<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/NCT03794362</url>
  </required_header>
  <id_info>
    <org_study_id>9586</org_study_id>
    <nct_id>NCT03794362</nct_id>
  </id_info>
  <brief_title>Measuring Analgesic Interventions</brief_title>
  <official_title>Developing a Method to Objectively Measure Analgesic Interventions: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Julia Finkel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's National Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is generally recognized that pain assessment and management especially in newborns,&#xD;
      children and other nonverbal populations is an unmet need. According to the American Medical&#xD;
      Association, &quot;the pediatric population is at risk of inadequate pain management, with&#xD;
      age-related factors affecting pain management in children. Children are often given minimal&#xD;
      or no analgesia for procedures that would routinely be treated aggressively in adults.&#xD;
      Although much is now known about pain management in children, it has not been widely or&#xD;
      effectively translated into routine clinical practice&quot;. These two factors combine to&#xD;
      emphasize the necessity for an objective tool to quantify pain and monitor the effectiveness&#xD;
      of analgesia, especially during treatments. Further, it is reported that many patients&#xD;
      require a combination of treatments, and it is often necessary to test a variety of&#xD;
      treatments before the personal match for treatment is found. The method in place to change&#xD;
      the care on a subjective basis is difficult, time consuming, and not easily individualized.&#xD;
      This pilot study is part of an ongoing effort to develop a method to objectively assess&#xD;
      response to specific analgesic interventions. It specifically aims to discern the impact of&#xD;
      analgesic interventions on sensory nerve fiber sensitivity in a diverse patient population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 29, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pupillary Reflex Dilation (PRD) Area under Curve (AUC)</measure>
    <time_frame>0, 15, 30, 45, 60, 90, 120, 180 minutes</time_frame>
    <description>The changes that occur in PRD AUC as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pupillary Light Reflex (PLR) Latency</measure>
    <time_frame>0, 15, 30, 45, 60, 90, 120, 180 minutes</time_frame>
    <description>The changes that occur in PLR Latency as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pupillary Light Reflex (PLR) Amplitude</measure>
    <time_frame>0, 15, 30, 45, 60, 90, 120, 180 minutes</time_frame>
    <description>The changes that occur in PLR Amplitude as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pupillary Light Reflex (PLR) Recovery Time</measure>
    <time_frame>0, 15, 30, 45, 60, 90, 120, 180 minutes</time_frame>
    <description>The changes that occur in PLR Recovery Time as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pupillary Reflex Dilation (PRD) Amplitude</measure>
    <time_frame>0, 15, 30, 45, 60, 90, 120, 180 minutes</time_frame>
    <description>The changes that occur in PRD amplitude as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.</description>
  </secondary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Local Anesthetics</arm_group_label>
    <description>Lidocaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>N-methyl-D-aspartate Antagonists</arm_group_label>
    <description>Ketamine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SNRIs</arm_group_label>
    <description>Duloxetine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alpha-2 adrenergic agonists</arm_group_label>
    <description>Dexmedetomidine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral Analgesics</arm_group_label>
    <description>NSAIDs, acetaminophen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-pharmacologic interventions</arm_group_label>
    <description>Acupuncture</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are receiving pharmacological or non-pharmacological analgesic interventions&#xD;
        as part of their regularly occurring clinical treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject is 7 to 21 years of age&#xD;
&#xD;
          2. The subject is receiving an analgesic intervention in the Children's National Medical&#xD;
             Center Pain Clinic&#xD;
&#xD;
          3. The subject is willing and able to provide written informed assent/parental consent to&#xD;
             the study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Eye pathology precluding pupillometry&#xD;
&#xD;
          2. Patients who are actively using opioids (history of use acceptable). Rationale:&#xD;
             opioids constrict the pupil, and therefore concomitant opioid use would bias our&#xD;
             results.&#xD;
&#xD;
          3. Subjects who are or may be pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julia C Finkel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's National Health System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julia C Finkel, MD</last_name>
    <phone>2024764867</phone>
    <email>jfinkel@childrensnational.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Children's National Health System</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julia C Finkel, MD</last_name>
      <email>jfinkel@cnmc.org</email>
    </contact>
    <investigator>
      <last_name>Julia C Finkel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>October 31, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Children's National Research Institute</investigator_affiliation>
    <investigator_full_name>Julia Finkel</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>analgesia</keyword>
  <keyword>pain</keyword>
  <keyword>nociception</keyword>
  <keyword>pupillometry</keyword>
  <keyword>analgesic</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/NCT03794362
org study id: 9586
nct id: NCT03794362
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
It is generally recognized that pain assessment and management especially in newborns,
      children and other nonverbal populations is an unmet need. According to the American Medical
      Association, "the pediatric population is at risk of inadequate pain management, with
      age-related factors affecting pain management in children. Children are often given minimal
      or no analgesia for procedures that would routinely be treated aggressively in adults.
      Although much is now known about pain management in children, it has not been widely or
      effectively translated into routine clinical practice". These two factors combine to
      emphasize the necessity for an objective tool to quantify pain and monitor the effectiveness
      of analgesia, especially during treatments. Further, it is reported that many patients
      require a combination of treatments, and it is often necessary to test a variety of
      treatments before the personal match for treatment is found. The method in place to change
      the care on a subjective basis is difficult, time consuming, and not easily individualized.
      This pilot study is part of an ongoing effort to develop a method to objectively assess
      response to specific analgesic interventions. It specifically aims to discern the impact of
      analgesic interventions on sensory nerve fiber sensitivity in a diverse patient population.
observational model: Cohort
time perspective: Prospective
measure: Pupillary Reflex Dilation (PRD) Area under Curve (AUC)
time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes
description: The changes that occur in PRD AUC as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.
measure: Pupillary Light Reflex (PLR) Latency
time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes
description: The changes that occur in PLR Latency as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.
measure: Pupillary Light Reflex (PLR) Amplitude
time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes
description: The changes that occur in PLR Amplitude as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.
measure: Pupillary Light Reflex (PLR) Recovery Time
time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes
description: The changes that occur in PLR Recovery Time as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.
measure: Pupillary Reflex Dilation (PRD) Amplitude
time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes
description: The changes that occur in PRD amplitude as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.
arm group label: Local Anesthetics
description: Lidocaine
arm group label: N-methyl-D-aspartate Antagonists
description: Ketamine
arm group label: SNRIs
description: Duloxetine
arm group label: Alpha-2 adrenergic agonists
description: Dexmedetomidine
arm group label: Oral Analgesics
description: NSAIDs, acetaminophen
arm group label: Non-pharmacologic interventions
description: Acupuncture
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 21 Years
healthy volunteers: No
last name: Julia C Finkel, MD
role: Principal Investigator
affiliation: Children's National Health System
last name: Julia C Finkel, MD
phone: 2024764867
email: jfinkel@childrensnational.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Children's National Research Institute
investigator full name: Julia Finkel
investigator title: Principal Investigator