<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/NCT02983682</url>
  </required_header>
  <id_info>
    <org_study_id>1000052256</org_study_id>
    <nct_id>NCT02983682</nct_id>
  </id_info>
  <brief_title>Lidocaine Infusions for Chronic Pain in Children</brief_title>
  <official_title>A Pilot Study of the Effectiveness of Lidocaine Infusions for the Management of Chronic Pain in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study to evaluate the efficacy and safety of lidocaine in the management of chronic&#xD;
      pain in children. All participants will receive lidocaine infusion and severity of pain and&#xD;
      degree of chronic-pain related disability will be assessed before and up to 4 weeks after&#xD;
      infusion. Adverse events will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reports have shown that intravenous lidocaine infusions have been effective in relieving&#xD;
      chronic pain that has been resistant to other therapies, with minimal side effects. The&#xD;
      investigators would like to determine whether severity of pain and degree of chronic-pain&#xD;
      related disability could be reduced with lidocaine infusion in children and to understand&#xD;
      whether the dose of lidocaine correlates with blood levels in the same manner as it does in&#xD;
      adults. The investigators will recruit 24 patients aged 8-18 with chronic pain that has not&#xD;
      been relieved by standard therapies. Each patient will receive a lidocaine infusion over 2&#xD;
      hours. Blood will be drawn for lidocaine concentration before the beginning of the infusion,&#xD;
      immediately after and 0.5, 2 and 4 hours after. Severity of pain and degree of disability&#xD;
      will be recorded using a questionnaire measuring pain scores, sleep disruption, social&#xD;
      disruption, physical abilities and school attendance before the infusion, weekly for 2 weeks&#xD;
      and then 4 weeks after. This study will help the investigators better understand the&#xD;
      effectiveness and safety of intravenous lidocaine for chronic pain in children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Score</measure>
    <time_frame>Change from baseline pain score (7 days prior to infusion) at 14 days after completion of infusion</time_frame>
    <description>Pain scores will be measured using the Numeric Rating Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analgesic Requirement</measure>
    <time_frame>Up to seven days prior to lidocaine infusion.</time_frame>
    <description>Participants will record all analgesics used in a pain diary provided by the investigators.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic Requirement</measure>
    <time_frame>Up to one month after lidocaine infusion</time_frame>
    <description>Participants will record all analgesics used in a pain diary provided by the investigators.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>intraoperative</time_frame>
    <description>Participants will be monitored for adverse events including cardiac arrhythmias, hypotension, hypertension, tachycardia, metallic taste, tinnitus, lightheadedness, nausea, vomiting and headache</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sleep</measure>
    <time_frame>Day of the infusion, one week, two weeks and four weeks following the infusion.</time_frame>
    <description>The Adolescent Sleep Wake Scale will be used to assess quantity and quality of sleep.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Interference</measure>
    <time_frame>Day of the infusion, one week, two weeks and four weeks following infusion.</time_frame>
    <description>The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale will be used to measure how pain interferes with the participants activities of daily living</description>
  </other_outcome>
  <other_outcome>
    <measure>School Attendance</measure>
    <time_frame>Week prior to the infusion and at two and four weeks following the infusion.</time_frame>
    <description>Participants will record the number of hours of school attendance where relevant (e.g. no school holidays, no medical appointments).</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Pain, Chronic</condition>
  <arm_group>
    <arm_group_label>Lidocaine Infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will receive intravenous lidocaine infusion of 42 mcg/kg/minute over 2 hours, for a total of 5 mg/kg. No bolus dose will be given.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine Infusion</intervention_name>
    <description>Patients will receive lidocaine infusion of 42 micrograms/kg/minute over tow hours for a total of 5 mg/kg.</description>
    <arm_group_label>Lidocaine Infusion</arm_group_label>
    <other_name>Preservative Free Lidocaine Hydrochloride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed with a chronic pain condition (&gt; 3 months) other conventional medical&#xD;
             therapies (anticonvulsants, tricyclics etc), have not been effective.&#xD;
&#xD;
          2. American Society of Anesthesiologists class 1 or 2&#xD;
&#xD;
          3. Age 8-18 years&#xD;
&#xD;
          4. Ability to understand and use the numeric rating scale to rate their pain and to&#xD;
             understand and answer other questionnaires&#xD;
&#xD;
          5. Negative pregnancy test in participants of child-bearing potential (Females 12 years&#xD;
             of age and older, or menarchal if under 12)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of seizures&#xD;
&#xD;
          2. Known liver or renal disease&#xD;
&#xD;
          3. Patient taking strong CYP1A2 inducers or inhibitors (fluvoxamine, phenytoin,&#xD;
             cimetidine, amiodarone) or beta blockers (propranolol, metoprolol, nadolol)&#xD;
&#xD;
          4. Allergy or sensitivity to lidocaine or other local anesthetic&#xD;
&#xD;
          5. Cardiac conduction anomalies (eg. Heart block, Wolff-Parkinson-White)&#xD;
&#xD;
          6. Serum electrolytes (potassium, sodium, magnesium or calcium) outside of reference&#xD;
             ranges&#xD;
&#xD;
          7. Pregnancy&#xD;
&#xD;
        Withdrawal Criteria&#xD;
&#xD;
          1. Patient or parent/guardian request&#xD;
&#xD;
          2. Refusal to have intravenous access and serum levels drawn&#xD;
&#xD;
          3. Inability to complete pain scores on the questionnaires (paper or electronic) at the&#xD;
             first infusion and weekly for 2 weeks and at one month following infusion&#xD;
&#xD;
          4. Baseline free carnitine concentration &lt; 26 micromoles/L or total carnitine &lt; 32&#xD;
             micromoles/L (reference values from SickKids Department of Pediatric Laboratory&#xD;
             Medicine &quot;Guide to Laboratory Services&quot;)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Isaac, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lisa Isaac, MD</last_name>
    <phone>416-813-6410</phone>
    <email>lisa.isaac@sickkids.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carolyne Pehora, RN</last_name>
    <phone>416-813-7654</phone>
    <phone_ext>202406</phone_ext>
    <email>carolyne.pehora@sickkids.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa Isaac, MD</last_name>
      <phone>416-813-6410</phone>
      <email>lisa.isaac@sickkids.ca</email>
    </contact>
    <contact_backup>
      <last_name>Carolyne Pehora, RN</last_name>
      <phone>416-813-7654</phone>
      <phone_ext>202406</phone_ext>
      <email>carolyne.pehora@sickkids.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>April 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>June 21, 2022</last_update_submitted>
  <last_update_submitted_qc>June 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Lisa Isaac</investigator_full_name>
    <investigator_title>Staff Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>Anesthetics, Local</keyword>
  <keyword>Lidocaine</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Children</keyword>
  <keyword>Adolescents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02983682
org study id: 1000052256
nct id: NCT02983682
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a study to evaluate the efficacy and safety of lidocaine in the management of chronic
      pain in children. All participants will receive lidocaine infusion and severity of pain and
      degree of chronic-pain related disability will be assessed before and up to 4 weeks after
      infusion. Adverse events will be recorded.
Reports have shown that intravenous lidocaine infusions have been effective in relieving
      chronic pain that has been resistant to other therapies, with minimal side effects. The
      investigators would like to determine whether severity of pain and degree of chronic-pain
      related disability could be reduced with lidocaine infusion in children and to understand
      whether the dose of lidocaine correlates with blood levels in the same manner as it does in
      adults. The investigators will recruit 24 patients aged 8-18 with chronic pain that has not
      been relieved by standard therapies. Each patient will receive a lidocaine infusion over 2
      hours. Blood will be drawn for lidocaine concentration before the beginning of the infusion,
      immediately after and 0.5, 2 and 4 hours after. Severity of pain and degree of disability
      will be recorded using a questionnaire measuring pain scores, sleep disruption, social
      disruption, physical abilities and school attendance before the infusion, weekly for 2 weeks
      and then 4 weeks after. This study will help the investigators better understand the
      effectiveness and safety of intravenous lidocaine for chronic pain in children.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain Score
time frame: Change from baseline pain score (7 days prior to infusion) at 14 days after completion of infusion
description: Pain scores will be measured using the Numeric Rating Scale
measure: Analgesic Requirement
time frame: Up to seven days prior to lidocaine infusion.
description: Participants will record all analgesics used in a pain diary provided by the investigators.
measure: Analgesic Requirement
time frame: Up to one month after lidocaine infusion
description: Participants will record all analgesics used in a pain diary provided by the investigators.
measure: Adverse Events
time frame: intraoperative
description: Participants will be monitored for adverse events including cardiac arrhythmias, hypotension, hypertension, tachycardia, metallic taste, tinnitus, lightheadedness, nausea, vomiting and headache
measure: Sleep
time frame: Day of the infusion, one week, two weeks and four weeks following the infusion.
description: The Adolescent Sleep Wake Scale will be used to assess quantity and quality of sleep.
measure: Pain Interference
time frame: Day of the infusion, one week, two weeks and four weeks following infusion.
description: The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale will be used to measure how pain interferes with the participants activities of daily living
measure: School Attendance
time frame: Week prior to the infusion and at two and four weeks following the infusion.
description: Participants will record the number of hours of school attendance where relevant (e.g. no school holidays, no medical appointments).
arm group label: Lidocaine Infusion
arm group type: Experimental
description: All participants will receive intravenous lidocaine infusion of 42 mcg/kg/minute over 2 hours, for a total of 5 mg/kg. No bolus dose will be given.
intervention type: Drug
intervention name: Lidocaine Infusion
description: Patients will receive lidocaine infusion of 42 micrograms/kg/minute over tow hours for a total of 5 mg/kg.
arm group label: Lidocaine Infusion
other name: Preservative Free Lidocaine Hydrochloride
criteria: 
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: No
last name: Lisa Isaac, MD
role: Principal Investigator
affiliation: The Hospital for Sick Children
last name: Lisa Isaac, MD
phone: 416-813-6410
email: lisa.isaac@sickkids.ca
last name: Carolyne Pehora, RN
phone: 416-813-7654
phone ext: 202406
email: carolyne.pehora@sickkids.ca
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Lisa Isaac
investigator title: Staff Anesthesiologist
mesh term: Chronic Pain
mesh term: Lidocaine
sharing ipd: No