<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/NCT02205502</url>
  </required_header>
  <id_info>
    <org_study_id>Lidocaine-01</org_study_id>
    <nct_id>NCT02205502</nct_id>
  </id_info>
  <brief_title>Lidocaine as Local Anesthetics in Children Under Ketamine Sedation</brief_title>
  <official_title>Efficacy of Lidocaine as Local Anesthetics in Children Under Procedural Sedation and Analgesia Using Ketamine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ketamine seems an obvious choice in the setting of an emergency department in laceration&#xD;
      repair.&#xD;
&#xD;
      Lidocaine is the local anesthetics widespread used.&#xD;
&#xD;
      Ketamine leads to dissociative amnesia.&#xD;
&#xD;
      Theoretically , lidocaine is not useful in laceration repair using ketamine.&#xD;
&#xD;
      However, lidocaine is used with ketamine in many emergency department.&#xD;
&#xD;
      The investigators compare lidocaine with placebo as an adjunct to ketamine sedation in&#xD;
      children undergoing primary closure&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</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>Children's Hospital of Eastern Ontario Pain Scale (CHEOPS</measure>
    <time_frame>up to 1 hour</time_frame>
    <description>The investigators will measure pain scale of sedated children with the CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) during suturing of lacerated wound.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sedation scale</measure>
    <time_frame>up to 1 hour</time_frame>
    <description>The investigators will measure sedation scale with Ramsey Sedation Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication</measure>
    <time_frame>up to 1 hour</time_frame>
    <description>The investigators will measure complication with continuous oxygen saturation by pulse oximetry (SpO2) and ECG monitoring and record the monitoring result every 5 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of parents and clinicians</measure>
    <time_frame>up to 1 hour</time_frame>
    <description>The investigators will measure Drs. and care givers' satisfaction rate using numeric rating scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">58</enrollment>
  <condition>Conscious Sedation Failure During Procedure</condition>
  <condition>Analgesia</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Proper amount of lidocaine will be injected lacerated wound.&#xD;
dosage form: fluid&#xD;
dosage: not exceeding 1mg/kg&#xD;
frequency: once&#xD;
duration: n/a</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline will be used as a placebo for lidocaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Normal saline will be injected subcutaneously as a placebo for lidocaine in study group of children.</description>
    <arm_group_label>Lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <arm_group_label>Normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who need suturing for laceration under procedural anesthesia using ketamine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication to ketamine and lidocaine&#xD;
&#xD;
          -  patients involved to other studies&#xD;
&#xD;
          -  more or equal to American Society of Anesthesiologist (ASA) class III&#xD;
&#xD;
          -  not alert&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin Hee Lee, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jin Hee Lee,, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jin Hee Lee, Professor</last_name>
    <phone>+82-31-787-7575</phone>
    <email>gienee@snubh.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Hee Lee, Professor</last_name>
      <phone>+82-31-787-7586</phone>
      <email>gienee74@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>June 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>January 6, 2018</last_update_submitted>
  <last_update_submitted_qc>January 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin Hee Lee</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</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/NCT02205502
org study id: Lidocaine-01
nct id: NCT02205502
lead sponsor: 
has dmc: No
Ketamine seems an obvious choice in the setting of an emergency department in laceration
      repair.

      Lidocaine is the local anesthetics widespread used.

      Ketamine leads to dissociative amnesia.

      Theoretically , lidocaine is not useful in laceration repair using ketamine.

      However, lidocaine is used with ketamine in many emergency department.

      The investigators compare lidocaine with placebo as an adjunct to ketamine sedation in
      children undergoing primary closure
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Children's Hospital of Eastern Ontario Pain Scale (CHEOPS
time frame: up to 1 hour
description: The investigators will measure pain scale of sedated children with the CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) during suturing of lacerated wound.
measure: Sedation scale
time frame: up to 1 hour
description: The investigators will measure sedation scale with Ramsey Sedation Scale.
measure: Complication
time frame: up to 1 hour
description: The investigators will measure complication with continuous oxygen saturation by pulse oximetry (SpO2) and ECG monitoring and record the monitoring result every 5 minutes.
measure: Satisfaction of parents and clinicians
time frame: up to 1 hour
description: The investigators will measure Drs. and care givers' satisfaction rate using numeric rating scale
arm group label: Lidocaine
arm group type: Experimental
description: Proper amount of lidocaine will be injected lacerated wound.
dosage form: fluid
dosage: not exceeding 1mg/kg
frequency: once
duration: n/a
arm group label: Normal saline
arm group type: Placebo Comparator
description: Normal saline will be used as a placebo for lidocaine
intervention type: Drug
intervention name: Lidocaine
description: Normal saline will be injected subcutaneously as a placebo for lidocaine in study group of children.
arm group label: Lidocaine
intervention type: Drug
intervention name: Normal saline
arm group label: Normal saline
criteria: 
gender: All
minimum age: 12 Months
maximum age: 10 Years
healthy volunteers: No
last name: Jin Hee Lee, Professor
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
last name: Jin Hee Lee,, Professor
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
last name: Jin Hee Lee, Professor
phone: +82-31-787-7575
email: gienee@snubh.org
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin Hee Lee
investigator title: Assistant Professor
mesh term: Lidocaine