its availability. One of the major drawbacks to using this form is that it often needs
      to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV
      ondansetron given with IV dexamethasone (Decadron) as another viable option when treating
      patients with nausea in the emergency department.

      Previous studies in patients undergoing surgical procedures have shown that when IV
      dexamethasone is given with IV ondansetron to post-operative patients they have less nausea
      and vomiting than ondansetron alone, and were even found to show decreased post-operative
      pain associated with nausea. It has also been shown to decrease the need to re-dose
      antiemetic medication. Although this combination has not been tested in the emergency
      department it is believed by these investigators that the additional use of dexamethasone may
      decrease the need to use repeated doses of ondansetron.

      The investigators believe this may change the way physicians currently approach the nauseated
      patient in regards to treatment. That rather than possibly giving multiple doses of one
      medication over and over to reduce a patient's nausea, physicians can give two medications
      together at one time. The investigators hope to demonstrate that by giving intravenous
      dexamethasone and ondansetron together, it may be possible to reduce the number of patients
      who need additional doses of nausea medication.
Nausea is a common complaint in patients who present to the emergency department (ED).
      Although the number of conditions that can present with nausea are numerous, the mainstay of
      treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but
      also its availability. One of the major drawbacks to using this form is that it often needs
      to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV
      ondansetron given with IV dexamethasone (Decadron) as another viable option when treating
      patients with nausea in the emergency department.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number of Participants With Need for Additional Nausea Medications
time frame: 1 hour post intervention
description: Effectiveness of intervention will be assessed by the need for additional medications via chart review
measure: Number of Participants With Resolution of Nausea and Abdominal Pain Symptoms
time frame: 1 hour post intervention
description: Effectiveness of intervention will be assessed by the resolution of symptoms via chart review
arm group label: Ondansetron
arm group type: Active Comparator
description: Ondansetron (4 mg) followed by two 5 ml normal saline flush
arm group label: Ondansetron plus dexamethasone
arm group type: Experimental
description: Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush
intervention type: Drug
intervention name: Ondansetron
description: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes
arm group label: Ondansetron
arm group label: Ondansetron plus dexamethasone
other name: Zofran
intervention type: Drug
intervention name: Dexamethasone
description: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush
arm group label: Ondansetron plus dexamethasone
other name: Decadron
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Little, D.O.
role: Principal Investigator
affiliation: Attending Physician
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: OhioHealth
investigator full name: Andrew Little
investigator title: Attending Physician
mesh term: Emergencies
mesh term: Nausea
mesh term: Abdominal Pain
mesh term: Dexamethasone
mesh term: Ondansetron
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to the transfer of electronic medical record systems, investigators were unable to access data from patients who were enrolled prior to August 2015 for the retrospective chart review component of this study.
point of contact: 