<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/NCT03749915</url>
  </required_header>
  <id_info>
    <org_study_id>H18-02364</org_study_id>
    <nct_id>NCT03749915</nct_id>
  </id_info>
  <brief_title>Ametop Compared to Ametop With Pain Ease Spray</brief_title>
  <official_title>A Single Blinded Observational Study of the Effectiveness of a Pain Ease Local Anesthetic Spray, Combined With Ametop Gel, to Reduce the Discomfort of Intravenous Insertion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose to examine if Pain Ease spray, used as an adjunct to the topical&#xD;
      anesthetic Ametop Gel, can improve the percentage of pain-free IV starts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:&#xD;
&#xD;
      The aim of this study is to assess the effectiveness of Pain Ease® spray, used as an adjunct&#xD;
      to Ametop Gel™.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      The investigators hypothesize that using Pain Ease® spray as an adjunct to the standard use&#xD;
      of Ametop Gel™ will increase the number of pain free venipunctures from 30% to 50% or more.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Primary Objective&#xD;
&#xD;
        1. To determine if using Pain Ease® spray as an adjunct to Ametop Gel™ will increase the&#xD;
           number of pain free venipunctures Secondary Objectives&#xD;
&#xD;
        2. To document the side effects of Pain Ease® spray and Ametop Gel™&#xD;
&#xD;
        3. To document the number of attempts for a successful IV insertion&#xD;
&#xD;
      Research Design:&#xD;
&#xD;
      The investigators propose a patient-blinded randomized control trial of Ametop Gel™ with and&#xD;
      without Pain Ease® spray as an adjunct.&#xD;
&#xD;
      Statistical Analysis:&#xD;
&#xD;
      An interim analysis will be performed at the study's halfway point after recruitment of 120&#xD;
      participants. A score on the Faces Pain Scale - Revised (FPS-R) of either 0 or 2 will be&#xD;
      considered a pain-free IV start, while a score of 4-10 will be considered a painful IV&#xD;
      cannula insertion. Fischer's Exact test will be used to determine statistical significance; a&#xD;
      critical alpha of 0.05 will be considered for significance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 20, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain-free IV insertion</measure>
    <time_frame>intraoperative</time_frame>
    <description>The number of pain free IV insertions as measured by participant indicating 0 or 2 on the Faces Pain Scale - Revised.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insertion attempts</measure>
    <time_frame>intraoperative</time_frame>
    <description>Total number of insertion attempts required for successful placement of IV cannula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FPS-R pain score</measure>
    <time_frame>intraoperative</time_frame>
    <description>Mean Faces Pain Scale - Revised pain score by group. 0-10 pain score of 0 being no pain and 10 being most pain ever experienced.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Analgesia</condition>
  <condition>Topical Anesthetic</condition>
  <arm_group>
    <arm_group_label>Comparator: Ametop only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ametop Gel applied as sole topical anesthetic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention: Pain Ease Cold Spray</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pain Ease Cold spray applied immediately before IV insertion, as an adjunct to Ametop Gel.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pain Ease Cold Spray</intervention_name>
    <description>Pain Ease is a spray containing 1,1,1,3,3-Pentafluoropropane (HFC-245fa) and 1,1,1,2-Tetrafluoroethane (HFC-134a). It is a vapocoolant for use as a topical anesthetic.</description>
    <arm_group_label>Intervention: Pain Ease Cold Spray</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ametop</intervention_name>
    <description>Tetracaine Hydrochloride Gel 4%</description>
    <arm_group_label>Comparator: Ametop only</arm_group_label>
    <other_name>Ametop Gel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I &amp; II&#xD;
&#xD;
          -  Elective day case procedure requiring an IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planned IV insertion after inhalation induction&#xD;
&#xD;
          -  Developmental delay or inability to interpret the Revised Faces Pain Scale (FPS-R)10&#xD;
&#xD;
          -  Ametop Gel™ application &lt; 30 minutes before estimated IV start at time of screening&#xD;
&#xD;
          -  Allergies to any of the components in Ametop Gel™, Pain Ease® spray, or adhesives&#xD;
&#xD;
          -  Patients receiving sedative pre-medication&#xD;
&#xD;
          -  Severe Needle phobia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephan Malherbe, FRCA</last_name>
    <role>Principal Investigator</role>
    <affiliation>BC Children's Hospital, Department of Anesthesia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrew Poznikoff, BSc</last_name>
    <phone>604-875-2000</phone>
    <phone_ext>1989</phone_ext>
    <email>andrew.poznikoff@cw.bc.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stephan Malherbe, FRCA</last_name>
    <phone>604-875-2711</phone>
    <email>smalherbe@cw.bc.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>BC Children's Hospital - Department of Anesthesia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4V4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Andrew Poznikoff, BSc</last_name>
      <phone>604-875-2000</phone>
      <phone_ext>1989</phone_ext>
      <email>andrew.poznikoff@cw.bc.ca</email>
    </contact>
    <contact_backup>
      <last_name>Stephan Malherbe, MBBS, FRCA</last_name>
      <phone>604-875-2711</phone>
      <email>smalherbe@cw.bc.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Stephan Malherbe, FRCA</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Louis Scheepers, FRCA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zoe Brown, FRCA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrew Poznikoff, BSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Robert Purdy, FRCA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eleanor Reimer, FRCA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rachelle Scheepers</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://part.bcchr.ca</url>
    <description>Pediatric Anesthesia Research Team website</description>
  </link>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 19, 2018</last_update_submitted>
  <last_update_submitted_qc>November 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Stephan Malherbe</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Pain Ease</keyword>
  <keyword>Ametop Gel</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tetracaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03749915
org study id: H18-02364
nct id: NCT03749915
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The investigators propose to examine if Pain Ease spray, used as an adjunct to the topical
      anesthetic Ametop Gel, can improve the percentage of pain-free IV starts.
Purpose:

      The aim of this study is to assess the effectiveness of Pain Ease® spray, used as an adjunct
      to Ametop Gel™.

      Hypothesis:

      The investigators hypothesize that using Pain Ease® spray as an adjunct to the standard use
      of Ametop Gel™ will increase the number of pain free venipunctures from 30% to 50% or more.

      Objectives:

      Primary Objective

        1. To determine if using Pain Ease® spray as an adjunct to Ametop Gel™ will increase the
           number of pain free venipunctures Secondary Objectives

        2. To document the side effects of Pain Ease® spray and Ametop Gel™

        3. To document the number of attempts for a successful IV insertion

      Research Design:

      The investigators propose a patient-blinded randomized control trial of Ametop Gel™ with and
      without Pain Ease® spray as an adjunct.

      Statistical Analysis:

      An interim analysis will be performed at the study's halfway point after recruitment of 120
      participants. A score on the Faces Pain Scale - Revised (FPS-R) of either 0 or 2 will be
      considered a pain-free IV start, while a score of 4-10 will be considered a painful IV
      cannula insertion. Fischer's Exact test will be used to determine statistical significance; a
      critical alpha of 0.05 will be considered for significance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain-free IV insertion
time frame: intraoperative
description: The number of pain free IV insertions as measured by participant indicating 0 or 2 on the Faces Pain Scale - Revised.
measure: Insertion attempts
time frame: intraoperative
description: Total number of insertion attempts required for successful placement of IV cannula
measure: FPS-R pain score
time frame: intraoperative
description: Mean Faces Pain Scale - Revised pain score by group. 0-10 pain score of 0 being no pain and 10 being most pain ever experienced.
arm group label: Comparator: Ametop only
arm group type: Active Comparator
description: Ametop Gel applied as sole topical anesthetic.
arm group label: Intervention: Pain Ease Cold Spray
arm group type: Experimental
description: Pain Ease Cold spray applied immediately before IV insertion, as an adjunct to Ametop Gel.
intervention type: Device
intervention name: Pain Ease Cold Spray
description: Pain Ease is a spray containing 1,1,1,3,3-Pentafluoropropane (HFC-245fa) and 1,1,1,2-Tetrafluoroethane (HFC-134a). It is a vapocoolant for use as a topical anesthetic.
arm group label: Intervention: Pain Ease Cold Spray
intervention type: Drug
intervention name: Ametop
description: Tetracaine Hydrochloride Gel 4%
arm group label: Comparator: Ametop only
other name: Ametop Gel
criteria: 
gender: All
minimum age: 5 Years
maximum age: 16 Years
healthy volunteers: No
last name: Stephan Malherbe, FRCA
role: Principal Investigator
affiliation: BC Children's Hospital, Department of Anesthesia
last name: Andrew Poznikoff, BSc
phone: 604-875-2000
phone ext: 1989
email: andrew.poznikoff@cw.bc.ca
last name: Stephan Malherbe, FRCA
phone: 604-875-2711
email: smalherbe@cw.bc.ca
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Canada
url: http://part.bcchr.ca
description: Pediatric Anesthesia Research Team website
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Stephan Malherbe
investigator title: Associate Professor
mesh term: Tetracaine
sharing ipd: Undecided