<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/NCT01670487</url>
  </required_header>
  <id_info>
    <org_study_id>GEB-02</org_study_id>
    <nct_id>NCT01670487</nct_id>
  </id_info>
  <brief_title>Vapocoolant (Pain Ease Medium Stream) for Intravenous Lines in Emergency Department Patients</brief_title>
  <official_title>Prospective,Randomized,Blinded, Comparative,Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Intravenous Cannulation in Emergency Department Patients.</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 stream (Pain Ease Medium Stream ) in&#xD;
      decreasing the pain of intravenous cannulation.&#xD;
&#xD;
      To compare vapocoolant stream (Pain Ease medium Stream) with control (e.g. sterile water)&#xD;
      stream.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vapocoolant sprays have been used to decrease the pain associated with painful medical&#xD;
      procedures such as immunizations, needle aspirations, injections, venipuncture and&#xD;
      intravenous cannulation. In general, vapocoolant sprays , have been found to be effective in&#xD;
      decreasing the pain of various medical procedures. Moreover, the use of vapocoolant sprays&#xD;
      ,unlike other local anesthetics , such as infiltrative lidocaine , is not associated with a&#xD;
      painful injection and does affect the success rate of the procedure including intravenous&#xD;
      cannulation and may even increase the success rate of the intravenous cannulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Pain Score on the Numeric Rating Scale (NRS)</measure>
    <time_frame>pain of intravenous catheter placement.</time_frame>
    <description>Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</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 the stream steadily 4 to 10 seconds onto the cannulation site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nature's Tears</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vapocoolant</intervention_name>
    <description>Topical stream of 4 to 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>Sterile water</intervention_name>
    <description>Topical intervention of sterile water stream 4 to 10 seconds to skin.</description>
    <arm_group_label>Nature's Tears</arm_group_label>
    <other_name>Nature's Tears by Bio-Logic Aqua Technologies</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients needing intravenous cannulation&#xD;
&#xD;
          -  Adults age 18 years equal or greater than.&#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.1,1,3,3, pentafluoropropane&#xD;
             or 1,1,1,2 tetrafluoroethane )&#xD;
&#xD;
          -  Critically ill or unstable patient (e.g. sepsis or shock)&#xD;
&#xD;
          -  Infants and children of age , &lt;18 years.&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Intravenous cannulation site located in area of compromised blood supply. (ex:&#xD;
             patients with Peripheral Vascular Disease , Raynaud's disease, gangrene, Buerger's&#xD;
             disease)&#xD;
&#xD;
          -  Intravenous cannulation site located in area of insensitive skin; such as , patients&#xD;
             with a peripheral 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;
      </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>The 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>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>
  <reference>
    <citation>Page DE, Taylor DM. Vapocoolant spray vs subcutaneous lidocaine injection for reducing the pain of intravenous cannulation: a randomized, controlled, clinical trial. Br J Anaesth. 2010 Oct;105(4):519-25. doi: 10.1093/bja/aeq198. Epub 2010 Aug 3.</citation>
    <PMID>20682573</PMID>
  </reference>
  <reference>
    <citation>Biro P, Meier T, Cummins AS. Comparison of topical anaesthesia methods for venous cannulation in adults. Eur J Pain. 1997;1(1):37-42. doi: 10.1016/s1090-3801(97)90051-3.</citation>
    <PMID>15102427</PMID>
  </reference>
  <reference>
    <citation>Hartstein BH, Barry JD. Mitigation of pain during intravenous catheter placement using a topical skin coolant in the emergency department. Emerg Med J. 2008 May;25(5):257-61. doi: 10.1136/emj.2006.044776.</citation>
    <PMID>18434455</PMID>
  </reference>
  <reference>
    <citation>Baxter AL, Leong T, Mathew B. External thermomechanical stimulation versus vapocoolant for adult venipuncture pain: pilot data on a novel device. Clin J Pain. 2009 Oct;25(8):705-10. doi: 10.1097/AJP.0b013e3181af1236.</citation>
    <PMID>19920721</PMID>
  </reference>
  <reference>
    <citation>Patterson P, Hussa AA, Fedele KA, Vegh GL, Hackman CM. Comparison of 4 analgesic agents for venipuncture. AANA J. 2000 Feb;68(1):43-51.</citation>
    <PMID>10876451</PMID>
  </reference>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <results_first_submitted>February 1, 2016</results_first_submitted>
  <results_first_submitted_qc>July 29, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 21, 2016</results_first_posted>
  <last_update_submitted>July 29, 2016</last_update_submitted>
  <last_update_submitted_qc>July 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2016</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>Staff Physician &amp; Research Director, Emergency Services Institute</investigator_title>
  </responsible_party>
  <keyword>Vapocoolant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Vapocoolant (Pain Ease Medium Stream)</title>
          <description>Application of the stream steadily 4 to 10 seconds onto the cannulation site.&#xD;
Vapocoolant: Topical stream of 4 to 10 seconds duration to skin</description>
        </group>
        <group group_id="P2">
          <title>Nature's Tears</title>
          <description>Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.&#xD;
Sterile water: Topical intervention of sterile water stream 4 to 10 seconds 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="150"/>
                <participants group_id="P2" count="150"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="150"/>
                <participants group_id="P2" count="150"/>
              </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>adults undergoing IV annulation in ED</population>
      <group_list>
        <group group_id="B1">
          <title>Vapocoolant (Pain Ease Medium Stream)</title>
          <description>Applied Vapoccolant in a topical stream of 4 to 10 seconds duration to skin</description>
        </group>
        <group group_id="B2">
          <title>Nature's Tears</title>
          <description>Applied Nature's Tears in a topical stream of 4 to 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="150"/>
            <count group_id="B2" value="150"/>
            <count group_id="B3" value="300"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" lower_limit="35" upper_limit="60"/>
                    <measurement group_id="B2" value="50" lower_limit="37" upper_limit="62"/>
                    <measurement group_id="B3" value="51" lower_limit="35" upper_limit="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</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="94"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="158"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Score on the Numeric Rating Scale (NRS)</title>
        <description>Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.</description>
        <time_frame>pain of intravenous catheter placement.</time_frame>
        <population>adults undergoing placement of an intravenous line in the emergency department</population>
        <group_list>
          <group group_id="O1">
            <title>Vapocoolant (Pain Ease Medium Stream)</title>
            <description>Application of the stream steadily 4 to 10 seconds onto the cannulation site.&#xD;
Vapocoolant: Topical stream of 4 to 10 seconds duration to skin</description>
          </group>
          <group group_id="O2">
            <title>Placebo (Nature's Tears)</title>
            <description>Application of the stream steadily for 4 to 10 seconds</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score on the Numeric Rating Scale (NRS)</title>
          <description>Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.</description>
          <population>adults undergoing placement of an intravenous line in the emergency department</population>
          <units>NRS</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="2.4"/>
                    <measurement group_id="O2" value="4.3" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Vapocoolant (Pain Ease Medium Stream)</title>
          <description>Application of the stream steadily 4 to 10 seconds onto the cannulation site.&#xD;
Vapocoolant: Topical stream of 4 to 10 seconds duration to skin</description>
        </group>
        <group group_id="E2">
          <title>Nature's Tears</title>
          <description>Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.&#xD;
Sterile water: Topical intervention of sterile water stream 4 to 10 seconds 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="150"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="16" subjects_at_risk="150"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>skin irritation such as redness or blanching</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="150"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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. Sharon Mace</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/NCT01670487
org study id: GEB-02
nct id: NCT01670487
lead sponsor: 
collaborator: 
has dmc: Yes
To determine the efficacy and safety of vapocoolant stream (Pain Ease Medium Stream ) in
      decreasing the pain of intravenous cannulation.

      To compare vapocoolant stream (Pain Ease medium Stream) with control (e.g. sterile water)
      stream.
Vapocoolant sprays have been used to decrease the pain associated with painful medical
      procedures such as immunizations, needle aspirations, injections, venipuncture and
      intravenous cannulation. In general, vapocoolant sprays , have been found to be effective in
      decreasing the pain of various medical procedures. Moreover, the use of vapocoolant sprays
      ,unlike other local anesthetics , such as infiltrative lidocaine , is not associated with a
      painful injection and does affect the success rate of the procedure including intravenous
      cannulation and may even increase the success rate of the intravenous cannulation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain Score on the Numeric Rating Scale (NRS)
time frame: pain of intravenous catheter placement.
description: Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.
arm group label: Vapocoolant (Pain Ease Medium Stream)
arm group type: Active Comparator
description: Application of the stream steadily 4 to 10 seconds onto the cannulation site.
arm group label: Nature's Tears
arm group type: Placebo Comparator
description: Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.
intervention type: Device
intervention name: Vapocoolant
description: Topical stream of 4 to 10 seconds duration to skin
arm group label: Vapocoolant (Pain Ease Medium Stream)
other name: Pain Ease stream
intervention type: Device
intervention name: Sterile water
description: Topical intervention of sterile water stream 4 to 10 seconds to skin.
arm group label: Nature's Tears
other name: Nature's Tears by Bio-Logic Aqua Technologies
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: 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
citation: Page DE, Taylor DM. Vapocoolant spray vs subcutaneous lidocaine injection for reducing the pain of intravenous cannulation: a randomized, controlled, clinical trial. Br J Anaesth. 2010 Oct;105(4):519-25. doi: 10.1093/bja/aeq198. Epub 2010 Aug 3.
PMID: 20682573
citation: Biro P, Meier T, Cummins AS. Comparison of topical anaesthesia methods for venous cannulation in adults. Eur J Pain. 1997;1(1):37-42. doi: 10.1016/s1090-3801(97)90051-3.
PMID: 15102427
citation: Hartstein BH, Barry JD. Mitigation of pain during intravenous catheter placement using a topical skin coolant in the emergency department. Emerg Med J. 2008 May;25(5):257-61. doi: 10.1136/emj.2006.044776.
PMID: 18434455
citation: Baxter AL, Leong T, Mathew B. External thermomechanical stimulation versus vapocoolant for adult venipuncture pain: pilot data on a novel device. Clin J Pain. 2009 Oct;25(8):705-10. doi: 10.1097/AJP.0b013e3181af1236.
PMID: 19920721
citation: Patterson P, Hussa AA, Fedele KA, Vegh GL, Hackman CM. Comparison of 4 analgesic agents for venipuncture. AANA J. 2000 Feb;68(1):43-51.
PMID: 10876451
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Sharon Mace
investigator title: Staff Physician & Research Director, Emergency Services Institute
mesh term: Emergencies
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 