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/NCT06023368</url>
    </required_header>
    <id_info>
      <org_study_id>84569</org_study_id>
      <nct_id>NCT06023368</nct_id>
    </id_info>
    <brief_title>Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray</brief_title>
    <official_title>Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Marianne Hutti</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Bimeco Group</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Kentucky</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 a sterile vapocoolant spray to EMLA cream in&#xD;
        children with access ports.&#xD;
  &#xD;
        Participants will receive either the spray or cream prior to port access and rate pain on a&#xD;
        scale.&#xD;
  &#xD;
        Researchers will compare spray vs cream to see if the spray is as effective as the cream in&#xD;
        reducing pain associated with port puncture.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">February 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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Port Access Pain</measure>
      <time_frame>Within 5 minutes of port access</time_frame>
      <description>Pain will be measured by The Faces Pain Scale - Revised (FPS-R). FPS-R is a self-report measure of pain intensity developed for children. It was adapted from the Faces Pain Scale to make it possible to score the sensation of pain on the widely accepted 0-to-10 metric. Higher scores mean increased pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinic Wait Time</measure>
      <time_frame>Day of visit, up to 8 hours</time_frame>
      <description>Wait time will be measured in minutes from check in to check out</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Duration of Visit</measure>
      <time_frame>Day of visit, up to 8 hours</time_frame>
      <description>Total length of overall appointment time measured in minutes</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">82</enrollment>
    <condition>Pediatric Cancer</condition>
    <arm_group>
      <arm_group_label>Sterile Vapocoolant Spray</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Num vapocoolant spray will be administered as a single use canister around the port</description>
    </arm_group>
    <arm_group>
      <arm_group_label>EMLA Cream</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Numbing (EMLA) cream will be applied around the port.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Num Vapocoolant Spray</intervention_name>
      <description>Spray applied around port prior to access</description>
      <arm_group_label>Sterile Vapocoolant Spray</arm_group_label>
      <other_name>Vapocoolant Spray</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>EMLA Cream</intervention_name>
      <description>cream applied around the port prior to access</description>
      <arm_group_label>EMLA Cream</arm_group_label>
      <other_name>numbing cream</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  English-speaking&#xD;
  &#xD;
            -  Present appointment is for drawing blood, receiving intravenous antibiotics, blood&#xD;
               products, or chemotherapy&#xD;
  &#xD;
            -  EMLA cream has (standard of care) or has not (vapocoolant) been applied to the port&#xD;
               site prior to the appointment&#xD;
  &#xD;
            -  Previous allergic reaction or skin irritation due to EMLA&#xD;
  &#xD;
            -  Quick access to the child's port is needed for drawing blood, or giving treatments,&#xD;
               blood products, or drugs such as chemotherapy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Child has a legal guardian or non-parent family member as the only adult with them for&#xD;
               the visit.&#xD;
  &#xD;
            -  Children less than 4 years of age&#xD;
  &#xD;
            -  Children with altered mental status&#xD;
  &#xD;
            -  History of traumatic brain injury, developmental delay or autism&#xD;
  &#xD;
            -  Child is nonverbal&#xD;
  &#xD;
            -  Present appointment is for drawing blood, receiving intravenous antibiotics, blood&#xD;
               products, or chemotherapy, and child and parents prefer to wait for EMLA cream to take&#xD;
               effect.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marianne Hutti, PhD, APRN</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Kentucky</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kimberly Parks, MSN, RN</last_name>
      <phone>859-562-2511</phone>
      <email>kimberly.parks@uky.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Marianne Hutti, PhD, APRN</last_name>
      <phone>502-523-7649</phone>
      <email>marianne.hutti@uky.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Kentucky DanceBlue Pediatric Hematology/oncology clinic</name>
        <address>
          <city>Lexington</city>
          <state>Kentucky</state>
          <zip>40506</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kimberly Parks, MSN, RN</last_name>
      </contact>
      <contact_backup>
        <last_name>Marianne Hutti, PhD, APRN</last_name>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Kentucky</investigator_affiliation>
      <investigator_full_name>Marianne Hutti</investigator_full_name>
      <investigator_title>Nurse Scientist</investigator_title>
    </responsible_party>
    <keyword>Port access pain</keyword>
    <keyword>pediatric</keyword>
    <keyword>oncology</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lidocaine, Prilocaine Drug Combination</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06023368
  org study id: 84569
  nct id: NCT06023368
  lead sponsor: 
  collaborator: 
  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 a sterile vapocoolant spray to EMLA cream in
        children with access ports.
  
        Participants will receive either the spray or cream prior to port access and rate pain on a
        scale.
  
        Researchers will compare spray vs cream to see if the spray is as effective as the cream in
        reducing pain associated with port puncture.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Port Access Pain
  time frame: Within 5 minutes of port access
  description: Pain will be measured by The Faces Pain Scale - Revised (FPS-R). FPS-R is a self-report measure of pain intensity developed for children. It was adapted from the Faces Pain Scale to make it possible to score the sensation of pain on the widely accepted 0-to-10 metric. Higher scores mean increased pain.
  measure: Clinic Wait Time
  time frame: Day of visit, up to 8 hours
  description: Wait time will be measured in minutes from check in to check out
  measure: Duration of Visit
  time frame: Day of visit, up to 8 hours
  description: Total length of overall appointment time measured in minutes
  arm group label: Sterile Vapocoolant Spray
  arm group type: Experimental
  description: Num vapocoolant spray will be administered as a single use canister around the port
  arm group label: EMLA Cream
  arm group type: Active Comparator
  description: Numbing (EMLA) cream will be applied around the port.
  intervention type: Drug
  intervention name: Num Vapocoolant Spray
  description: Spray applied around port prior to access
  arm group label: Sterile Vapocoolant Spray
  other name: Vapocoolant Spray
  intervention type: Drug
  intervention name: EMLA Cream
  description: cream applied around the port prior to access
  arm group label: EMLA Cream
  other name: numbing cream
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Marianne Hutti, PhD, APRN
  role: Principal Investigator
  affiliation: University of Kentucky
  last name: Kimberly Parks, MSN, RN
  phone: 859-562-2511
  email: kimberly.parks@uky.edu
  last name: Marianne Hutti, PhD, APRN
  phone: 502-523-7649
  email: marianne.hutti@uky.edu
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Kentucky
  investigator full name: Marianne Hutti
  investigator title: Nurse Scientist
  mesh term: Lidocaine, Prilocaine Drug Combination
  sharing ipd: No