<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/NCT01674075</url>
  </required_header>
  <id_info>
    <org_study_id>2012P001141</org_study_id>
    <nct_id>NCT01674075</nct_id>
  </id_info>
  <brief_title>Lidocaine Serum Levels in Healthy Adult Volunteers: a Pilot Evaluation of the J-Tip Delivery System</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The J-Tip device (National Medical Products, Irvine, CA, USA) is a single-use, needle-free&#xD;
      anesthesia delivery system, approximately 10cm long and weighing 9g that allow for the rapid&#xD;
      delivery of lidocaine hydrochloride prior to peripheral venous access procedures. First&#xD;
      introduced in 2001, it uses compressed carbon dioxide for drug delivery into the subcutaneous&#xD;
      space. J-Tip is now approved by the U.S. Food and Drug Administration (FDA) for both children&#xD;
      and adults.&#xD;
&#xD;
      Designed for patients with needle anxiety and phobia, several clinical trials (Hollingsworth&#xD;
      et al, 2000; Cooper JA et al, 2000) have shown the device to be effective with no significant&#xD;
      untoward effects, including in children as young as 3 years old (Zempsky et al, 2008).&#xD;
      However, two recent cases of toxic serum lidocaine levels in pediatric patients at&#xD;
      Massachusetts General Hospital (MGH) following the use of the J-Tip device is concerning.&#xD;
      Both patients were administered local anesthetic using the J-Tip device prior to needle-stick&#xD;
      and toxicity screens returned with high levels of lidocaine (&gt;6000 mcg/L).&#xD;
&#xD;
      Currently, there is a limited amount of literature available on the safety profile of the&#xD;
      J-Tip Delivery System and no study to date has evaluated serum lidocaine levels following its&#xD;
      use, likely on the assumption that systemic absorption from the small amount of lidocaine&#xD;
      within the device should be negligible. The two pediatric cases highlighted above, seem to&#xD;
      suggest otherwise. The purpose of this pilot study is to assess the safety of the J-Tip&#xD;
      device on a small population of healthy adults and to determine if elevated lidocaine levels&#xD;
      are present systemically or locally. The primary outcome will be lidocaine serum levels&#xD;
      following the administration of the J-Tip device measured at the local site and two distal&#xD;
      sites to establish lidocaine serum levels following J-Tip administration. We expect lidocaine&#xD;
      levels to be undetectable.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum lidocaine concentrations</measure>
    <time_frame>1 hour post J-Tip administration</time_frame>
    <description>To evaluate the safety and pharmacokinetics of the J-Tip Delivery system by measuring serum lidocaine concentrations in healthy adult volunteers.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Healthy adult volunteers</arm_group_label>
    <description>Healthy adult volunteers will be administered a J-Tip to the dorsum of his/her hand.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers over the age of 18.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria-&#xD;
&#xD;
          1. Adults (18-59 years old) without known medical illness&#xD;
&#xD;
          2. Subject has capacity to provide informed consent&#xD;
&#xD;
        Exclusion Criteria-&#xD;
&#xD;
          1. Individuals who have recently received &quot;caine&quot; (dental procedures, topical (orajel) or&#xD;
             hydrocortisone/lidocaine cream) will be excluded from the study&#xD;
&#xD;
          2. History of liver or kidney problems&#xD;
&#xD;
          3. Individuals receiving chemotherapeutic agents&#xD;
&#xD;
          4. Individuals with the PORT-A-CATH® Implantable Vascular Access System&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Padma Gulur, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>July 10, 2013</last_update_submitted>
  <last_update_submitted_qc>July 10, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Padma Gulur, MD</investigator_full_name>
    <investigator_title>Director of Inpatient Pain Services</investigator_title>
  </responsible_party>
  <keyword>safety</keyword>
  <keyword>J-Tip Delivery System</keyword>
  <keyword>pharmacokinetic profile</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01674075
org study id: 2012P001141
nct id: NCT01674075
lead sponsor: 
has dmc: No
The J-Tip device (National Medical Products, Irvine, CA, USA) is a single-use, needle-free
      anesthesia delivery system, approximately 10cm long and weighing 9g that allow for the rapid
      delivery of lidocaine hydrochloride prior to peripheral venous access procedures. First
      introduced in 2001, it uses compressed carbon dioxide for drug delivery into the subcutaneous
      space. J-Tip is now approved by the U.S. Food and Drug Administration (FDA) for both children
      and adults.

      Designed for patients with needle anxiety and phobia, several clinical trials (Hollingsworth
      et al, 2000; Cooper JA et al, 2000) have shown the device to be effective with no significant
      untoward effects, including in children as young as 3 years old (Zempsky et al, 2008).
      However, two recent cases of toxic serum lidocaine levels in pediatric patients at
      Massachusetts General Hospital (MGH) following the use of the J-Tip device is concerning.
      Both patients were administered local anesthetic using the J-Tip device prior to needle-stick
      and toxicity screens returned with high levels of lidocaine (>6000 mcg/L).

      Currently, there is a limited amount of literature available on the safety profile of the
      J-Tip Delivery System and no study to date has evaluated serum lidocaine levels following its
      use, likely on the assumption that systemic absorption from the small amount of lidocaine
      within the device should be negligible. The two pediatric cases highlighted above, seem to
      suggest otherwise. The purpose of this pilot study is to assess the safety of the J-Tip
      device on a small population of healthy adults and to determine if elevated lidocaine levels
      are present systemically or locally. The primary outcome will be lidocaine serum levels
      following the administration of the J-Tip device measured at the local site and two distal
      sites to establish lidocaine serum levels following J-Tip administration. We expect lidocaine
      levels to be undetectable.
observational model: Case-Only
time perspective: Prospective
measure: Serum lidocaine concentrations
time frame: 1 hour post J-Tip administration
description: To evaluate the safety and pharmacokinetics of the J-Tip Delivery system by measuring serum lidocaine concentrations in healthy adult volunteers.
arm group label: Healthy adult volunteers
description: Healthy adult volunteers will be administered a J-Tip to the dorsum of his/her hand.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Padma Gulur, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Padma Gulur, MD
investigator title: Director of Inpatient Pain Services