<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/NCT02207855</url>
  </required_header>
  <id_info>
    <org_study_id>IRB14-00231</org_study_id>
    <nct_id>NCT02207855</nct_id>
  </id_info>
  <brief_title>Chloroprocaine for Continuous Epidural Analgesia in Neonates and Infants</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joseph D. Tobias</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This a study to retrospectively review our experience with the use of chloroprocaine for&#xD;
      postoperative epidural infusions in neonates and infants. Pain scores and the need for&#xD;
      intravenous analgesic agents will be recorded from the records to demonstrate the efficacy of&#xD;
      the technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>Every 6 hours for 72 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain medicine consumption</measure>
    <time_frame>Every 6 hours for 72 hours</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">21</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Chloroprocaine</arm_group_label>
    <description>Neonates and infants who have received chloroprocaine for epidural anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chloroprocaine</intervention_name>
    <arm_group_label>Chloroprocaine</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Neonates and infants who have received chloroprocaine for epidural anesthesia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neonates and infants who have received chloroprocaine for epidural anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph D Tobias, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>November 28, 2016</last_update_submitted>
  <last_update_submitted_qc>November 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Joseph D. Tobias</investigator_full_name>
    <investigator_title>Chairman, Dept. of Anesthesiology &amp; Pain Medicine</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chloroprocaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02207855
org study id: IRB14-00231
nct id: NCT02207855
lead sponsor: 
has dmc: No
This a study to retrospectively review our experience with the use of chloroprocaine for
      postoperative epidural infusions in neonates and infants. Pain scores and the need for
      intravenous analgesic agents will be recorded from the records to demonstrate the efficacy of
      the technique.
observational model: Cohort
time perspective: Retrospective
measure: Pain score
time frame: Every 6 hours for 72 hours
measure: Pain medicine consumption
time frame: Every 6 hours for 72 hours
arm group label: Chloroprocaine
description: Neonates and infants who have received chloroprocaine for epidural anesthesia.
intervention type: Drug
intervention name: Chloroprocaine
arm group label: Chloroprocaine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 2 Years
healthy volunteers: No
last name: Joseph D Tobias, MD
role: Principal Investigator
affiliation: Nationwide Children's Hospital
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Joseph D. Tobias
investigator title: Chairman, Dept. of Anesthesiology & Pain Medicine
mesh term: Chloroprocaine