<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/NCT01664559</url>
  </required_header>
  <id_info>
    <org_study_id>WRHR 5K12001259-12 - toradol</org_study_id>
    <nct_id>NCT01664559</nct_id>
  </id_info>
  <brief_title>Pain Control for Intrauterine Device Placement: A Trial of Ketorolac Prior to Intrauterine Device Placement</brief_title>
  <official_title>Pain Control for Intrauterine Device Placement: A Randomized, Double Blind Control Trial of Ketorolac Prior to Intrauterine Device Placement.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lynn Ngo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intrauterine device (IUD) placement can be painful for patients during and after the&#xD;
      procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly&#xD;
      effective long acting reversible contraception. Currently there are no proven effective&#xD;
      methods for reduction of pain during and after placement of modern IUDs (Mirena IUD and&#xD;
      Paragard IUD). Ketorolac has not been studied in regards to decreasing pain during and after&#xD;
      IUD insertion although it is used by some providers for this purpose. It is a strong NSAID&#xD;
      that is indicated for the treatment of moderate acute pain. In the intramuscular form it has&#xD;
      an analgesia onset of action at 30min, thus may be a plausible option for pain management in&#xD;
      the office setting compared to oral NSAIDs, which have a longer time to onset of analgesia&#xD;
      and have not been proven to be effective in reducing pain associated with IUD placement. The&#xD;
      primary aim of this study is to determine whether ketorolac (Toradol) decreases pain&#xD;
      associated with intrauterine device placement compared to placebo. We hypothesize that&#xD;
      administration of ketorolac 30mg intramuscularly at least 30 minutes prior to IUD insertion&#xD;
      will decrease pain scores by at least 20mm on a visual analog scale at various time points&#xD;
      during IUD insertion when compared to placebo of normal saline injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Modern intrauterine devices are highly effective long acting reversible forms of&#xD;
      contraception. The Mirena IUD is 99.8% effective and the Paragard copper IUD is 99.2%&#xD;
      effective in preventing pregnancy (Zieman 2010). Fear of intrauterine device placement can be&#xD;
      a barrier to obtaining this highly effective form of birth control. The current standard of&#xD;
      care for pain management during and after IUD placement is no medication, as randomized&#xD;
      control trials published to date have limited data regarding use of medications to decrease&#xD;
      pain. There has been one trial to suggest that the use of naproxen with 1% lidocaine&#xD;
      paracervical block compared to paracervical block alone may decrease pain after IUD placement&#xD;
      in primarily nulliparous patients. However, this study was with the much wider and no longer&#xD;
      available Dalkon Shield IUD. In addition, this study did not show any significant decrease in&#xD;
      pain scores during IUD placement (Massey 1974). Studies to evaluate effectiveness of motrin&#xD;
      and misoprostol have shown no significant decrease in pain scores during and after IUD&#xD;
      insertion, although the majority of participants in these studies were multiparous (Jensen&#xD;
      1998, Hubacher 2006, Saav 1997). There is some suggestion that 2% lidocaine gel one minute&#xD;
      prior to IUD insertion may have some decrease in pain, although this study was poorly&#xD;
      designed (Oloto 1996).&#xD;
&#xD;
      There have been no studies published to date regarding the use of ketorolac for decreasing&#xD;
      pain during and after IUD placement. Ketorolac is an acetic acid NSAID that reversibly&#xD;
      inhibits COX 1 and 2, leading to decreased formation of prostaglandin precursors, and is&#xD;
      indicated for the use of moderate acute pain in the short term setting. Its administration in&#xD;
      the office setting may be good option for providers since intramuscular administration leads&#xD;
      to analgesia beginning at 30 minutes, maximal effect 1 to 2 hours after administration, and&#xD;
      duration of analgesia approximately 4 to 6 hours for the 30mg intramuscular injection.&#xD;
&#xD;
      Although there is no standard of care in regards to pain medication administration prior to&#xD;
      IUD placement, providers at UCSD often suggest certain options. These include ibuprofen at&#xD;
      least one hour prior to the procedure, or ibuprofen taken within a few hours after the&#xD;
      procedure, or ketorolac injection at least 15-30 minutes prior to the procedure. It would be&#xD;
      beneficial for providers to have an evidence based option for patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS (Visual Analogue Scale) Measurement of Pain</measure>
    <time_frame>Pain with IUD placement, measured immediately after placement</time_frame>
    <description>The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Scores at Other Time Points During and After IUD Placement</measure>
    <time_frame>immediately after each step (see description)</time_frame>
    <description>The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.&#xD;
Prior to injection of study drug, anticipated pain&#xD;
Pain from study drug injection, measured immediately after injection&#xD;
Pain from speculum insertion, measured immediately after insertion&#xD;
Pain with tenaculum placement, measured immediately after placement&#xD;
Pain with uterine sounding, measured immediately after removal of the sound&#xD;
Pain at 5 minutes after placement of the intrauterine device&#xD;
Pain at 15 minutes after placement of the intrauterine device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nulliparous Patients - Subgroup Analysis</measure>
    <time_frame>immediately after each step (see description)</time_frame>
    <description>The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.&#xD;
Prior to injection of study drug, anticipated pain&#xD;
Pain from study drug injection, measured immediately after injection&#xD;
Pain from speculum insertion, measured immediately after insertion&#xD;
Pain with tenaculum placement, measured immediately after placement&#xD;
Pain with uterine sounding, measured immediately after removal of the sound&#xD;
Pain at 5 minutes after placement of the intrauterine device&#xD;
Pain at 15 minutes after placement of the intrauterine device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-insertion Patient Questionnaire</measure>
    <time_frame>assessed at 15 minutes after IUD insertion</time_frame>
    <description>Questions assessed in multiple choice format:&#xD;
Side effects&#xD;
injection site pain&#xD;
overall satisfaction with IUD insertion experience&#xD;
would they still recommend IUD placement to a friend?&#xD;
significant pain for which they desired acetaminophen prior to leaving the office?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-insertion Provider Questionnaire</measure>
    <time_frame>Immediately after IUD placement, on average within 1 hour</time_frame>
    <description>The provider will be asked to fill out a multiple choice format questionnaire:&#xD;
what level training are you?&#xD;
which IUD was inserted?&#xD;
what was the purpose of IUD placement?&#xD;
what was the position of the uterus?&#xD;
did the IUD placement process require cervical dilation?&#xD;
were you able to complete the IUD insertion?&#xD;
was there bleeding from the cervix that required more than 5 min to control?&#xD;
were there any major complications with the IUD insertion?&#xD;
did the patient take tylenol prior to leaving the office?</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Pain Control With IUD Insertion</condition>
  <arm_group>
    <arm_group_label>Placebo with 1cc normal saline IM</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Toradol, 30mg in 1cc IM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketorolac</intervention_name>
    <description>Ketorolac 30mg intramuscular injection, 1cc volume</description>
    <arm_group_label>Toradol, 30mg in 1cc IM</arm_group_label>
    <other_name>Brand name: toradol</other_name>
    <other_name>Serial # (01) 1 030409 379649 7</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection</description>
    <arm_group_label>Placebo with 1cc normal saline IM</arm_group_label>
    <other_name>REF# 196604</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nulliparous and multiparous women ages 18-50, who are English or Spanish speaking, who&#xD;
             present for intrauterine device placement for contraception or menorrhagia (in the&#xD;
             case of Mirena IUD insertion).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea,&#xD;
             irritable bowel syndrome, interstitial cystitis)&#xD;
&#xD;
          -  If the patient has taken any pain medications within 6 hours of enrollment, including&#xD;
             aspirin or other NSAIDs&#xD;
&#xD;
          -  Misoprostol administration within 24 hours of enrollment&#xD;
&#xD;
          -  History of prior IUD insertion&#xD;
&#xD;
          -  Known allergy to NSAIDs including diagnosis of aspirin or NSAID induced asthma or&#xD;
             urticaria&#xD;
&#xD;
          -  Known contraindications to NSAIDs, such as the following medications that are risk&#xD;
             category D (consider therapy modification) or X (avoid combination) including&#xD;
&#xD;
               -  bile acid sequestrants (D - may decrease absorption of NSAIDs)&#xD;
&#xD;
               -  cyclosporine (D - NSAIDs may enhance the nephrotoxic effects)&#xD;
&#xD;
               -  drotrecogin alfa (D - NSAIDs may enhance the adverse/toxic effects, cause&#xD;
                  bleeding)&#xD;
&#xD;
               -  floctafenine (X - may enhance adverse/toxic effect of NSAIDs)&#xD;
&#xD;
               -  lithium (D - NSAIDs may decrease serum concentration)&#xD;
&#xD;
               -  methotrexate (D - NSAIDs may decrease excretion)&#xD;
&#xD;
               -  pentoxifylline (X - Ketorolac may enhance adverse/toxic effects)&#xD;
&#xD;
               -  probenecid (X - may increase serum concentration of Ketorolac)&#xD;
&#xD;
               -  rivaroxaban (D - Anti-platelet drugs may enhance anti-coagulation effect)&#xD;
&#xD;
               -  SSRIs (D - may enhance the anti-platelet effect of NSAIDs, NSAIDs may diminish&#xD;
                  the therapeutic effect of SSRIs)&#xD;
&#xD;
               -  warfarin (D - NSAIDs may enhance the anti-coagulation effect)&#xD;
&#xD;
          -  Renal insufficiency (by history and/or chart review)&#xD;
&#xD;
          -  Peptic ulcer disease or history of significant gastrointestinal bleeding&#xD;
&#xD;
          -  Known thrombocytopenia, known coagulopathy, or known bleeding disorder&#xD;
&#xD;
          -  Known contraindications to IUD&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lynn L Ngo, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of California, San Diego</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sheila Mody, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007373. doi: 10.1002/14651858.CD007373.pub2.</citation>
    <PMID>19588429</PMID>
  </reference>
  <reference>
    <citation>Roche NE, Li D, James D, Fechner A, Tilak V. The effect of perioperative ketorolac on pain control in pregnancy termination. Contraception. 2012 Mar;85(3):299-303. doi: 10.1016/j.contraception.2011.10.001. Epub 2011 Nov 30.</citation>
    <PMID>22133656</PMID>
  </reference>
  <reference>
    <citation>Edelman AB, Schaefer E, Olson A, Van Houten L, Bednarek P, Leclair C, Jensen JT. Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women. Contraception. 2011 Sep;84(3):234-9. doi: 10.1016/j.contraception.2011.01.016. Epub 2011 Mar 3.</citation>
    <PMID>21843686</PMID>
  </reference>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>June 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <results_first_submitted>July 22, 2015</results_first_submitted>
  <results_first_submitted_qc>November 18, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 23, 2015</results_first_posted>
  <last_update_submitted>November 18, 2015</last_update_submitted>
  <last_update_submitted_qc>November 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Lynn Ngo</investigator_full_name>
    <investigator_title>Resident Physician</investigator_title>
  </responsible_party>
  <keyword>intrauterine device</keyword>
  <keyword>ketorolac</keyword>
  <keyword>toradol</keyword>
  <keyword>mirena</keyword>
  <keyword>paragard</keyword>
  <keyword>pain control</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketorolac</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo With 1cc Normal Saline IM</title>
          <description>If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.&#xD;
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection</description>
        </group>
        <group group_id="P2">
          <title>Toradol, 30mg in 1cc IM</title>
          <description>If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.&#xD;
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="33"/>
              </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>Placebo With 1cc Normal Saline IM</title>
          <description>If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.&#xD;
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection</description>
        </group>
        <group group_id="B2">
          <title>Toradol, 30mg in 1cc IM</title>
          <description>If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.&#xD;
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume</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="34"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="67"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="27.3" spread="5.4"/>
                    <measurement group_id="B2" value="26.6" spread="5.1"/>
                    <measurement group_id="B3" value="26.9" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>female participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian or Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.6" spread="5.7"/>
                    <measurement group_id="B2" value="27.3" spread="5.8"/>
                    <measurement group_id="B3" value="27.4" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gravidity</title>
          <units>pregnancies</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="B2" value="1" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="B3" value="1" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parity</title>
          <units>pregnancies</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="B2" value="1" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="B3" value="1" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Currently breastfeeding</title>
          <description>Not all patients were breastfeeding so this number is not expected to add up to the overall number of baseline participants.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of loop electrosurgical excision procedure</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Level of education</title>
          <description>One participant in the placebo arm did not answer the question about their education status, therefore the sum of the answers for this arm is different than the overall number of baseline participants.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Less than high school</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High school graduate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some college</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>College degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Graduate degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>VAS (Visual Analogue Scale) Measurement of Pain</title>
        <description>The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.</description>
        <time_frame>Pain with IUD placement, measured immediately after placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo With 1cc Normal Saline IM</title>
            <description>If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.&#xD;
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection</description>
          </group>
          <group group_id="O2">
            <title>Toradol, 30mg in 1cc IM</title>
            <description>If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.&#xD;
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume</description>
          </group>
        </group_list>
        <measure>
          <title>VAS (Visual Analogue Scale) Measurement of Pain</title>
          <description>The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" lower_limit="1.2" upper_limit="7.4"/>
                    <measurement group_id="O2" value="3.6" lower_limit="1.5" upper_limit="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.99</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Scores at Other Time Points During and After IUD Placement</title>
        <description>The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.&#xD;
Prior to injection of study drug, anticipated pain&#xD;
Pain from study drug injection, measured immediately after injection&#xD;
Pain from speculum insertion, measured immediately after insertion&#xD;
Pain with tenaculum placement, measured immediately after placement&#xD;
Pain with uterine sounding, measured immediately after removal of the sound&#xD;
Pain at 5 minutes after placement of the intrauterine device&#xD;
Pain at 15 minutes after placement of the intrauterine device</description>
        <time_frame>immediately after each step (see description)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo With 1cc Normal Saline IM</title>
            <description>If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.&#xD;
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection</description>
          </group>
          <group group_id="O2">
            <title>Toradol, 30mg in 1cc IM</title>
            <description>If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.&#xD;
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Scores at Other Time Points During and After IUD Placement</title>
          <description>The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.&#xD;
Prior to injection of study drug, anticipated pain&#xD;
Pain from study drug injection, measured immediately after injection&#xD;
Pain from speculum insertion, measured immediately after insertion&#xD;
Pain with tenaculum placement, measured immediately after placement&#xD;
Pain with uterine sounding, measured immediately after removal of the sound&#xD;
Pain at 5 minutes after placement of the intrauterine device&#xD;
Pain at 15 minutes after placement of the intrauterine device</description>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anticipated pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" lower_limit="1.4" upper_limit="6.5"/>
                    <measurement group_id="O2" value="3.5" lower_limit="1.0" upper_limit="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain with injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.4" upper_limit="2.8"/>
                    <measurement group_id="O2" value="0.6" lower_limit="0.2" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Speculum insertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="0.6" upper_limit="3.7"/>
                    <measurement group_id="O2" value="1.5" lower_limit="0.4" upper_limit="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tenaculum placement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" lower_limit="2.6" upper_limit="5.7"/>
                    <measurement group_id="O2" value="2.5" lower_limit="1.1" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uterine sounding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="2.5" upper_limit="7.5"/>
                    <measurement group_id="O2" value="4.3" lower_limit="1.7" upper_limit="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 min after procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" lower_limit="0.8" upper_limit="3.9"/>
                    <measurement group_id="O2" value="0.3" lower_limit="0" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 min after procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="0.4" upper_limit="3.6"/>
                    <measurement group_id="O2" value="0.1" lower_limit="0" upper_limit="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>1) Anticipated pain</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.31</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>2) pain with injection</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.33</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>3) speculum insertion</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.72</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>4) tenaculum placement</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.36</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>5) uterine sounding</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.64</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>6) 5 min after placement</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>7) 15 min after placement</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nulliparous Patients - Subgroup Analysis</title>
        <description>The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.&#xD;
Prior to injection of study drug, anticipated pain&#xD;
Pain from study drug injection, measured immediately after injection&#xD;
Pain from speculum insertion, measured immediately after insertion&#xD;
Pain with tenaculum placement, measured immediately after placement&#xD;
Pain with uterine sounding, measured immediately after removal of the sound&#xD;
Pain at 5 minutes after placement of the intrauterine device&#xD;
Pain at 15 minutes after placement of the intrauterine device</description>
        <time_frame>immediately after each step (see description)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo With 1cc Normal Saline IM</title>
            <description>If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.&#xD;
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection</description>
          </group>
          <group group_id="O2">
            <title>Toradol, 30mg in 1cc IM</title>
            <description>If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.&#xD;
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume</description>
          </group>
        </group_list>
        <measure>
          <title>Nulliparous Patients - Subgroup Analysis</title>
          <description>The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.&#xD;
Prior to injection of study drug, anticipated pain&#xD;
Pain from study drug injection, measured immediately after injection&#xD;
Pain from speculum insertion, measured immediately after insertion&#xD;
Pain with tenaculum placement, measured immediately after placement&#xD;
Pain with uterine sounding, measured immediately after removal of the sound&#xD;
Pain at 5 minutes after placement of the intrauterine device&#xD;
Pain at 15 minutes after placement of the intrauterine device</description>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1) Anticipated pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="0.8" upper_limit="5.4"/>
                    <measurement group_id="O2" value="3.6" lower_limit="2.0" upper_limit="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2) Pain with injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="0.7" upper_limit="3.4"/>
                    <measurement group_id="O2" value="1.2" lower_limit="0.8" upper_limit="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3) Speculum insertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="1.0" upper_limit="4.5"/>
                    <measurement group_id="O2" value="1.5" lower_limit="0.3" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4) Tenaculum placement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" lower_limit="3.7" upper_limit="7.3"/>
                    <measurement group_id="O2" value="4.3" lower_limit="2.2" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5) Uterine sounding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" lower_limit="6.6" upper_limit="9.2"/>
                    <measurement group_id="O2" value="6.0" lower_limit="3.9" upper_limit="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6) Pain with IUD placement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" lower_limit="7.4" upper_limit="9.0"/>
                    <measurement group_id="O2" value="5.4" lower_limit="5.0" upper_limit="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7) 5 min after placement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" lower_limit="2.3" upper_limit="4.8"/>
                    <measurement group_id="O2" value="2.7" lower_limit="1.5" upper_limit="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8) 15 min after placement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" lower_limit="3.0" upper_limit="6.9"/>
                    <measurement group_id="O2" value="1.8" lower_limit="0.2" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>1) anticipated pain</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>2) pain with injection</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.0</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>3) speculum insertion</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.34</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>4) tenaculum placement</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.32</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>5) uterine sounding</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.04</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>6) IUD placement</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>7) 5 min after placement</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.32</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>8) 15 min after placement</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-insertion Patient Questionnaire</title>
        <description>Questions assessed in multiple choice format:&#xD;
Side effects&#xD;
injection site pain&#xD;
overall satisfaction with IUD insertion experience&#xD;
would they still recommend IUD placement to a friend?&#xD;
significant pain for which they desired acetaminophen prior to leaving the office?</description>
        <time_frame>assessed at 15 minutes after IUD insertion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo With 1cc Normal Saline IM</title>
            <description>If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.&#xD;
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection</description>
          </group>
          <group group_id="O2">
            <title>Toradol, 30mg in 1cc IM</title>
            <description>If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.&#xD;
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume</description>
          </group>
        </group_list>
        <measure>
          <title>Post-insertion Patient Questionnaire</title>
          <description>Questions assessed in multiple choice format:&#xD;
Side effects&#xD;
injection site pain&#xD;
overall satisfaction with IUD insertion experience&#xD;
would they still recommend IUD placement to a friend?&#xD;
significant pain for which they desired acetaminophen prior to leaving the office?</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Reported side effects</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site pain - just as bad/worse than IUD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfied or very satisfied with overall IUD proc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recommend IUD to a friend</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Desires additional pain medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Reported side effects (nausea, vomiting, dyspepsia, headache, dizziness, drowsiness, injection site itchiness, swelling or pain)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&gt; 0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Injection site pain (just as bad or worse than IUD procedure)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.76</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Satisfied or very satisfied with IUD placement procedure</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.76</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Would recommend IUD placement to a friend</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.35</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Desires additional pain medication</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-insertion Provider Questionnaire</title>
        <description>The provider will be asked to fill out a multiple choice format questionnaire:&#xD;
what level training are you?&#xD;
which IUD was inserted?&#xD;
what was the purpose of IUD placement?&#xD;
what was the position of the uterus?&#xD;
did the IUD placement process require cervical dilation?&#xD;
were you able to complete the IUD insertion?&#xD;
was there bleeding from the cervix that required more than 5 min to control?&#xD;
were there any major complications with the IUD insertion?&#xD;
did the patient take tylenol prior to leaving the office?</description>
        <time_frame>Immediately after IUD placement, on average within 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo With 1cc Normal Saline IM</title>
            <description>If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.&#xD;
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection</description>
          </group>
          <group group_id="O2">
            <title>Toradol, 30mg in 1cc IM</title>
            <description>If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.&#xD;
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume</description>
          </group>
        </group_list>
        <measure>
          <title>Post-insertion Provider Questionnaire</title>
          <description>The provider will be asked to fill out a multiple choice format questionnaire:&#xD;
what level training are you?&#xD;
which IUD was inserted?&#xD;
what was the purpose of IUD placement?&#xD;
what was the position of the uterus?&#xD;
did the IUD placement process require cervical dilation?&#xD;
were you able to complete the IUD insertion?&#xD;
was there bleeding from the cervix that required more than 5 min to control?&#xD;
were there any major complications with the IUD insertion?&#xD;
did the patient take tylenol prior to leaving the office?</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Level of training - PGY1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Level of training - PGY2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Level of training - PGY3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Level of training - PGY4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Level of training - Attending</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IUD type - levonogestrel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IUD type - copper</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Purpose of IUD - contraception</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Purpose of IUD - AUB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Position of uterus - anteverted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Position of uterus - retroverted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Position of uterus - midpositioned</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cervical dilation needed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Able to complete the IUD placement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Significant bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Major complications</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Took acetaminophen prior to leaving the office</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Level of training, PGY 1, 2, 3, 4 and Attending</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>IUD type (levonorgestrel or copper)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.09</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Purpose of IUD (contraception or heavy menstrual bleeding)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.0</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Position of uterus (anteverted, retroverted, midpositioned)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.92</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Need for cervical dilation</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.0</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Able to complete the IUD insertion</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.0</p_value>
            <method>Chi-squared, Corrected</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Significant bleeding</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.24</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Major complications</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.0</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Took acetaminophen prior to leaving the office</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Placebo With 1cc Normal Saline IM</title>
          <description>If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.&#xD;
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection</description>
        </group>
        <group group_id="E2">
          <title>Toradol, 30mg in 1cc IM</title>
          <description>If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.&#xD;
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume</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="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </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="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </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>Dr. Lynn Ngo, Lead Study Coordinator/investigator</name_or_title>
      <organization>BWH</organization>
      <phone>(617)732-8798</phone>
      <email>llngo@partners.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/NCT01664559
org study id: WRHR 5K12001259-12 - toradol
nct id: NCT01664559
lead sponsor: 
has dmc: No
Intrauterine device (IUD) placement can be painful for patients during and after the
      procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly
      effective long acting reversible contraception. Currently there are no proven effective
      methods for reduction of pain during and after placement of modern IUDs (Mirena IUD and
      Paragard IUD). Ketorolac has not been studied in regards to decreasing pain during and after
      IUD insertion although it is used by some providers for this purpose. It is a strong NSAID
      that is indicated for the treatment of moderate acute pain. In the intramuscular form it has
      an analgesia onset of action at 30min, thus may be a plausible option for pain management in
      the office setting compared to oral NSAIDs, which have a longer time to onset of analgesia
      and have not been proven to be effective in reducing pain associated with IUD placement. The
      primary aim of this study is to determine whether ketorolac (Toradol) decreases pain
      associated with intrauterine device placement compared to placebo. We hypothesize that
      administration of ketorolac 30mg intramuscularly at least 30 minutes prior to IUD insertion
      will decrease pain scores by at least 20mm on a visual analog scale at various time points
      during IUD insertion when compared to placebo of normal saline injection.
Modern intrauterine devices are highly effective long acting reversible forms of
      contraception. The Mirena IUD is 99.8% effective and the Paragard copper IUD is 99.2%
      effective in preventing pregnancy (Zieman 2010). Fear of intrauterine device placement can be
      a barrier to obtaining this highly effective form of birth control. The current standard of
      care for pain management during and after IUD placement is no medication, as randomized
      control trials published to date have limited data regarding use of medications to decrease
      pain. There has been one trial to suggest that the use of naproxen with 1% lidocaine
      paracervical block compared to paracervical block alone may decrease pain after IUD placement
      in primarily nulliparous patients. However, this study was with the much wider and no longer
      available Dalkon Shield IUD. In addition, this study did not show any significant decrease in
      pain scores during IUD placement (Massey 1974). Studies to evaluate effectiveness of motrin
      and misoprostol have shown no significant decrease in pain scores during and after IUD
      insertion, although the majority of participants in these studies were multiparous (Jensen
      1998, Hubacher 2006, Saav 1997). There is some suggestion that 2% lidocaine gel one minute
      prior to IUD insertion may have some decrease in pain, although this study was poorly
      designed (Oloto 1996).

      There have been no studies published to date regarding the use of ketorolac for decreasing
      pain during and after IUD placement. Ketorolac is an acetic acid NSAID that reversibly
      inhibits COX 1 and 2, leading to decreased formation of prostaglandin precursors, and is
      indicated for the use of moderate acute pain in the short term setting. Its administration in
      the office setting may be good option for providers since intramuscular administration leads
      to analgesia beginning at 30 minutes, maximal effect 1 to 2 hours after administration, and
      duration of analgesia approximately 4 to 6 hours for the 30mg intramuscular injection.

      Although there is no standard of care in regards to pain medication administration prior to
      IUD placement, providers at UCSD often suggest certain options. These include ibuprofen at
      least one hour prior to the procedure, or ibuprofen taken within a few hours after the
      procedure, or ketorolac injection at least 15-30 minutes prior to the procedure. It would be
      beneficial for providers to have an evidence based option for patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: VAS (Visual Analogue Scale) Measurement of Pain
time frame: Pain with IUD placement, measured immediately after placement
description: The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.
measure: Pain Scores at Other Time Points During and After IUD Placement
time frame: immediately after each step (see description)
description: The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.
Prior to injection of study drug, anticipated pain
Pain from study drug injection, measured immediately after injection
Pain from speculum insertion, measured immediately after insertion
Pain with tenaculum placement, measured immediately after placement
Pain with uterine sounding, measured immediately after removal of the sound
Pain at 5 minutes after placement of the intrauterine device
Pain at 15 minutes after placement of the intrauterine device
measure: Nulliparous Patients - Subgroup Analysis
time frame: immediately after each step (see description)
description: The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.
Prior to injection of study drug, anticipated pain
Pain from study drug injection, measured immediately after injection
Pain from speculum insertion, measured immediately after insertion
Pain with tenaculum placement, measured immediately after placement
Pain with uterine sounding, measured immediately after removal of the sound
Pain at 5 minutes after placement of the intrauterine device
Pain at 15 minutes after placement of the intrauterine device
measure: Post-insertion Patient Questionnaire
time frame: assessed at 15 minutes after IUD insertion
description: Questions assessed in multiple choice format:
Side effects
injection site pain
overall satisfaction with IUD insertion experience
would they still recommend IUD placement to a friend?
significant pain for which they desired acetaminophen prior to leaving the office?
measure: Post-insertion Provider Questionnaire
time frame: Immediately after IUD placement, on average within 1 hour
description: The provider will be asked to fill out a multiple choice format questionnaire:
what level training are you?
which IUD was inserted?
what was the purpose of IUD placement?
what was the position of the uterus?
did the IUD placement process require cervical dilation?
were you able to complete the IUD insertion?
was there bleeding from the cervix that required more than 5 min to control?
were there any major complications with the IUD insertion?
did the patient take tylenol prior to leaving the office?
arm group label: Placebo with 1cc normal saline IM
arm group type: Placebo Comparator
description: If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
arm group label: Toradol, 30mg in 1cc IM
arm group type: Experimental
description: If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
intervention type: Drug
intervention name: Ketorolac
description: Ketorolac 30mg intramuscular injection, 1cc volume
arm group label: Toradol, 30mg in 1cc IM
other name: Brand name: toradol
other name: Serial # (01) 1 030409 379649 7
intervention type: Drug
intervention name: Normal Saline
description: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection
arm group label: Placebo with 1cc normal saline IM
other name: REF# 196604
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lynn L Ngo, MD
role: Study Director
affiliation: University of California, San Diego
last name: Sheila Mody, MD MPH
role: Principal Investigator
affiliation: University of California, San Diego
facility: 
country: United States
citation: Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007373. doi: 10.1002/14651858.CD007373.pub2.
PMID: 19588429
citation: Roche NE, Li D, James D, Fechner A, Tilak V. The effect of perioperative ketorolac on pain control in pregnancy termination. Contraception. 2012 Mar;85(3):299-303. doi: 10.1016/j.contraception.2011.10.001. Epub 2011 Nov 30.
PMID: 22133656
citation: Edelman AB, Schaefer E, Olson A, Van Houten L, Bednarek P, Leclair C, Jensen JT. Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women. Contraception. 2011 Sep;84(3):234-9. doi: 10.1016/j.contraception.2011.01.016. Epub 2011 Mar 3.
PMID: 21843686
responsible party type: Sponsor-Investigator
investigator affiliation: University of California, San Diego
investigator full name: Lynn Ngo
investigator title: Resident Physician
mesh term: Ketorolac
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 