xml: <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/NCT05970354</url>
    </required_header>
    <id_info>
      <org_study_id>22-910</org_study_id>
      <nct_id>NCT05970354</nct_id>
    </id_info>
    <brief_title>EMLA Cream as Analgesic for Outpatient Gynecological Procedures</brief_title>
    <official_title>Lidocaine-Prilocaine Cream as Analgesic for Outpatient Gynecological Procedures; A Randomized-Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CAMC Health System</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CAMC Health System</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare pain perception in the study participant&#xD;
        population undergoing the following gynecological procedures: Intra Uterine Device (IUD)&#xD;
        insertion, hysteroscopy, and endometrial biopsy and given either Eutectic Mixture of Local&#xD;
        Anesthetics (EMLA) cream or a placebo. The main question to answer is:&#xD;
  &#xD;
        • Does EMLA cream reduce pain when administered during the following gynecological&#xD;
        procedures: IUD insertion, hysteroscopy, and endometrial biopsy?&#xD;
  &#xD;
        Participants will be asked to do assess their pain on the Visual Analogue Scale through 3&#xD;
        times during the procedure. Researchers will compare the study group with those receiving&#xD;
        placebo group to see if there is a difference in pain scores.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Gynecologic outpatient procedures such as intra-uterine device (IUD) insertion, hysteroscopy&#xD;
        and endometrial biopsies (EMB) have no standard of care for pain management. This has&#xD;
        resulted in acute pain for patients. One local anesthetic, Eutectic Mixture of Local&#xD;
        Anesthetics (EMLA) cream (Lidocaine 2.5%/Prilocaine 2.5%), has shown to decrease perceived&#xD;
        pain during hysteroscopy and IUD placement when compared to a placebo. The purpose of this&#xD;
        study is to evaluate whether EMLA cream reduces pain during the following outpatient&#xD;
        procedures: EMB, hysteroscopy, and IUD placement. Through a randomized control double-blind&#xD;
        trial, study participants will have either 5 grams of EMLA cream or 5 grams of placebo&#xD;
        applied to their cervix 7 minutes prior to the procedure. Patients' intensity of pain will be&#xD;
        assessed using the Visual Analogue Scale (VAS) immediately after speculum placement, during&#xD;
        the procedure, and immediately after completion of the procedure. Pain scores will be&#xD;
        compared between the study and placebo group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analogue Scale Pain Score 1</measure>
      <time_frame>At time of speculum placement for procedure</time_frame>
      <description>Scale of 0-10 on a self-reported pain score</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual Analogue Scale Pain Score 2</measure>
      <time_frame>At start of cervical manipulation</time_frame>
      <description>Scale of 0-10 on a self-reported pain score</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual Analogue Scale Pain Score 3</measure>
      <time_frame>2 minutes after speculum removal</time_frame>
      <description>Scale of 0-10 on a self-reported pain score</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Pain</condition>
    <arm_group>
      <arm_group_label>EMLA Cream</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>5 grams will be applied to patient's cervix 7 minutes before gynecological procedure</description>
    </arm_group>
    <arm_group>
      <arm_group_label>VersaPro Cream</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>5 grams will be applied to patient's cervix 7 minutes before gynecological procedure</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>EMLA Cream</intervention_name>
      <description>Eutectic Mixture of Local Anesthetics (Lidocaine 2.5% and Prilocaine 2.5%)</description>
      <arm_group_label>EMLA Cream</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VersaPro Cream Base for Compounding</intervention_name>
      <description>Placebo</description>
      <arm_group_label>VersaPro Cream</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient will undergo one of the following procedures: intra-uterine device insertion,&#xD;
               hysteroscopy, or endometrial biopsies&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known hypersensitivity to amide anesthetics&#xD;
  &#xD;
            -  Pre-existing methemoglobinemia&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alex Poulsen, DO</last_name>
      <role>Principal Investigator</role>
      <affiliation>West Virginia School of Medicine--Charleston Division</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dara Seybold, MAA</last_name>
      <phone>3049326696</phone>
      <email>djseybold@camc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Cassidy Crews, MPH</last_name>
      <email>cassidy.crews@camc.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Charleston Area Medical Center Institute for Academic Medicine</name>
        <address>
          <city>Charleston</city>
          <state>West Virginia</state>
          <zip>25302</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>intra-uterine device insertion</keyword>
    <keyword>hysteroscopy</keyword>
    <keyword>endometrial biopsy</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lidocaine, Prilocaine Drug Combination</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970354
  org study id: 22-910
  nct id: NCT05970354
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The goal of this clinical trial is to compare pain perception in the study participant
        population undergoing the following gynecological procedures: Intra Uterine Device (IUD)
        insertion, hysteroscopy, and endometrial biopsy and given either Eutectic Mixture of Local
        Anesthetics (EMLA) cream or a placebo. The main question to answer is:
  
        • Does EMLA cream reduce pain when administered during the following gynecological
        procedures: IUD insertion, hysteroscopy, and endometrial biopsy?
  
        Participants will be asked to do assess their pain on the Visual Analogue Scale through 3
        times during the procedure. Researchers will compare the study group with those receiving
        placebo group to see if there is a difference in pain scores.
  Gynecologic outpatient procedures such as intra-uterine device (IUD) insertion, hysteroscopy
        and endometrial biopsies (EMB) have no standard of care for pain management. This has
        resulted in acute pain for patients. One local anesthetic, Eutectic Mixture of Local
        Anesthetics (EMLA) cream (Lidocaine 2.5%/Prilocaine 2.5%), has shown to decrease perceived
        pain during hysteroscopy and IUD placement when compared to a placebo. The purpose of this
        study is to evaluate whether EMLA cream reduces pain during the following outpatient
        procedures: EMB, hysteroscopy, and IUD placement. Through a randomized control double-blind
        trial, study participants will have either 5 grams of EMLA cream or 5 grams of placebo
        applied to their cervix 7 minutes prior to the procedure. Patients' intensity of pain will be
        assessed using the Visual Analogue Scale (VAS) immediately after speculum placement, during
        the procedure, and immediately after completion of the procedure. Pain scores will be
        compared between the study and placebo group.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Visual Analogue Scale Pain Score 1
  time frame: At time of speculum placement for procedure
  description: Scale of 0-10 on a self-reported pain score
  measure: Visual Analogue Scale Pain Score 2
  time frame: At start of cervical manipulation
  description: Scale of 0-10 on a self-reported pain score
  measure: Visual Analogue Scale Pain Score 3
  time frame: 2 minutes after speculum removal
  description: Scale of 0-10 on a self-reported pain score
  arm group label: EMLA Cream
  arm group type: Active Comparator
  description: 5 grams will be applied to patient's cervix 7 minutes before gynecological procedure
  arm group label: VersaPro Cream
  arm group type: Placebo Comparator
  description: 5 grams will be applied to patient's cervix 7 minutes before gynecological procedure
  intervention type: Drug
  intervention name: EMLA Cream
  description: Eutectic Mixture of Local Anesthetics (Lidocaine 2.5% and Prilocaine 2.5%)
  arm group label: EMLA Cream
  intervention type: Drug
  intervention name: VersaPro Cream Base for Compounding
  description: Placebo
  arm group label: VersaPro Cream
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Alex Poulsen, DO
  role: Principal Investigator
  affiliation: West Virginia School of Medicine--Charleston Division
  last name: Dara Seybold, MAA
  phone: 3049326696
  email: djseybold@camc.org
  last name: Cassidy Crews, MPH
  email: cassidy.crews@camc.org
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Lidocaine, Prilocaine Drug Combination