<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/NCT02227316</url>
  </required_header>
  <id_info>
    <org_study_id>14000359</org_study_id>
    <nct_id>NCT02227316</nct_id>
  </id_info>
  <brief_title>Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure</brief_title>
  <official_title>A Prospective, Double Blind, Randomized, Placebo Controlled Study to Compare the Effectiveness of Intravenous Acetaminophen and Intravenous Ibuprofen in Reducing Post Procedural Pain in the Uterine Fibroid Embolization Procedure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sponsor Name Pending</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The uterine fibroid embolization (UFE) procedure is a treatment option for abnormal heavy&#xD;
      menstrual bleeding and/or bulk symptoms associated with uterine fibroids and adenomyosis.&#xD;
      Post UFE procedural pain and nausea are expected events. These symptoms are treated with&#xD;
      current standard of care medications, including opiates.&#xD;
&#xD;
      Intra procedure pain medications include midazolam, fentanyl and hydromorphone. Some centers&#xD;
      include nonsteroidal anti-inflammatory medications (NSAIDS), including oral ibuprofen and IV&#xD;
      ketorolac. Post procedural pain control is centered on a hydromorphone patient-controlled&#xD;
      analgesia (PCA) infusion pump, as well as a NSAID regimen. Intra procedure and post procedure&#xD;
      nausea control medications include a transcutaneous scopolamine patch and IV anti-nausea&#xD;
      medications such as ondansetron and prochlorperazine.&#xD;
&#xD;
      This study is being conducted to compare two new medications for pain, IV ibuprofen and IV&#xD;
      acetaminophen, administered for 24 hours following UFE. The primary safety objective of&#xD;
      non-inferiority will be met and the primary efficacy objective of superiority, decreased pain&#xD;
      and nausea, will be accessed when compared to current standard of care regimens.&#xD;
&#xD;
      This is a 4 arm, double blind, randomized, controlled study. All patients will receive&#xD;
      standard of care baseline pain medications, including IV midazolam, fentanyl and&#xD;
      hydromorphone intra procedure, followed by a hydromorphone PCA infusion pump post procedure.&#xD;
      The 4 arms will include: [ Arm 1] IV ibuprofen/IV placebo, [Arm 2] IV acetaminophen/IV&#xD;
      placebo, [Arm 3] IV ibuprofen/IV acetaminophen, and [arm 4] IV placebo/IV placebo. These&#xD;
      medications will be given during the procedure and extended over a 24 hour stay.&#xD;
&#xD;
      Arm 4 (IV placebo/IV placebo) would replicate current standard of care, and therefore will&#xD;
      include IV push (IVP) ketorolac, which would be given at the end of the procedure and be&#xD;
      continued every 6 hours for the 24 hour stay. An IVP of saline will be given as a control&#xD;
      every 6 hours for the 24 hour stay to arms 1, 2 and 3. Pain and nausea will be measured at&#xD;
      intervals prior to the procedure, throughout the stay and at 2 weeks post procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, double blind, randomized controlled trial evaluating the effects of two new IV&#xD;
      medications, IV ibuprofen and IV acetaminophen, on standard of care pain and anti-emetic&#xD;
      management in Uterine Fibroid Embolization patients.&#xD;
&#xD;
        1. Four arm, double blind, randomized controlled study: all patients will receive standard&#xD;
           of care baseline pain medications, including IV midazolam, fentanyl and hydromorphone&#xD;
           during the procedure, followed by a hydromorphone PCA infusion pump during their&#xD;
           recovery. The four arms will include an IV ibuprofen/IV placebo, an IV acetaminophen/IV&#xD;
           placebo, an IV ibuprofen/IV acetaminophen, and a control arm (IV placebo/IV placebo).&#xD;
           The same amount of normal saline will be substituted for the experimental treatments if&#xD;
           the patient receives the placebo. These medications will be given during the procedure&#xD;
           and extended over a 24 hour recovery period. The medications given will be blinded to&#xD;
           the patient, the administrator, and the surveyor.&#xD;
&#xD;
        2. The placebo/placebo arm would replicate current standard of care, and therefore include&#xD;
           IV push (IVP) ketorolac, which would be given at the end of the procedure and be&#xD;
           continued for 24 hours at q6hour dosing. An IVP of saline would be given as a control&#xD;
           for 24 hours at q6hour dosing to the other three arms.&#xD;
&#xD;
        3. Dosage of medications will be standardized based on formulary indications: IV Ketorolac&#xD;
           30 mg/dose IVP, acetaminophen 1 gram/dose IV piggy back over 15 minutes every 6 hours,&#xD;
           ibuprofen 800 mg/dose IV piggy back over 30 minutes every 6 hours.&#xD;
&#xD;
        4. Variables measured: mean and maximum pain (VAS score at 0 hours, 6 hours, discharge and&#xD;
           2 weeks post procedure), opioid requirements, mean and maximum nausea (VAS score at 0&#xD;
           hours, 6 hours, discharge and 2 weeks post procedure), anti-emetic medication&#xD;
           requirements.&#xD;
&#xD;
           Weighted sum of pain intensity differences, with pain intensity measured on VAS over 24&#xD;
           hours (SPID24) will be used as a primary outcome. Satisfaction scores will be measured&#xD;
           at 24 hours using the validated APS-POQ-R questionnaire (6).&#xD;
&#xD;
        5. Other variables recorded: Age, height, weight, history of postoperative nausea and&#xD;
           vomiting or motion sickness, diagnosis, uterine volume, dominant fibroid size, arteries&#xD;
           embolized, presence of prominent ovarian arteries, volume of particle used, fluoroscopy&#xD;
           time for the procedure.&#xD;
&#xD;
        6. Technical parameters, which would remain constant, include: pre procedure and 6 month&#xD;
           follow up MRI contrast with gadolinium which is standard of care, embolization using&#xD;
           500-700 micron Embospheres (with limited use of 700-900 micron Embospheres), IV&#xD;
           hydration with 0.9% normal saline, antibiotics (IV ciprofloxacin 400 mg every 12 hours,&#xD;
           IV metronidazole 500 mg every six hours), urinary catheter placement, lower extremity&#xD;
           compression devices, and early ambulation.&#xD;
&#xD;
        7. In the interim analysis, the investigators will have 40 subjects in total with unequal&#xD;
           randomization ratio of 1:1:4:4. Additional subjects will be enrolled for a total of 35&#xD;
           subjects per arm for the final analysis (sum total N=140)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen</measure>
    <time_frame>24 hours</time_frame>
    <description>Primary efficacy objective is to compare the change in maximum level of pain experienced by patient over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of Mean Pain Intensity Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen</measure>
    <time_frame>24 hours</time_frame>
    <description>Primary efficacy objective is to compare the change in mean pain intensity score over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Nausea Intensity</measure>
    <time_frame>24 hours</time_frame>
    <description>Assessment of mean nausea by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Consumption</measure>
    <time_frame>24 hours</time_frame>
    <description>Mean opioid consumption in morphine equivalents over 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-Emetic Consumption</measure>
    <time_frame>24 hours</time_frame>
    <description>Mean dose of anti-emetic medication in milligrams given over 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Nausea Intensity</measure>
    <time_frame>24 hours</time_frame>
    <description>Assessment of maximum level of nausea experienced by patient, by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Symptomatic Uterine Fibroids and Adenomyosis</condition>
  <arm_group>
    <arm_group_label>Intravenous Ibuprofen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4 during uterine fibroid embolization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous acetaminophen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 during uterine fibroid embolization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IV ibuprofen/IV acetaminophen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 during uterine fibroid embolization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous placebo/Intravenous placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 during uterine fibroid embolization</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV Ibuprofen</intervention_name>
    <description>Uterine fibroid embolization</description>
    <arm_group_label>IV ibuprofen/IV acetaminophen</arm_group_label>
    <arm_group_label>Intravenous Ibuprofen</arm_group_label>
    <other_name>Uterine artery embolization</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV Acetaminophen</intervention_name>
    <description>Uterine fibroid embolization</description>
    <arm_group_label>IV ibuprofen/IV acetaminophen</arm_group_label>
    <arm_group_label>Intravenous acetaminophen</arm_group_label>
    <other_name>Uterine artery embolization</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous placebo/Intravenous placebo</intervention_name>
    <description>Uterine fibroid embolization</description>
    <arm_group_label>Intravenous placebo/Intravenous placebo</arm_group_label>
    <other_name>Uterine artery embolization</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients being considered for UFE including bleeding and/or bulk symptoms.&#xD;
&#xD;
          2. Women of all ethnicities&#xD;
&#xD;
          3. Ages 21-60&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with current malignancy receiving treatment&#xD;
&#xD;
          2. Women who are pregnant&#xD;
&#xD;
          3. Cognitive impairment&#xD;
&#xD;
          4. Clinically significant kidney disease&#xD;
&#xD;
          5. Clinically significant liver disease&#xD;
&#xD;
          6. Any recent history of gastrointestinal bleed or ulcer&#xD;
&#xD;
          7. Weight less than 50 kg (medication dosing requirements change below 50 kg)&#xD;
&#xD;
          8. Women with a body mass index (BMI) equal to or over 50 (with other co-morbidities)&#xD;
&#xD;
          9. Known allergy or hypersensitivity to NSAID or acetaminophen&#xD;
&#xD;
         10. Administration of acetaminophen, NSAID, narcotic or any other analgesic less than 6&#xD;
             hours prior to UFE procedure&#xD;
&#xD;
         11. Any chronic use of pain medications including acetaminophen, NSAID, narcotic or&#xD;
             analgesic&#xD;
&#xD;
         12. Patients who cannot or choose not to consent to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cheryl H Hoffman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jonathan S Jahr, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ronald Reagan UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Monica/UCLA Medical Center and Orthopaedic Hospital</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 26, 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>
  <results_first_submitted>December 13, 2017</results_first_submitted>
  <results_first_submitted_qc>June 5, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">June 8, 2018</results_first_posted>
  <last_update_submitted>June 5, 2018</last_update_submitted>
  <last_update_submitted_qc>June 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Cheryl Hoffman</investigator_full_name>
    <investigator_title>MD.</investigator_title>
  </responsible_party>
  <keyword>Uterine Fibroid Embolization</keyword>
  <keyword>Pain</keyword>
  <keyword>UFE</keyword>
  <keyword>Fibroids</keyword>
  <keyword>Adenomyosis</keyword>
  <keyword>Bleeding</keyword>
  <keyword>IV Acetaminophen</keyword>
  <keyword>IV Ibuprofen</keyword>
  <keyword>Menorrhagia</keyword>
  <keyword>Leiomyoma</keyword>
  <keyword>Patient Satisfaction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
    <mesh_term>Adenomyosis</mesh_term>
    <mesh_term>Pain, Procedural</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Ibuprofen</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>No participants were excluded before assignment to groups.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intravenous Ibuprofen</title>
          <description>Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.&#xD;
IV Ibuprofen</description>
        </group>
        <group group_id="P2">
          <title>Intravenous Acetaminophen</title>
          <description>Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4&#xD;
IV Acetaminophen</description>
        </group>
        <group group_id="P3">
          <title>IV Ibuprofen/IV Acetaminophen</title>
          <description>Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4&#xD;
IV Ibuprofen&#xD;
IV Acetaminophen</description>
        </group>
        <group group_id="P4">
          <title>Intravenous Placebo/Intravenous Placebo</title>
          <description>Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4&#xD;
IV Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intravenous Ibuprofen</title>
          <description>Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.&#xD;
IV Ibuprofen</description>
        </group>
        <group group_id="B2">
          <title>Intravenous Acetaminophen</title>
          <description>Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4&#xD;
IV Acetaminophen</description>
        </group>
        <group group_id="B3">
          <title>IV Ibuprofen/IV Acetaminophen</title>
          <description>Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4&#xD;
IV Ibuprofen&#xD;
IV Acetaminophen</description>
        </group>
        <group group_id="B4">
          <title>Intravenous Placebo/Intravenous Placebo</title>
          <description>Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4&#xD;
IV Placebo</description>
        </group>
        <group group_id="B5">
          <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="4"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="16"/>
            <count group_id="B4" value="16"/>
            <count group_id="B5" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.96" spread="3.22"/>
                    <measurement group_id="B2" value="45.24" spread="6.31"/>
                    <measurement group_id="B3" value="44.33" spread="4.32"/>
                    <measurement group_id="B4" value="44.49" spread="4.12"/>
                    <measurement group_id="B5" value="44.25" spread="4.27"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" 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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen</title>
        <description>Primary efficacy objective is to compare the change in maximum level of pain experienced by patient over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intravenous Ibuprofen</title>
            <description>Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.&#xD;
IV Ibuprofen</description>
          </group>
          <group group_id="O2">
            <title>Intravenous Acetaminophen</title>
            <description>Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4&#xD;
IV Acetaminophen</description>
          </group>
          <group group_id="O3">
            <title>IV Ibuprofen/IV Acetaminophen</title>
            <description>Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4&#xD;
IV Ibuprofen&#xD;
IV Acetaminophen</description>
          </group>
          <group group_id="O4">
            <title>Intravenous Placebo/Intravenous Placebo</title>
            <description>Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4&#xD;
IV Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen</title>
          <description>Primary efficacy objective is to compare the change in maximum level of pain experienced by patient over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.</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="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.48" spread="0.21"/>
                    <measurement group_id="O2" value="7.27" spread="1.17"/>
                    <measurement group_id="O3" value="6.16" spread="0.59"/>
                    <measurement group_id="O4" value="5.30" spread="1.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Evaluation of Mean Pain Intensity Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen</title>
        <description>Primary efficacy objective is to compare the change in mean pain intensity score over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intravenous Ibuprofen</title>
            <description>Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.&#xD;
IV Ibuprofen</description>
          </group>
          <group group_id="O2">
            <title>Intravenous Acetaminophen</title>
            <description>Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4&#xD;
IV Acetaminophen</description>
          </group>
          <group group_id="O3">
            <title>IV Ibuprofen/IV Acetaminophen</title>
            <description>Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4&#xD;
IV Ibuprofen&#xD;
IV Acetaminophen</description>
          </group>
          <group group_id="O4">
            <title>Intravenous Placebo/Intravenous Placebo</title>
            <description>Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4&#xD;
IV Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Mean Pain Intensity Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen</title>
          <description>Primary efficacy objective is to compare the change in mean pain intensity score over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.</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="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.52" spread="1.19"/>
                    <measurement group_id="O2" value="4.22" spread="0.92"/>
                    <measurement group_id="O3" value="3.90" spread="1.39"/>
                    <measurement group_id="O4" value="3.34" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Nausea Intensity</title>
        <description>Assessment of mean nausea by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intravenous Ibuprofen</title>
            <description>Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.&#xD;
IV Ibuprofen</description>
          </group>
          <group group_id="O2">
            <title>Intravenous Acetaminophen</title>
            <description>Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4&#xD;
IV Acetaminophen</description>
          </group>
          <group group_id="O3">
            <title>IV Ibuprofen/IV Acetaminophen</title>
            <description>Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4&#xD;
IV Ibuprofen&#xD;
IV Acetaminophen</description>
          </group>
          <group group_id="O4">
            <title>Intravenous Placebo/Intravenous Placebo</title>
            <description>Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4&#xD;
IV Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Nausea Intensity</title>
          <description>Assessment of mean nausea by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.</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="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.52" spread="0.91"/>
                    <measurement group_id="O2" value="3.20" spread="0.80"/>
                    <measurement group_id="O3" value="3.59" spread="0.35"/>
                    <measurement group_id="O4" value="2.38" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Opioid Consumption</title>
        <description>Mean opioid consumption in morphine equivalents over 24 hours</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intravenous Ibuprofen</title>
            <description>Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.&#xD;
IV Ibuprofen</description>
          </group>
          <group group_id="O2">
            <title>Intravenous Acetaminophen</title>
            <description>Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4&#xD;
IV Acetaminophen</description>
          </group>
          <group group_id="O3">
            <title>IV Ibuprofen/IV Acetaminophen</title>
            <description>Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4&#xD;
IV Ibuprofen&#xD;
IV Acetaminophen</description>
          </group>
          <group group_id="O4">
            <title>Intravenous Placebo/Intravenous Placebo</title>
            <description>Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4&#xD;
IV Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Consumption</title>
          <description>Mean opioid consumption in morphine equivalents over 24 hours</description>
          <units>Morphine equivalent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.75" spread="38.53"/>
                    <measurement group_id="O2" value="69.63" spread="7.30"/>
                    <measurement group_id="O3" value="48.44" spread="22.42"/>
                    <measurement group_id="O4" value="62.28" spread="35.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-Emetic Consumption</title>
        <description>Mean dose of anti-emetic medication in milligrams given over 24 hours</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intravenous Ibuprofen</title>
            <description>Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.&#xD;
IV Ibuprofen</description>
          </group>
          <group group_id="O2">
            <title>Intravenous Acetaminophen</title>
            <description>Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4&#xD;
IV Acetaminophen</description>
          </group>
          <group group_id="O3">
            <title>IV Ibuprofen/IV Acetaminophen</title>
            <description>Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4&#xD;
IV Ibuprofen&#xD;
IV Acetaminophen</description>
          </group>
          <group group_id="O4">
            <title>Intravenous Placebo/Intravenous Placebo</title>
            <description>Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4&#xD;
IV Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-Emetic Consumption</title>
          <description>Mean dose of anti-emetic medication in milligrams given over 24 hours</description>
          <units>Milligrams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.00" spread="8.64"/>
                    <measurement group_id="O2" value="19.50" spread="7.30"/>
                    <measurement group_id="O3" value="22.25" spread="7.72"/>
                    <measurement group_id="O4" value="19.50" spread="11.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Nausea Intensity</title>
        <description>Assessment of maximum level of nausea experienced by patient, by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intravenous Ibuprofen</title>
            <description>Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.&#xD;
IV Ibuprofen</description>
          </group>
          <group group_id="O2">
            <title>Intravenous Acetaminophen</title>
            <description>Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4&#xD;
IV Acetaminophen</description>
          </group>
          <group group_id="O3">
            <title>IV Ibuprofen/IV Acetaminophen</title>
            <description>Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4&#xD;
IV Ibuprofen&#xD;
IV Acetaminophen</description>
          </group>
          <group group_id="O4">
            <title>Intravenous Placebo/Intravenous Placebo</title>
            <description>Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4&#xD;
IV Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Nausea Intensity</title>
          <description>Assessment of maximum level of nausea experienced by patient, by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.</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="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.62" spread="2.88"/>
                    <measurement group_id="O2" value="5.25" spread="1.07"/>
                    <measurement group_id="O3" value="6.41" spread="0.94"/>
                    <measurement group_id="O4" value="3.71" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Intravenous Ibuprofen</title>
          <description>Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.&#xD;
IV Ibuprofen</description>
        </group>
        <group group_id="E2">
          <title>Intravenous Acetaminophen</title>
          <description>Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4&#xD;
IV Acetaminophen</description>
        </group>
        <group group_id="E3">
          <title>IV Ibuprofen/IV Acetaminophen</title>
          <description>Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4&#xD;
IV Ibuprofen&#xD;
IV Acetaminophen</description>
        </group>
        <group group_id="E4">
          <title>Intravenous Placebo/Intravenous Placebo</title>
          <description>Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4&#xD;
IV Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </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>Director of Clinical Research</name_or_title>
      <organization>UCLA Department of Radiological Sciences</organization>
      <phone>310-794-8995</phone>
      <email>schaabane@mednet.ucla.edu</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/NCT02227316
org study id: 14000359
nct id: NCT02227316
lead sponsor: 
collaborator: 
has dmc: No
The uterine fibroid embolization (UFE) procedure is a treatment option for abnormal heavy
      menstrual bleeding and/or bulk symptoms associated with uterine fibroids and adenomyosis.
      Post UFE procedural pain and nausea are expected events. These symptoms are treated with
      current standard of care medications, including opiates.

      Intra procedure pain medications include midazolam, fentanyl and hydromorphone. Some centers
      include nonsteroidal anti-inflammatory medications (NSAIDS), including oral ibuprofen and IV
      ketorolac. Post procedural pain control is centered on a hydromorphone patient-controlled
      analgesia (PCA) infusion pump, as well as a NSAID regimen. Intra procedure and post procedure
      nausea control medications include a transcutaneous scopolamine patch and IV anti-nausea
      medications such as ondansetron and prochlorperazine.

      This study is being conducted to compare two new medications for pain, IV ibuprofen and IV
      acetaminophen, administered for 24 hours following UFE. The primary safety objective of
      non-inferiority will be met and the primary efficacy objective of superiority, decreased pain
      and nausea, will be accessed when compared to current standard of care regimens.

      This is a 4 arm, double blind, randomized, controlled study. All patients will receive
      standard of care baseline pain medications, including IV midazolam, fentanyl and
      hydromorphone intra procedure, followed by a hydromorphone PCA infusion pump post procedure.
      The 4 arms will include: [ Arm 1] IV ibuprofen/IV placebo, [Arm 2] IV acetaminophen/IV
      placebo, [Arm 3] IV ibuprofen/IV acetaminophen, and [arm 4] IV placebo/IV placebo. These
      medications will be given during the procedure and extended over a 24 hour stay.

      Arm 4 (IV placebo/IV placebo) would replicate current standard of care, and therefore will
      include IV push (IVP) ketorolac, which would be given at the end of the procedure and be
      continued every 6 hours for the 24 hour stay. An IVP of saline will be given as a control
      every 6 hours for the 24 hour stay to arms 1, 2 and 3. Pain and nausea will be measured at
      intervals prior to the procedure, throughout the stay and at 2 weeks post procedure.
A prospective, double blind, randomized controlled trial evaluating the effects of two new IV
      medications, IV ibuprofen and IV acetaminophen, on standard of care pain and anti-emetic
      management in Uterine Fibroid Embolization patients.

        1. Four arm, double blind, randomized controlled study: all patients will receive standard
           of care baseline pain medications, including IV midazolam, fentanyl and hydromorphone
           during the procedure, followed by a hydromorphone PCA infusion pump during their
           recovery. The four arms will include an IV ibuprofen/IV placebo, an IV acetaminophen/IV
           placebo, an IV ibuprofen/IV acetaminophen, and a control arm (IV placebo/IV placebo).
           The same amount of normal saline will be substituted for the experimental treatments if
           the patient receives the placebo. These medications will be given during the procedure
           and extended over a 24 hour recovery period. The medications given will be blinded to
           the patient, the administrator, and the surveyor.

        2. The placebo/placebo arm would replicate current standard of care, and therefore include
           IV push (IVP) ketorolac, which would be given at the end of the procedure and be
           continued for 24 hours at q6hour dosing. An IVP of saline would be given as a control
           for 24 hours at q6hour dosing to the other three arms.

        3. Dosage of medications will be standardized based on formulary indications: IV Ketorolac
           30 mg/dose IVP, acetaminophen 1 gram/dose IV piggy back over 15 minutes every 6 hours,
           ibuprofen 800 mg/dose IV piggy back over 30 minutes every 6 hours.

        4. Variables measured: mean and maximum pain (VAS score at 0 hours, 6 hours, discharge and
           2 weeks post procedure), opioid requirements, mean and maximum nausea (VAS score at 0
           hours, 6 hours, discharge and 2 weeks post procedure), anti-emetic medication
           requirements.

           Weighted sum of pain intensity differences, with pain intensity measured on VAS over 24
           hours (SPID24) will be used as a primary outcome. Satisfaction scores will be measured
           at 24 hours using the validated APS-POQ-R questionnaire (6).

        5. Other variables recorded: Age, height, weight, history of postoperative nausea and
           vomiting or motion sickness, diagnosis, uterine volume, dominant fibroid size, arteries
           embolized, presence of prominent ovarian arteries, volume of particle used, fluoroscopy
           time for the procedure.

        6. Technical parameters, which would remain constant, include: pre procedure and 6 month
           follow up MRI contrast with gadolinium which is standard of care, embolization using
           500-700 micron Embospheres (with limited use of 700-900 micron Embospheres), IV
           hydration with 0.9% normal saline, antibiotics (IV ciprofloxacin 400 mg every 12 hours,
           IV metronidazole 500 mg every six hours), urinary catheter placement, lower extremity
           compression devices, and early ambulation.

        7. In the interim analysis, the investigators will have 40 subjects in total with unequal
           randomization ratio of 1:1:4:4. Additional subjects will be enrolled for a total of 35
           subjects per arm for the final analysis (sum total N=140)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen
time frame: 24 hours
description: Primary efficacy objective is to compare the change in maximum level of pain experienced by patient over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.
measure: Evaluation of Mean Pain Intensity Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen
time frame: 24 hours
description: Primary efficacy objective is to compare the change in mean pain intensity score over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.
measure: Mean Nausea Intensity
time frame: 24 hours
description: Assessment of mean nausea by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.
measure: Opioid Consumption
time frame: 24 hours
description: Mean opioid consumption in morphine equivalents over 24 hours
measure: Anti-Emetic Consumption
time frame: 24 hours
description: Mean dose of anti-emetic medication in milligrams given over 24 hours
measure: Maximum Nausea Intensity
time frame: 24 hours
description: Assessment of maximum level of nausea experienced by patient, by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.
arm group label: Intravenous Ibuprofen
arm group type: Experimental
description: Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4 during uterine fibroid embolization
arm group label: Intravenous acetaminophen
arm group type: Experimental
description: Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 during uterine fibroid embolization
arm group label: IV ibuprofen/IV acetaminophen
arm group type: Experimental
description: Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 during uterine fibroid embolization
arm group label: Intravenous placebo/Intravenous placebo
arm group type: Active Comparator
description: Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 during uterine fibroid embolization
intervention type: Drug
intervention name: IV Ibuprofen
description: Uterine fibroid embolization
arm group label: IV ibuprofen/IV acetaminophen
arm group label: Intravenous Ibuprofen
other name: Uterine artery embolization
intervention type: Drug
intervention name: IV Acetaminophen
description: Uterine fibroid embolization
arm group label: IV ibuprofen/IV acetaminophen
arm group label: Intravenous acetaminophen
other name: Uterine artery embolization
intervention type: Drug
intervention name: Intravenous placebo/Intravenous placebo
description: Uterine fibroid embolization
arm group label: Intravenous placebo/Intravenous placebo
other name: Uterine artery embolization
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: No
last name: Cheryl H Hoffman, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Jonathan S Jahr, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Cheryl Hoffman
investigator title: MD.
mesh term: Leiomyoma
mesh term: Myofibroma
mesh term: Adenomyosis
mesh term: Pain, Procedural
mesh term: Acetaminophen
mesh term: Ibuprofen
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 