<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/NCT04500158</url>
  </required_header>
  <id_info>
    <org_study_id>HM20018316</org_study_id>
    <nct_id>NCT04500158</nct_id>
  </id_info>
  <brief_title>The Effect of Local Anesthesia on Control of Intraoperative Physiologic Parameters and Post Operative Comfort</brief_title>
  <official_title>The Effect of Local Anesthesia When Used in Dental Restorative Cases Under General Anesthesia on Control of Intraoperative Physiologic Parameters and Post Operative Comfort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare patient responses during and after surgery when local&#xD;
      anesthetic is used for dental treatment under general anesthesia (GA) and when it is not&#xD;
      used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Local anesthesia is a widely used tool to ensure patient safety and comfort in the dental&#xD;
      office. This is usually accomplished by administering a shot of numbing medicine (local&#xD;
      anesthesia) in different parts of the mouth. Local anesthesia is an important tool used for&#xD;
      care in the dental office however despite its standardized use in dental clinics use of local&#xD;
      anesthetic is not standardized for use in dental cases under GA. In the literature there is&#xD;
      some evidence suggesting that it has some marginal benefit for pain control short term post&#xD;
      operatively and control of vital signs during surgery. Some evidence also suggests that due&#xD;
      to its use there can be increase in post-operative lip chewing and cheek biting due to the&#xD;
      numb sensation. Additionally, it has been seen that due to the numb sensation that children&#xD;
      can be more irritable during when waking up after surgery.&#xD;
&#xD;
      The study section will have 60 participants of which one half will receive local anesthesia&#xD;
      for restorative dental care under GA and the other half will receive conventional no&#xD;
      anesthesia for restorative dental treatment under GA, based on random assignment (like the&#xD;
      flip of a coin). There is an equal chance of being assigned to either group prior to the&#xD;
      consented treatment. Before the surgery, a nurse will access the child's overall pain and&#xD;
      comfort. The study team (faculty, anesthesiologist, and resident) will record the blood&#xD;
      pressure, heart rate, and breathing duration throughout the procedure. After the child has&#xD;
      completed the surgery a nurse will again access the child's overall pain and comfort. Lastly,&#xD;
      parents will be contacted that evening of surgery by a member of the study team to check up&#xD;
      on the child and will be asked some questions to access the child's comfort at home.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 3, 2020</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
  <phase>Phase 3</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain</measure>
    <time_frame>from baseline to post survey, up to 3 hours</time_frame>
    <description>Children will be assessed before and after surgery using the Face, Legs, Activity, Cry, Consolability pain scale (FLACC). The FLACC pain scale rates children's pain based on observations of five domains: face, legs, activity, crying behavior, and consolability. Each domain is rated from 0 to 2 and the scores are summed. The summed scores range from 0 to 10 with higher scores indicating greater discomfort or pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post operative pain</measure>
    <time_frame>in the evening of the day of surgery, up to 10 hours</time_frame>
    <description>Parents will rate their child's pain using the Parent's Postoperative Pain Measure (PPPM). The PPPM is questionnaire which asks parents to indicate yes or no to 15 possible pain related behaviors. The number of yes responses are summed for a score ranging from 0 to 15 with higher scores indicating more pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate</measure>
    <time_frame>baseline to completion of surgery, up to 3 hours</time_frame>
    <description>Heart rate will be assessed throughout the surgical procedure using standard finger pulse oximeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in respiratory rate</measure>
    <time_frame>baseline to completion of surgery, up to 3 hours</time_frame>
    <description>Respiratory rate will be assessed throughout the surgical procedure by the anesthesia machine via sampling line.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in end tidal carbon dioxide</measure>
    <time_frame>baseline to post surgery, up to 3 hours</time_frame>
    <description>The end tidal carbon dioxide will be assessed throughout the surgical procedure by the anesthesia machine via sampling line</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants requiring anesthesiologist intervention</measure>
    <time_frame>baseline to post surgery, up to 3 hours</time_frame>
    <description>Whether intervention by the anesthesiologist is needed during surgery will be coded as 0 for no and 1 for yes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pain, Procedural</condition>
  <arm_group>
    <arm_group_label>Local anesthesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive local anesthesia in addition to the standard care general anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive standard care general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>2% Lidocaine with 1:100,000 epi</description>
    <arm_group_label>Local anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Pediatric patients undergoing GA for dental restorative work at Virginia Commonwealth&#xD;
        University Children's Hospital of Richmond Pavilion and Brook Road Centers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with any sensory or behavioral issues&#xD;
&#xD;
          -  Patients requiring extractions or surgical procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Bortell, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jayakumar Jayaraman, BDS</last_name>
      <phone>804-828-2362</phone>
      <email>jayaramanj@vcu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Tiffany Williams, DDS</last_name>
      <phone>8048282362</phone>
      <email>twilliams25@vcu.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Procedural</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/NCT04500158
org study id: HM20018316
nct id: NCT04500158
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to compare patient responses during and after surgery when local
      anesthetic is used for dental treatment under general anesthesia (GA) and when it is not
      used.
Local anesthesia is a widely used tool to ensure patient safety and comfort in the dental
      office. This is usually accomplished by administering a shot of numbing medicine (local
      anesthesia) in different parts of the mouth. Local anesthesia is an important tool used for
      care in the dental office however despite its standardized use in dental clinics use of local
      anesthetic is not standardized for use in dental cases under GA. In the literature there is
      some evidence suggesting that it has some marginal benefit for pain control short term post
      operatively and control of vital signs during surgery. Some evidence also suggests that due
      to its use there can be increase in post-operative lip chewing and cheek biting due to the
      numb sensation. Additionally, it has been seen that due to the numb sensation that children
      can be more irritable during when waking up after surgery.

      The study section will have 60 participants of which one half will receive local anesthesia
      for restorative dental care under GA and the other half will receive conventional no
      anesthesia for restorative dental treatment under GA, based on random assignment (like the
      flip of a coin). There is an equal chance of being assigned to either group prior to the
      consented treatment. Before the surgery, a nurse will access the child's overall pain and
      comfort. The study team (faculty, anesthesiologist, and resident) will record the blood
      pressure, heart rate, and breathing duration throughout the procedure. After the child has
      completed the surgery a nurse will again access the child's overall pain and comfort. Lastly,
      parents will be contacted that evening of surgery by a member of the study team to check up
      on the child and will be asked some questions to access the child's comfort at home.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in pain
time frame: from baseline to post survey, up to 3 hours
description: Children will be assessed before and after surgery using the Face, Legs, Activity, Cry, Consolability pain scale (FLACC). The FLACC pain scale rates children's pain based on observations of five domains: face, legs, activity, crying behavior, and consolability. Each domain is rated from 0 to 2 and the scores are summed. The summed scores range from 0 to 10 with higher scores indicating greater discomfort or pain.
measure: Post operative pain
time frame: in the evening of the day of surgery, up to 10 hours
description: Parents will rate their child's pain using the Parent's Postoperative Pain Measure (PPPM). The PPPM is questionnaire which asks parents to indicate yes or no to 15 possible pain related behaviors. The number of yes responses are summed for a score ranging from 0 to 15 with higher scores indicating more pain
measure: Change in heart rate
time frame: baseline to completion of surgery, up to 3 hours
description: Heart rate will be assessed throughout the surgical procedure using standard finger pulse oximeter
measure: Change in respiratory rate
time frame: baseline to completion of surgery, up to 3 hours
description: Respiratory rate will be assessed throughout the surgical procedure by the anesthesia machine via sampling line.
measure: Change in end tidal carbon dioxide
time frame: baseline to post surgery, up to 3 hours
description: The end tidal carbon dioxide will be assessed throughout the surgical procedure by the anesthesia machine via sampling line
measure: Number of participants requiring anesthesiologist intervention
time frame: baseline to post surgery, up to 3 hours
description: Whether intervention by the anesthesiologist is needed during surgery will be coded as 0 for no and 1 for yes
arm group label: Local anesthesia
arm group type: Experimental
description: Participants will receive local anesthesia in addition to the standard care general anesthesia
arm group label: Standard care
arm group type: No Intervention
description: Participants will receive standard care general anesthesia
intervention type: Drug
intervention name: Lidocaine
description: 2% Lidocaine with 1:100,000 epi
arm group label: Local anesthesia
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Years
healthy volunteers: No
last name: Elizabeth Bortell, DDS
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Procedural
mesh term: Lidocaine
sharing ipd: No