<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/NCT03300674</url>
  </required_header>
  <id_info>
    <org_study_id>2017-8408</org_study_id>
    <nct_id>NCT03300674</nct_id>
  </id_info>
  <brief_title>Intravenous Lidocaine Randomized Comparative Effectiveness Trial</brief_title>
  <official_title>Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain. A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a randomized, double-blind, emergency department based, comparative effectiveness&#xD;
      study of two medication for acute abdominal pain: intravenous lidocaine and intravenous&#xD;
      hydromorphone. Patients will be enrolled during an emergency department visit and followed&#xD;
      throughout their emergency department course and then by telephone 7 days later.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2018</start_date>
  <completion_date type="Actual">August 28, 2018</completion_date>
  <primary_completion_date type="Actual">August 16, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 0-10 Pain Scale Between Baseline and 90 Minutes</measure>
    <time_frame>up to 90 minutes</time_frame>
    <description>Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rescue Medication</measure>
    <time_frame>4 hours</time_frame>
    <description>no need for off-protocol parenteral pain medication during the ED visit. The following parenteral medications will be considered off protocol pain medication: any opioid, any non-steroidal anti-inflammatory drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>4 hours</time_frame>
    <description>Any new symptom development after administration of investigational medication</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Abdominal Pain</condition>
  <arm_group>
    <arm_group_label>Intravenous hydromorphone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydromorphone</intervention_name>
    <description>Hydromorphone intravenous infusion</description>
    <arm_group_label>Intravenous hydromorphone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Lidocaine intravenous infusion</description>
    <arm_group_label>Intravenous lidocaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:Eligible patients are those who present to an ED for treatment of acute&#xD;
        abdominal pain. Acute will be defined as pain for no more than seven days. At the time of&#xD;
        enrollment, the ED treatment plan must include use of an intravenous opioid.&#xD;
&#xD;
        Exclusion Criteria: Patients will be excluded from participation if they have cardiac&#xD;
        conduction system impairment (QTc duration &gt; 0.5s, QRS duration &gt; 0.12s, or PR interval&#xD;
        duration &gt; 0.2s), known renal (CKD &gt;2) or liver disease (Childs-Pugh B or greater), are&#xD;
        hemodynamically unstable, as determined by the attending physician, are pregnant or&#xD;
        breastfeeding, or have a known allergy to either medication. Patients will also be excluded&#xD;
        if they have used prescription or illicit opioids within the previous week, or if they have&#xD;
        a chronic pain disorder, defined as use of any analgesic medication on more days than not&#xD;
        during the month preceding the acute episode of pain. Patients weighing &lt; 60kg or &gt; 120kg&#xD;
        will be excluded.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <results_first_submitted>November 7, 2019</results_first_submitted>
  <results_first_submitted_qc>November 7, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 26, 2019</results_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montefiore Medical Center</investigator_affiliation>
    <investigator_full_name>Benjamin W. Friedman, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abdominal Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Hydromorphone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03300674/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intravenous Hydromorphone</title>
          <description>Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.&#xD;
Hydromorphone: Hydromorphone intravenous infusion</description>
        </group>
        <group group_id="P2">
          <title>Intravenous Lidocaine</title>
          <description>Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes&#xD;
Lidocaine: Lidocaine intravenous infusion</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="77"/>
              </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>Intravenous Hydromorphone</title>
          <description>Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.&#xD;
Hydromorphone: Hydromorphone intravenous infusion</description>
        </group>
        <group group_id="B2">
          <title>Intravenous Lidocaine</title>
          <description>Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes&#xD;
Lidocaine: Lidocaine intravenous infusion</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="77"/>
            <count group_id="B2" value="77"/>
            <count group_id="B3" value="154"/>
          </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="77"/>
                    <count group_id="B2" value="77"/>
                    <count group_id="B3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40" spread="13"/>
                    <measurement group_id="B2" value="42" spread="12"/>
                    <measurement group_id="B3" value="41" spread="13"/>
                  </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="77"/>
                    <count group_id="B2" value="77"/>
                    <count group_id="B3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="98"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="56"/>
                  </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>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="77"/>
                    <count group_id="B2" value="77"/>
                    <count group_id="B3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pain duration in days</title>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="77"/>
                    <count group_id="B2" value="77"/>
                    <count group_id="B3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="B2" value="2" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="B3" value="2" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in 0-10 Pain Scale Between Baseline and 90 Minutes</title>
        <description>Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable</description>
        <time_frame>up to 90 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intravenous Hydromorphone</title>
            <description>Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.&#xD;
Hydromorphone: Hydromorphone intravenous infusion</description>
          </group>
          <group group_id="O2">
            <title>Intravenous Lidocaine</title>
            <description>Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes&#xD;
Lidocaine: Lidocaine intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 0-10 Pain Scale Between Baseline and 90 Minutes</title>
          <description>Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="2.8"/>
                    <measurement group_id="O2" value="3.8" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rescue Medication</title>
        <description>no need for off-protocol parenteral pain medication during the ED visit. The following parenteral medications will be considered off protocol pain medication: any opioid, any non-steroidal anti-inflammatory drug</description>
        <time_frame>4 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intravenous Hydromorphone</title>
            <description>Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.&#xD;
Hydromorphone: Hydromorphone intravenous infusion</description>
          </group>
          <group group_id="O2">
            <title>Intravenous Lidocaine</title>
            <description>Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes&#xD;
Lidocaine: Lidocaine intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Rescue Medication</title>
          <description>no need for off-protocol parenteral pain medication during the ED visit. The following parenteral medications will be considered off protocol pain medication: any opioid, any non-steroidal anti-inflammatory drug</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events</title>
        <description>Any new symptom development after administration of investigational medication</description>
        <time_frame>4 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intravenous Hydromorphone</title>
            <description>Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.&#xD;
Hydromorphone: Hydromorphone intravenous infusion</description>
          </group>
          <group group_id="O2">
            <title>Intravenous Lidocaine</title>
            <description>Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes&#xD;
Lidocaine: Lidocaine intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Any new symptom development after administration of investigational medication</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intravenous Hydromorphone</title>
          <description>Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.&#xD;
Hydromorphone: Hydromorphone intravenous infusion</description>
        </group>
        <group group_id="E2">
          <title>Intravenous Lidocaine</title>
          <description>Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes&#xD;
Lidocaine: Lidocaine intravenous infusion</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="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="77"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>dizziness</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="77"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>drowsiness</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="77"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="77"/>
              </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>
    <point_of_contact>
      <name_or_title>Benjamin W. Friedman</name_or_title>
      <organization>Montefiore</organization>
      <phone>718-920-6626</phone>
      <email>befriedm@montefiore.org</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/NCT03300674
org study id: 2017-8408
nct id: NCT03300674
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a randomized, double-blind, emergency department based, comparative effectiveness
      study of two medication for acute abdominal pain: intravenous lidocaine and intravenous
      hydromorphone. Patients will be enrolled during an emergency department visit and followed
      throughout their emergency department course and then by telephone 7 days later.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blind
measure: Change in 0-10 Pain Scale Between Baseline and 90 Minutes
time frame: up to 90 minutes
description: Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable
measure: Rescue Medication
time frame: 4 hours
description: no need for off-protocol parenteral pain medication during the ED visit. The following parenteral medications will be considered off protocol pain medication: any opioid, any non-steroidal anti-inflammatory drug
measure: Adverse Events
time frame: 4 hours
description: Any new symptom development after administration of investigational medication
arm group label: Intravenous hydromorphone
arm group type: Active Comparator
description: Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.
arm group label: Intravenous lidocaine
arm group type: Active Comparator
description: Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes
intervention type: Drug
intervention name: Hydromorphone
description: Hydromorphone intravenous infusion
arm group label: Intravenous hydromorphone
intervention type: Drug
intervention name: Lidocaine
description: Lidocaine intravenous infusion
arm group label: Intravenous lidocaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Montefiore Medical Center
investigator full name: Benjamin W. Friedman, MD
investigator title: Professor
mesh term: Abdominal Pain
mesh term: Lidocaine
mesh term: Hydromorphone
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 