<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/NCT01673061</url>
  </required_header>
  <id_info>
    <org_study_id>HN 4405</org_study_id>
    <nct_id>NCT01673061</nct_id>
  </id_info>
  <brief_title>Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage</brief_title>
  <official_title>Vapocoolant Spray as a Novel Local Anesthetic for Cutaneous Abscess Incision and Drainage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Einstein Healthcare Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Albert Einstein Healthcare Network</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cutaneous abscesses (boils) are collections of pus or infection in the skin, and are a&#xD;
      frequent reason for emergency department visits. The only proven cure for abscesses is&#xD;
      cutting them open and allowing the infection to drain, but this procedure is often painful.&#xD;
      Currently, the usual method of pain control is to inject a numbing medication (lidocaine)&#xD;
      into the site, but this injection itself is often painful and sometimes does not offer full&#xD;
      pain relief. Although there has been some research into the use of non-injected numbing&#xD;
      agents as another option, no studies have looked at the use of numbing sprays (vapocoolant)&#xD;
      in this context specifically. The hypothesis of this study is that numbing spray is as good&#xD;
      as injected numbing medication at relieving pain in patients having small abscesses opened&#xD;
      and drained. This theory will be tested by taking two groups of patients having small&#xD;
      abscesses drained in the Emergency Department, and assigning one group to get a numbing&#xD;
      injection, and the other to get a numbing spray. Their levels of pain and satisfaction will&#xD;
      be recorded before, during, and after the procedure, and the two groups will be compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypotheses: Patients would have a similar amount of pain with incision and drainage using&#xD;
      local infiltration of anesthetic as with application of a vapocoolant spray and the pain of&#xD;
      the administration of anesthesia would be similar or reduced with the use of the vapocoolant&#xD;
      spray.&#xD;
&#xD;
      Specific aims: 1.Non-inferiority in pain of anesthesia administration and incision and&#xD;
      drainage of small abscesses by finding no significant difference of patient pain as measured&#xD;
      on the VRNS scale.&#xD;
&#xD;
      2. Show that patients were willing to undergo anesthesia again with a vapocoolant spray as&#xD;
      assesed by the Likert scale Long term goals- To implement the use of vapocoolant sprays as an&#xD;
      alternative form of anesthesia for incision and drainage of abscesses&#xD;
&#xD;
      The primary outcome measure for this study would be the finding of no significant difference&#xD;
      in the pain as measured by the VRNS between the two arms for administration of anesthesia.&#xD;
      Secondary measures would be finding no significant difference in VRNS for incisional and&#xD;
      drainage, and change in VRNS from presentation to anesthesia, and to incision and drainage,&#xD;
      willingness of the patient to choose the allocated sprayin the future, and unexpected events.&#xD;
&#xD;
      Initial medical assessment will be made by an attending/senior resident in accordance with&#xD;
      established clinical procedures, including the history, physical examination, and vital&#xD;
      signs. If by clinical assessment the patients meet eligibility criteria, then they will be&#xD;
      approached by a research associate for screening, informed consent process, enrollment in the&#xD;
      study, and data collection. Following the screening questionnaire, the research associate&#xD;
      will hold thorough discussion about the study. The patients will be given as much time as&#xD;
      they require to understand and make an informed decision. A formal written consent will be&#xD;
      obtained if patients agree to participate. After the patient understands and signs the&#xD;
      informed consent form, they will be randomized to either the placebo group or treatment group&#xD;
      by using a randomization scheme. The treating physician will measure erythema and induration&#xD;
      using a measuring tape, estimate the amount of fluctuance as small, moderate, or large, and&#xD;
      note the location of the abscess. Once randomized, subjects will be given a VRNS scale to&#xD;
      rate their pain upon initial presentation The treating physician will clean the abscess with&#xD;
      chlorhexidine solution then either spray the skin overlying the abscess with&#xD;
      1,1,1,3,3-Pentafluoropropane and 1,1,1,2-Tetrafluoroethane spray (Gebauer's Pain Ease® Medium&#xD;
      Stream Spray) at a distance of 12 cm from the site for a duration of 2 seconds or infiltrate&#xD;
      the abscess with 2% lidocaine with epinepherine (amount determinted by treating physician).&#xD;
      Any reactions to the vapocoolant administration will be noted. The abscess will then be&#xD;
      incised with a No. 11 surgical scalpel, and a cotton tipped applicator will be used to break&#xD;
      up loculations within the abscess cavity. The method of I&amp;D, and decision to probe to&#xD;
      break-up loculations will be standardized, but the degree of probing, and decision to pack&#xD;
      will be left to the discretion of the treating physician. Subjects will be asked by the&#xD;
      research assistant to describe the discomfort of the abscess using the Visual Numerical&#xD;
      Rating Scale (VRNS) during vapocoolant administration, during incision of the abscess, and&#xD;
      after the procedure is complete.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Vapocoolant not effective controlling pain compared with Lidocaine.&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VNRS Pain Scale - Anesthetic Administration</measure>
    <time_frame>Once, on Day 1, at time of anesthetic administration</time_frame>
    <description>Visual Numeric Rating Scale (VNRS) for pain level at time of anesthetic administration on Day 1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VNRS Pain Scale - Incision and Drainage</measure>
    <time_frame>Once, on Day 1, at time of incision and drainage</time_frame>
    <description>Visual Numeric Rating Scale (VNRS) for pain level during incision and drainage of the abscess on Day 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in VNRS - From Pre-anesthesia to Administration of Anesthesia</measure>
    <time_frame>Once, on Day 1</time_frame>
    <description>Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at the moment of anesthesia administration, on Day 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in VNRS - From Pre-anesthesia to Post-procedure</measure>
    <time_frame>Once, on Day 1</time_frame>
    <description>Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at after all aspects of incision and drainage are complete, on Day 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Willingness to Use Method of Anesthesia in the Future</measure>
    <time_frame>Once, on Day 1</time_frame>
    <description>Willingness of the subject to use their assigned method of anesthesia again if they were to require the same procedure in the future. Measured once on Day 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unexpected Events</measure>
    <time_frame>Measured continuosly from consent to discharge, on Day 1.</time_frame>
    <description>Any unexpected events that would occur during study period, including adverse events, on Day 1.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Abscess</condition>
  <arm_group>
    <arm_group_label>Lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vapocoolant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>See associated Arm Description</description>
    <arm_group_label>Lidocaine</arm_group_label>
    <other_name>Lidocaine with Epinephrine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vapocoolant</intervention_name>
    <description>See associated Arm Description</description>
    <arm_group_label>Vapocoolant</arm_group_label>
    <other_name>Gebauer's Pain Ease</other_name>
    <other_name>Numbing Spray</other_name>
    <other_name>1,1,1,3,3-Pentafluoropropane</other_name>
    <other_name>1,1,1,2-Tetrafluoroethane</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Greater than or equal to 18 years old&#xD;
&#xD;
          -  Able to consent&#xD;
&#xD;
          -  Has cutaneous abscess less than or equal to 2 centimeters requiring incision and&#xD;
             drainage in the Emergency Department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years old&#xD;
&#xD;
          -  Unable to consent&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Prisoner or in police custody&#xD;
&#xD;
          -  Known sensitivity to vapocoolant or lidocaine&#xD;
&#xD;
          -  Cold hypersensitivity&#xD;
&#xD;
          -  Chronic steroid use&#xD;
&#xD;
          -  Peripheral neuropathy&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  HIV&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Immunosuppressive state&#xD;
&#xD;
          -  Sickle cell disease&#xD;
&#xD;
          -  Sarcoidosis&#xD;
&#xD;
          -  Abscess greater than 2 centimeters in any dimension&#xD;
&#xD;
          -  Abscess requiring procedural sedation and analgesia for incision and drainage, or&#xD;
             further intervention outside the Emergency Department&#xD;
&#xD;
          -  Abscess located on the hands, feet, face, or perineal areas&#xD;
&#xD;
          -  Pilonidal cyst&#xD;
&#xD;
          -  hidradenitis suppurativa&#xD;
&#xD;
          -  Not a good candidate per attending physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph D'Orazio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein Healthcare Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Albert Einstein Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Singer AJ, Richman PB, Kowalska A, Thode HC Jr. Comparison of patient and practitioner assessments of pain from commonly performed emergency department procedures. Ann Emerg Med. 1999 Jun;33(6):652-8.</citation>
    <PMID>10339680</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>
  <reference>
    <citation>Costello M, Ramundo M, Christopher NC, Powell KR. Ethyl vinyl chloride vapocoolant spray fails to decrease pain associated with intravenous cannulation in children. Clin Pediatr (Phila). 2006 Sep;45(7):628-32. doi: 10.1177/0009922806291013.</citation>
    <PMID>16928840</PMID>
  </reference>
  <reference>
    <citation>Cohen Reis E, Holubkov R. Vapocoolant spray is equally effective as EMLA cream in reducing immunization pain in school-aged children. Pediatrics. 1997 Dec;100(6):E5. doi: 10.1542/peds.100.6.e5.</citation>
    <PMID>9374583</PMID>
  </reference>
  <reference>
    <citation>Mawhorter S, Daugherty L, Ford A, Hughes R, Metzger D, Easley K. Topical vapocoolant quickly and effectively reduces vaccine-associated pain: results of a randomized, single-blinded, placebo-controlled study. J Travel Med. 2004 Sep-Oct;11(5):267-72. doi: 10.2310/7060.2004.19101.</citation>
    <PMID>15544709</PMID>
  </reference>
  <reference>
    <citation>Cannon CR, Replogle B. Fine-needle aspiration biopsy: is anesthesia necessary? Otolaryngol Head Neck Surg. 1999 Apr;120(4):458-9.</citation>
    <PMID>10187933</PMID>
  </reference>
  <reference>
    <citation>Browne J, Awad I, Plant R, McAdoo J, Shorten G. Topical amethocaine (Ametop) is superior to EMLA for intravenous cannulation. Eutectic mixture of local anesthetics. Can J Anaesth. 1999 Nov;46(11):1014-8. doi: 10.1007/BF03013194.</citation>
    <PMID>10566919</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>Rosier EM, Iadarola MJ, Coghill RC. Reproducibility of pain measurement and pain perception. Pain. 2002 Jul;98(1-2):205-16. doi: 10.1016/s0304-3959(02)00048-9.</citation>
    <PMID>12098633</PMID>
  </reference>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>March 6, 2020</results_first_submitted>
  <results_first_submitted_qc>March 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 19, 2020</results_first_posted>
  <last_update_submitted>March 6, 2020</last_update_submitted>
  <last_update_submitted_qc>March 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Abscess</keyword>
  <keyword>Boils</keyword>
  <keyword>Anesthetics, Local</keyword>
  <keyword>Lidocaine</keyword>
  <keyword>Vapocoolant</keyword>
  <keyword>1,1,1,3,3-Pentafluoropropane</keyword>
  <keyword>1,1,1,2-Tetrafluoroethane</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abscess</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Norflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</recruitment_details>
      <pre_assignment_details>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lidocaine</title>
          <description>Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.&#xD;
Lidocaine: See associated Arm Description</description>
        </group>
        <group group_id="P2">
          <title>Vapocoolant</title>
          <description>Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.&#xD;
Vapocoolant: See associated Arm Description</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </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>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</population>
      <group_list>
        <group group_id="B1">
          <title>Lidocaine</title>
          <description>Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.&#xD;
Lidocaine: See associated Arm Description</description>
        </group>
        <group group_id="B2">
          <title>Vapocoolant</title>
          <description>Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.&#xD;
Vapocoolant: See associated Arm Description</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="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <class_list>
            <class>
              <title>United States</title>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>VNRS Pain Scale - Anesthetic Administration</title>
        <description>Visual Numeric Rating Scale (VNRS) for pain level at time of anesthetic administration on Day 1.</description>
        <time_frame>Once, on Day 1, at time of anesthetic administration</time_frame>
        <population>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.&#xD;
Lidocaine: See associated Arm Description</description>
          </group>
          <group group_id="O2">
            <title>Vapocoolant</title>
            <description>Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.&#xD;
Vapocoolant: See associated Arm Description</description>
          </group>
        </group_list>
        <measure>
          <title>VNRS Pain Scale - Anesthetic Administration</title>
          <description>Visual Numeric Rating Scale (VNRS) for pain level at time of anesthetic administration on Day 1.</description>
          <population>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VNRS Pain Scale - Incision and Drainage</title>
        <description>Visual Numeric Rating Scale (VNRS) for pain level during incision and drainage of the abscess on Day 1.</description>
        <time_frame>Once, on Day 1, at time of incision and drainage</time_frame>
        <population>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.&#xD;
Lidocaine: See associated Arm Description</description>
          </group>
          <group group_id="O2">
            <title>Vapocoolant</title>
            <description>Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.&#xD;
Vapocoolant: See associated Arm Description</description>
          </group>
        </group_list>
        <measure>
          <title>VNRS Pain Scale - Incision and Drainage</title>
          <description>Visual Numeric Rating Scale (VNRS) for pain level during incision and drainage of the abscess on Day 1.</description>
          <population>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in VNRS - From Pre-anesthesia to Administration of Anesthesia</title>
        <description>Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at the moment of anesthesia administration, on Day 1.</description>
        <time_frame>Once, on Day 1</time_frame>
        <population>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.&#xD;
Lidocaine: See associated Arm Description</description>
          </group>
          <group group_id="O2">
            <title>Vapocoolant</title>
            <description>Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.&#xD;
Vapocoolant: See associated Arm Description</description>
          </group>
        </group_list>
        <measure>
          <title>Change in VNRS - From Pre-anesthesia to Administration of Anesthesia</title>
          <description>Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at the moment of anesthesia administration, on Day 1.</description>
          <population>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in VNRS - From Pre-anesthesia to Post-procedure</title>
        <description>Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at after all aspects of incision and drainage are complete, on Day 1.</description>
        <time_frame>Once, on Day 1</time_frame>
        <population>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.&#xD;
Lidocaine: See associated Arm Description</description>
          </group>
          <group group_id="O2">
            <title>Vapocoolant</title>
            <description>Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.&#xD;
Vapocoolant: See associated Arm Description</description>
          </group>
        </group_list>
        <measure>
          <title>Change in VNRS - From Pre-anesthesia to Post-procedure</title>
          <description>Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at after all aspects of incision and drainage are complete, on Day 1.</description>
          <population>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Willingness to Use Method of Anesthesia in the Future</title>
        <description>Willingness of the subject to use their assigned method of anesthesia again if they were to require the same procedure in the future. Measured once on Day 1.</description>
        <time_frame>Once, on Day 1</time_frame>
        <population>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.&#xD;
Lidocaine: See associated Arm Description</description>
          </group>
          <group group_id="O2">
            <title>Vapocoolant</title>
            <description>Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.&#xD;
Vapocoolant: See associated Arm Description</description>
          </group>
        </group_list>
        <measure>
          <title>Willingness to Use Method of Anesthesia in the Future</title>
          <description>Willingness of the subject to use their assigned method of anesthesia again if they were to require the same procedure in the future. Measured once on Day 1.</description>
          <population>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Unexpected Events</title>
        <description>Any unexpected events that would occur during study period, including adverse events, on Day 1.</description>
        <time_frame>Measured continuosly from consent to discharge, on Day 1.</time_frame>
        <population>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</population>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.&#xD;
Lidocaine: See associated Arm Description</description>
          </group>
          <group group_id="O2">
            <title>Vapocoolant</title>
            <description>Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.&#xD;
Vapocoolant: See associated Arm Description</description>
          </group>
        </group_list>
        <measure>
          <title>Unexpected Events</title>
          <description>Any unexpected events that would occur during study period, including adverse events, on Day 1.</description>
          <population>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>0</time_frame>
      <desc>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</desc>
      <group_list>
        <group group_id="E1">
          <title>Lidocaine</title>
          <description>Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.&#xD;
Lidocaine: See associated Arm Description</description>
        </group>
        <group group_id="E2">
          <title>Vapocoolant</title>
          <description>Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.&#xD;
Vapocoolant: See associated Arm Description</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kamran Mohiuddin, Director Clinical Research Emergency Medicine</name_or_title>
      <organization>Albert Einstein Medical Center</organization>
      <phone>2154562313</phone>
      <email>mohiuddk@einstein.edu</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/NCT01673061
org study id: HN 4405
nct id: NCT01673061
lead sponsor: 
has dmc: Yes
Cutaneous abscesses (boils) are collections of pus or infection in the skin, and are a
      frequent reason for emergency department visits. The only proven cure for abscesses is
      cutting them open and allowing the infection to drain, but this procedure is often painful.
      Currently, the usual method of pain control is to inject a numbing medication (lidocaine)
      into the site, but this injection itself is often painful and sometimes does not offer full
      pain relief. Although there has been some research into the use of non-injected numbing
      agents as another option, no studies have looked at the use of numbing sprays (vapocoolant)
      in this context specifically. The hypothesis of this study is that numbing spray is as good
      as injected numbing medication at relieving pain in patients having small abscesses opened
      and drained. This theory will be tested by taking two groups of patients having small
      abscesses drained in the Emergency Department, and assigning one group to get a numbing
      injection, and the other to get a numbing spray. Their levels of pain and satisfaction will
      be recorded before, during, and after the procedure, and the two groups will be compared.
Hypotheses: Patients would have a similar amount of pain with incision and drainage using
      local infiltration of anesthetic as with application of a vapocoolant spray and the pain of
      the administration of anesthesia would be similar or reduced with the use of the vapocoolant
      spray.

      Specific aims: 1.Non-inferiority in pain of anesthesia administration and incision and
      drainage of small abscesses by finding no significant difference of patient pain as measured
      on the VRNS scale.

      2. Show that patients were willing to undergo anesthesia again with a vapocoolant spray as
      assesed by the Likert scale Long term goals- To implement the use of vapocoolant sprays as an
      alternative form of anesthesia for incision and drainage of abscesses

      The primary outcome measure for this study would be the finding of no significant difference
      in the pain as measured by the VRNS between the two arms for administration of anesthesia.
      Secondary measures would be finding no significant difference in VRNS for incisional and
      drainage, and change in VRNS from presentation to anesthesia, and to incision and drainage,
      willingness of the patient to choose the allocated sprayin the future, and unexpected events.

      Initial medical assessment will be made by an attending/senior resident in accordance with
      established clinical procedures, including the history, physical examination, and vital
      signs. If by clinical assessment the patients meet eligibility criteria, then they will be
      approached by a research associate for screening, informed consent process, enrollment in the
      study, and data collection. Following the screening questionnaire, the research associate
      will hold thorough discussion about the study. The patients will be given as much time as
      they require to understand and make an informed decision. A formal written consent will be
      obtained if patients agree to participate. After the patient understands and signs the
      informed consent form, they will be randomized to either the placebo group or treatment group
      by using a randomization scheme. The treating physician will measure erythema and induration
      using a measuring tape, estimate the amount of fluctuance as small, moderate, or large, and
      note the location of the abscess. Once randomized, subjects will be given a VRNS scale to
      rate their pain upon initial presentation The treating physician will clean the abscess with
      chlorhexidine solution then either spray the skin overlying the abscess with
      1,1,1,3,3-Pentafluoropropane and 1,1,1,2-Tetrafluoroethane spray (Gebauer's Pain Ease® Medium
      Stream Spray) at a distance of 12 cm from the site for a duration of 2 seconds or infiltrate
      the abscess with 2% lidocaine with epinepherine (amount determinted by treating physician).
      Any reactions to the vapocoolant administration will be noted. The abscess will then be
      incised with a No. 11 surgical scalpel, and a cotton tipped applicator will be used to break
      up loculations within the abscess cavity. The method of I&D, and decision to probe to
      break-up loculations will be standardized, but the degree of probing, and decision to pack
      will be left to the discretion of the treating physician. Subjects will be asked by the
      research assistant to describe the discomfort of the abscess using the Visual Numerical
      Rating Scale (VRNS) during vapocoolant administration, during incision of the abscess, and
      after the procedure is complete.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: VNRS Pain Scale - Anesthetic Administration
time frame: Once, on Day 1, at time of anesthetic administration
description: Visual Numeric Rating Scale (VNRS) for pain level at time of anesthetic administration on Day 1.
measure: VNRS Pain Scale - Incision and Drainage
time frame: Once, on Day 1, at time of incision and drainage
description: Visual Numeric Rating Scale (VNRS) for pain level during incision and drainage of the abscess on Day 1.
measure: Change in VNRS - From Pre-anesthesia to Administration of Anesthesia
time frame: Once, on Day 1
description: Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at the moment of anesthesia administration, on Day 1.
measure: Change in VNRS - From Pre-anesthesia to Post-procedure
time frame: Once, on Day 1
description: Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at after all aspects of incision and drainage are complete, on Day 1.
measure: Willingness to Use Method of Anesthesia in the Future
time frame: Once, on Day 1
description: Willingness of the subject to use their assigned method of anesthesia again if they were to require the same procedure in the future. Measured once on Day 1.
measure: Unexpected Events
time frame: Measured continuosly from consent to discharge, on Day 1.
description: Any unexpected events that would occur during study period, including adverse events, on Day 1.
arm group label: Lidocaine
arm group type: Active Comparator
description: Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.
arm group label: Vapocoolant
arm group type: Active Comparator
description: Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.
intervention type: Drug
intervention name: Lidocaine
description: See associated Arm Description
arm group label: Lidocaine
other name: Lidocaine with Epinephrine
intervention type: Drug
intervention name: Vapocoolant
description: See associated Arm Description
arm group label: Vapocoolant
other name: Gebauer's Pain Ease
other name: Numbing Spray
other name: 1,1,1,3,3-Pentafluoropropane
other name: 1,1,1,2-Tetrafluoroethane
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joseph D'Orazio, MD
role: Principal Investigator
affiliation: Albert Einstein Healthcare Network
facility: 
country: United States
citation: Singer AJ, Richman PB, Kowalska A, Thode HC Jr. Comparison of patient and practitioner assessments of pain from commonly performed emergency department procedures. Ann Emerg Med. 1999 Jun;33(6):652-8.
PMID: 10339680
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: Costello M, Ramundo M, Christopher NC, Powell KR. Ethyl vinyl chloride vapocoolant spray fails to decrease pain associated with intravenous cannulation in children. Clin Pediatr (Phila). 2006 Sep;45(7):628-32. doi: 10.1177/0009922806291013.
PMID: 16928840
citation: Cohen Reis E, Holubkov R. Vapocoolant spray is equally effective as EMLA cream in reducing immunization pain in school-aged children. Pediatrics. 1997 Dec;100(6):E5. doi: 10.1542/peds.100.6.e5.
PMID: 9374583
citation: Mawhorter S, Daugherty L, Ford A, Hughes R, Metzger D, Easley K. Topical vapocoolant quickly and effectively reduces vaccine-associated pain: results of a randomized, single-blinded, placebo-controlled study. J Travel Med. 2004 Sep-Oct;11(5):267-72. doi: 10.2310/7060.2004.19101.
PMID: 15544709
citation: Cannon CR, Replogle B. Fine-needle aspiration biopsy: is anesthesia necessary? Otolaryngol Head Neck Surg. 1999 Apr;120(4):458-9.
PMID: 10187933
citation: Browne J, Awad I, Plant R, McAdoo J, Shorten G. Topical amethocaine (Ametop) is superior to EMLA for intravenous cannulation. Eutectic mixture of local anesthetics. Can J Anaesth. 1999 Nov;46(11):1014-8. doi: 10.1007/BF03013194.
PMID: 10566919
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: Rosier EM, Iadarola MJ, Coghill RC. Reproducibility of pain measurement and pain perception. Pain. 2002 Jul;98(1-2):205-16. doi: 10.1016/s0304-3959(02)00048-9.
PMID: 12098633
responsible party type: Sponsor
mesh term: Abscess
mesh term: Lidocaine
mesh term: Epinephrine
mesh term: Norflurane
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
point of contact: 