<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/NCT01712776</url>
  </required_header>
  <id_info>
    <org_study_id>GEB-01</org_study_id>
    <nct_id>NCT01712776</nct_id>
  </id_info>
  <brief_title>Vapocoolant (Pain Ease) Use for Venipuncture</brief_title>
  <official_title>Prospective, Randomized, Blinded,Comparative Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Venipuncture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gebauer Company</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in&#xD;
      decreasing the pain of venipuncture (&quot;blood draw&quot;)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, blinded, comparator study. This study design is considered&#xD;
      standard for establishing safety and efficacy data. Active treatment vapocoolant spray (Pain&#xD;
      Ease Medium Stream) spray) will be used. There will be a placebo (sterile water) in this&#xD;
      study. The population selected for this study, adults (excluding the very old, &gt; 80 years&#xD;
      old) represents a patient population that may benefit from vapocoolant spray. This is a&#xD;
      patient population that according to the treating health care provider already requires&#xD;
      venipuncture for &quot;blood draw&quot; but not intravenous cannulation. Because venipuncture is a&#xD;
      painful procedure, vapocoolant may confer benefit for the relief of pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)</measure>
    <time_frame>Less than 10 minutes after stream application.</time_frame>
    <description>NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Vapocoolant (Pain Ease Medium Stream )</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nature's Tears Sterile Water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Application of sterile water stream (nature's tears) for 4-10 seconds onto the venipuncture site.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vapocoolant (Pain Ease)</intervention_name>
    <description>Topical stream 4-10 seconds duration to skin.</description>
    <arm_group_label>Vapocoolant (Pain Ease Medium Stream )</arm_group_label>
    <other_name>Pain Ease Stream</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nature's Tears Sterile Water</intervention_name>
    <description>Topical stream 4-10 seconds duration to skin</description>
    <arm_group_label>Nature's Tears Sterile Water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient needing venipuncture (&quot;blood draw') but not intravenous cannulation&#xD;
&#xD;
          -  Adult 18 years and older up to and and including 80 years old&#xD;
&#xD;
          -  Stable patient&#xD;
&#xD;
          -  Mentally competent patient able to understand the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any allergies to the spray components (e.g. 1,1,1,3,3 pentafluoropropane&#xD;
             or 1,1,1,2, tetrafluoroethane )&#xD;
&#xD;
          -  Critically ill or unstable (e.g. sepsis or shock)&#xD;
&#xD;
          -  Extremes of age: geriatric (&gt; 80 years) or pediatric ( &lt; 18 years old)&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Venipuncture site located in area of compromised blood supply. Examples include :&#xD;
             patients with peripheral vascular disease, gangrene, Raynaud's disease, Buerger's&#xD;
             disease.&#xD;
&#xD;
          -  Venipuncture site located in area of insensitive skin; patients with a peripheral&#xD;
             neuropathy including diabetic neuropathy.&#xD;
&#xD;
          -  Patient intolerant of cold or with hypersensitivity to the cold.&#xD;
&#xD;
          -  Patient unable or unwilling to give consent.&#xD;
&#xD;
          -  Prior experience with vapocoolant spray&#xD;
&#xD;
          -  Currently in another research trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharon E. Mace, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Farion KJ, Splinter KL, Newhook K, Gaboury I, Splinter WM. The effect of vapocoolant spray on pain due to intravenous cannulation in children: a randomized controlled trial. CMAJ. 2008 Jul 1;179(1):31-6. doi: 10.1503/cmaj.070874.</citation>
    <PMID>18591524</PMID>
  </reference>
  <reference>
    <citation>Hijazi R, Taylor D, Richardson J. Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial. BMJ. 2009 Feb 10;338:b215. doi: 10.1136/bmj.b215.</citation>
    <PMID>19208703</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <results_first_submitted>January 9, 2014</results_first_submitted>
  <results_first_submitted_qc>December 5, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 11, 2014</results_first_posted>
  <last_update_submitted>January 16, 2017</last_update_submitted>
  <last_update_submitted_qc>January 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Sharon Mace</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Vapocoolant</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>emergency department patients</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo (Normal Saline, Nature&amp;Apos;s Tears)</title>
          <description>Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.&#xD;
Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin.</description>
        </group>
        <group group_id="P2">
          <title>Vapocoolant (Pain Ease Medium Stream )</title>
          <description>Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.&#xD;
Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50">trial to enroll 50 in each group for total of 100</participants>
                <participants group_id="P2" count="50"/>
              </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>
      <population>pain after spray with placebo or vapocoolant</population>
      <group_list>
        <group group_id="B1">
          <title>Vapocoolant (Pain Ease Medium Stream )</title>
          <description>Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.&#xD;
Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin.</description>
        </group>
        <group group_id="B2">
          <title>Nature's Tears</title>
          <description>Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.&#xD;
Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin.</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="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </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="52.98" spread="13.42"/>
                    <measurement group_id="B2" value="51.48" spread="11.48"/>
                    <measurement group_id="B3" value="52.23" spread="12.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)</title>
        <description>NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)</description>
        <time_frame>Less than 10 minutes after stream application.</time_frame>
        <population>equal numbers in both groups by randomization to 50 in each group to look at NRS by change of 2 in NRS scale between the 2 groups</population>
        <group_list>
          <group group_id="O1">
            <title>Vapocoolant (Pain Ease Medium Stream )</title>
            <description>Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.&#xD;
Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin.</description>
          </group>
          <group group_id="O2">
            <title>Nature's Tears</title>
            <description>Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.&#xD;
Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)</title>
          <description>NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)</description>
          <population>equal numbers in both groups by randomization to 50 in each group to look at NRS by change of 2 in NRS scale between the 2 groups</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="2.3"/>
                    <measurement group_id="O2" value="4.7" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 minutes</time_frame>
      <desc>Time frame = the time the patients were in the emergency department Skin assessments were done within 10 minutes after spray application</desc>
      <group_list>
        <group group_id="E1">
          <title>Vapocoolant (Pain Ease Medium Stream )</title>
          <description>Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.&#xD;
Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin.</description>
        </group>
        <group group_id="E2">
          <title>Nature's Tears</title>
          <description>Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.&#xD;
Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin.</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="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>other</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin felt cool</sub_title>
                <description>&quot;skin felt cool&quot; at 10 minutes no skin abnormalities seen</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </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>
    <limitations_and_caveats>This study enrolled only adults. No pediatric patients were enrolled. However, an earlier study by Farion KJ et al in CMAJ in 2008 found that the use of a vapocoolant (pain-ease) significantly decreased the pain of intravenous cannulation in children</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Sharon E. Mace, Director of Research, ESI</name_or_title>
      <organization>Cleveland Clinic</organization>
      <phone>(216) 445-4598</phone>
      <email>maces@ccf.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/NCT01712776
org study id: GEB-01
nct id: NCT01712776
lead sponsor: 
collaborator: 
has dmc: Yes
To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in
      decreasing the pain of venipuncture ("blood draw")
This is a prospective, randomized, blinded, comparator study. This study design is considered
      standard for establishing safety and efficacy data. Active treatment vapocoolant spray (Pain
      Ease Medium Stream) spray) will be used. There will be a placebo (sterile water) in this
      study. The population selected for this study, adults (excluding the very old, > 80 years
      old) represents a patient population that may benefit from vapocoolant spray. This is a
      patient population that according to the treating health care provider already requires
      venipuncture for "blood draw" but not intravenous cannulation. Because venipuncture is a
      painful procedure, vapocoolant may confer benefit for the relief of pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)
time frame: Less than 10 minutes after stream application.
description: NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)
arm group label: Vapocoolant (Pain Ease Medium Stream )
arm group type: Active Comparator
description: Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.
arm group label: Nature's Tears Sterile Water
arm group type: Placebo Comparator
description: Application of sterile water stream (nature's tears) for 4-10 seconds onto the venipuncture site.
intervention type: Device
intervention name: Vapocoolant (Pain Ease)
description: Topical stream 4-10 seconds duration to skin.
arm group label: Vapocoolant (Pain Ease Medium Stream )
other name: Pain Ease Stream
intervention type: Device
intervention name: Nature's Tears Sterile Water
description: Topical stream 4-10 seconds duration to skin
arm group label: Nature's Tears Sterile Water
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sharon E. Mace, M.D.
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
citation: Farion KJ, Splinter KL, Newhook K, Gaboury I, Splinter WM. The effect of vapocoolant spray on pain due to intravenous cannulation in children: a randomized controlled trial. CMAJ. 2008 Jul 1;179(1):31-6. doi: 10.1503/cmaj.070874.
PMID: 18591524
citation: Hijazi R, Taylor D, Richardson J. Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial. BMJ. 2009 Feb 10;338:b215. doi: 10.1136/bmj.b215.
PMID: 19208703
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Sharon Mace
investigator title: Principal Investigator
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study enrolled only adults. No pediatric patients were enrolled. However, an earlier study by Farion KJ et al in CMAJ in 2008 found that the use of a vapocoolant (pain-ease) significantly decreased the pain of intravenous cannulation in children
point of contact: 