<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/NCT01701505</url>
  </required_header>
  <id_info>
    <org_study_id>SR 2-03</org_study_id>
    <nct_id>NCT01701505</nct_id>
  </id_info>
  <brief_title>Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects</brief_title>
  <official_title>A Phase 2, Single-Center, Open-Label, Randomized, Parallel-Groups, Dose-Ranging Study to Assess the Efficacy and Safety of Intranasally Administered Kovacaine Mist for Anesthetizing Maxillary Teeth in Pediatric Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Renatus, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Triligent International</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rho, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Renatus, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and safety of intranasally administered&#xD;
      Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center, open-label, randomized, parallel-groups, dose-ranging study to&#xD;
      assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing&#xD;
      maxillary teeth in pediatric subjects.&#xD;
&#xD;
      The study will employ an open-label design to determine the lowest effective doses (LEDs),&#xD;
      and assess the safety and efficacy of Kovacaine Mist administered intranasally for inducing&#xD;
      pulpal anesthesia of maxillary primary teeth numbers A to J and maxillary permanent teeth&#xD;
      numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar)&#xD;
      sufficient to allow completion of the Study Dental Procedure, and will be carried out in&#xD;
      healthy children of either sex between the ages of 3 and 17 years, inclusive.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>Phase 2</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.</measure>
    <time_frame>at 14 minutes with a 3 minute window</time_frame>
    <description>If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Naris Examination (NE) to Assess Reactions to the Study Drug.</measure>
    <time_frame>At Baseline and 120 Minutes</time_frame>
    <description>The principal investigator will perform a visual inspection to note number of participants at post-dose that have a ulceration, inflammation or minor bleeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>At Baseline, 12 minutes, and 120 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure</measure>
    <time_frame>At Baseline, 12 minutes, and 120 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>At Baseline, 12 minutes, and 120 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen Saturation</measure>
    <time_frame>At Baseline, 12 minutes, and 120 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events by Dose Level and Age</measure>
    <time_frame>from baseline to 24 hours following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events by Dose Level Regardless of Age</measure>
    <time_frame>from baseline to 24 hours following drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Kovacaine Mist High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>400uL of Kovacaine Mist, as 2 sprays of 200uL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kovacaine Mist Mid Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200uL of Kovacaine Mist, as 2 sprays of 100uL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kovacaine Mist Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>120uL of Kovacaine Mist, as 2 sprays of 60uL.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>400uL of Kovacaine Mist</intervention_name>
    <description>2 unilateral intranasal sprays of 200uL each.</description>
    <arm_group_label>Kovacaine Mist High Dose</arm_group_label>
    <other_name>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>200uL of Kovacaine Mist</intervention_name>
    <description>2 unilateral intranasal sprays of 100uL each.</description>
    <arm_group_label>Kovacaine Mist Mid Dose</arm_group_label>
    <other_name>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>120uL of Kovacaine Mist</intervention_name>
    <description>2 unilateral intranasal sprays of 60uL each.</description>
    <arm_group_label>Kovacaine Mist Low Dose</arm_group_label>
    <other_name>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female 3-17 years of age inclusive.&#xD;
&#xD;
          -  Need for an operative restorative dental procedure on a single vital maxillary primary&#xD;
             tooth (#A to J) or permanent tooth (#4 to13), other than a maxillary permanent first,&#xD;
             second or third molar, requiring local anesthesia with an expected treatment duration&#xD;
             not exceeding 60 minutes.&#xD;
&#xD;
          -  Normal lip, nose, eyelid, and cheek sensation.&#xD;
&#xD;
          -  Accompanied and/or represented by a parent or guardian able to comprehend and sign the&#xD;
             informed consent document.&#xD;
&#xD;
          -  If age 8 and above, able to understand and provide informed assent.&#xD;
&#xD;
          -  Patient or parent/guardian able to communicate with the investigator and comply with&#xD;
             the requirements of the protocol.&#xD;
&#xD;
          -  Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.&#xD;
&#xD;
          -  Minimum weight: Subjects in Cohorts A and B (age 6 and above) must weigh at least 20kg&#xD;
             (44 lb.). Subjects in Cohort C (age 3 and above) must weigh at least 10kg (22 lb.).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dental care requiring a local anesthetic within the 24 hours prior to anticipated&#xD;
             study participation.&#xD;
&#xD;
          -  History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local&#xD;
             anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).&#xD;
&#xD;
          -  History of allergy or hypersensitivity to lidocaine, oxymetazoline, epinephrine, or&#xD;
             sulfite preservatives.&#xD;
&#xD;
          -  Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.&#xD;
&#xD;
          -  Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females&#xD;
             of child-bearing potential will be required to take a urine pregnancy test on the day&#xD;
             of, but prior to, study drug administration to rule out pregnancy.)&#xD;
&#xD;
          -  Inadequately controlled thyroid disease of any type.&#xD;
&#xD;
          -  Use of any investigational drug (including Kovacaine Mist) and/or participation in any&#xD;
             clinical trial within 30 days of study participation.&#xD;
&#xD;
          -  Frequent nose bleeds (≥ 5 per month).&#xD;
&#xD;
          -  Anticipated need for use of oxymetazoline or phenylephrine nasal spray, nasal&#xD;
             irrigation, or other nasal or oral decongestant on the day of the study procedure.&#xD;
&#xD;
          -  History of congenital or idiopathic methemoglobinemia.&#xD;
&#xD;
          -  Clinically relevant history of sinus/nasal surgery, recent epistaxis, nasal congestion&#xD;
             or sinus infections, or use of a &quot;sinus medication&quot; within the 48 hours prior to&#xD;
             anticipated study participation.&#xD;
&#xD;
          -  History of alcoholism and/or drug abuse.&#xD;
&#xD;
          -  Pulpal pathology in the index tooth.&#xD;
&#xD;
          -  Anticipated need for use of nitrous oxide before or during the Study Dental Procedure.&#xD;
&#xD;
          -  Any chronic or currently uncontrolled psychogenic, neurological, endocrine, pulmonary,&#xD;
             cardiovascular, renal, gastrointestinal or hepatic disease or condition with&#xD;
             manifestations that might confound interpretation of study results or make receipt of&#xD;
             study medication a source of risk for adverse outcome.&#xD;
&#xD;
          -  Fever defined as body temperature ≥100° (37°C) on the day of and prior to study drug&#xD;
             administration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul A. Moore, DMD/PhD/MPH</last_name>
    <role>Study Director</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Big Grins</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80525</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <results_first_submitted>November 8, 2016</results_first_submitted>
  <results_first_submitted_qc>July 28, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 30, 2017</results_first_posted>
  <disposition_first_submitted>May 15, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>May 15, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">June 8, 2015</disposition_first_posted>
  <last_update_submitted>July 28, 2017</last_update_submitted>
  <last_update_submitted_qc>July 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>operative</keyword>
  <keyword>dental procedure</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phenylephrine</mesh_term>
    <mesh_term>Oxymetazoline</mesh_term>
    <mesh_term>Tetracaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)</title>
          <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each.</description>
        </group>
        <group group_id="P2">
          <title>Cohort A: 12-17 Years Mid-Dose (200uL Kovacaine Mist)</title>
          <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each.</description>
        </group>
        <group group_id="P3">
          <title>Cohort A: 12-17 Years HighDose (400uL Kovacaine Mist)</title>
          <description>400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each.</description>
        </group>
        <group group_id="P4">
          <title>Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)</title>
          <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
        </group>
        <group group_id="P5">
          <title>Cohort B: 7-11 Years Med Dose</title>
          <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
        </group>
        <group group_id="P6">
          <title>Cohort C: 3-6 Years Low Dose</title>
          <description>120uL of Kovacaine Mist, as 2 sprays of 60uL&#xD;
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="8"/>
                <participants group_id="P6" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="8"/>
                <participants group_id="P6" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)</title>
          <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
        </group>
        <group group_id="B2">
          <title>Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)</title>
          <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
        </group>
        <group group_id="B3">
          <title>Cohort A: 12-17 High Dose (400uL Kovacaine Mist)</title>
          <description>400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each</description>
        </group>
        <group group_id="B4">
          <title>Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)</title>
          <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
        </group>
        <group group_id="B5">
          <title>Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)</title>
          <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
        </group>
        <group group_id="B6">
          <title>Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)</title>
          <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
        </group>
        <group group_id="B7">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="8"/>
            <count group_id="B5" value="8"/>
            <count group_id="B6" value="8"/>
            <count group_id="B7" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.3" spread="1.75"/>
                    <measurement group_id="B2" value="14.4" spread="2.00"/>
                    <measurement group_id="B3" value="13.6" spread="1.19"/>
                    <measurement group_id="B4" value="8.9" spread="1.64"/>
                    <measurement group_id="B5" value="7.9" spread="0.83"/>
                    <measurement group_id="B6" value="5.3" spread="1.04"/>
                    <measurement group_id="B7" value="10.7" spread="3.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.</title>
        <description>If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.</description>
        <time_frame>at 14 minutes with a 3 minute window</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)</title>
            <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
          </group>
          <group group_id="O3">
            <title>Cohort A: 12-17 High Dose (400uL Kovacaine Mist)</title>
            <description>400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
          <group group_id="O5">
            <title>Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)</title>
            <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
          </group>
          <group group_id="O6">
            <title>Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.</title>
          <description>If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Naris Examination (NE) to Assess Reactions to the Study Drug.</title>
        <description>The principal investigator will perform a visual inspection to note number of participants at post-dose that have a ulceration, inflammation or minor bleeding.</description>
        <time_frame>At Baseline and 120 Minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)</title>
            <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
          </group>
          <group group_id="O3">
            <title>Cohort A: 12-17 High Dose (400uL Kovacaine Mist)</title>
            <description>400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
          <group group_id="O5">
            <title>Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)</title>
            <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
          </group>
          <group group_id="O6">
            <title>Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
        </group_list>
        <measure>
          <title>Naris Examination (NE) to Assess Reactions to the Study Drug.</title>
          <description>The principal investigator will perform a visual inspection to note number of participants at post-dose that have a ulceration, inflammation or minor bleeding.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-dose ulceration (not present at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-dose inflammation (not present at baseli</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-dose minor bleeding (not present at baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Systolic Blood Pressure</title>
        <time_frame>At Baseline, 12 minutes, and 120 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)</title>
            <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
          </group>
          <group group_id="O3">
            <title>Cohort A: 12-17 High Dose (400uL Kovacaine Mist)</title>
            <description>400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
          <group group_id="O5">
            <title>Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)</title>
            <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
          </group>
          <group group_id="O6">
            <title>Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113.1" spread="8.44"/>
                    <measurement group_id="O2" value="122.5" spread="11.41"/>
                    <measurement group_id="O3" value="115.4" spread="10.06"/>
                    <measurement group_id="O4" value="111.3" spread="7.59"/>
                    <measurement group_id="O5" value="106.5" spread="9.35"/>
                    <measurement group_id="O6" value="97.8" spread="8.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119.1" spread="12.19"/>
                    <measurement group_id="O2" value="122.3" spread="10.89"/>
                    <measurement group_id="O3" value="121.0" spread="21.21"/>
                    <measurement group_id="O4" value="105.5" spread="13.32"/>
                    <measurement group_id="O5" value="109.9" spread="6.53"/>
                    <measurement group_id="O6" value="101.9" spread="10.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120.5" spread="9.27"/>
                    <measurement group_id="O2" value="120.1" spread="10.32"/>
                    <measurement group_id="O3" value="116.4" spread="9.62"/>
                    <measurement group_id="O4" value="106.3" spread="8.84"/>
                    <measurement group_id="O5" value="102.3" spread="9.81"/>
                    <measurement group_id="O6" value="101.9" spread="16.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diastolic Blood Pressure</title>
        <time_frame>At Baseline, 12 minutes, and 120 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)</title>
            <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
          </group>
          <group group_id="O3">
            <title>Cohort A: 12-17 High Dose (400uL Kovacaine Mist)</title>
            <description>400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
          <group group_id="O5">
            <title>Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)</title>
            <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
          </group>
          <group group_id="O6">
            <title>Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.6" spread="6.93"/>
                    <measurement group_id="O2" value="70.9" spread="7.16"/>
                    <measurement group_id="O3" value="62.1" spread="9.37"/>
                    <measurement group_id="O4" value="65.0" spread="11.71"/>
                    <measurement group_id="O5" value="63.8" spread="6.96"/>
                    <measurement group_id="O6" value="61.0" spread="8.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.9" spread="3.40"/>
                    <measurement group_id="O2" value="68.4" spread="7.85"/>
                    <measurement group_id="O3" value="66.1" spread="10.96"/>
                    <measurement group_id="O4" value="62.0" spread="6.78"/>
                    <measurement group_id="O5" value="64.6" spread="4.78"/>
                    <measurement group_id="O6" value="60.4" spread="7.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.3" spread="10.67"/>
                    <measurement group_id="O2" value="69.0" spread="10.57"/>
                    <measurement group_id="O3" value="70.1" spread="8.51"/>
                    <measurement group_id="O4" value="65.0" spread="6.41"/>
                    <measurement group_id="O5" value="61.6" spread="8.47"/>
                    <measurement group_id="O6" value="66.1" spread="13.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Heart Rate</title>
        <time_frame>At Baseline, 12 minutes, and 120 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)</title>
            <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
          </group>
          <group group_id="O3">
            <title>Cohort A: 12-17 High Dose (400uL Kovacaine Mist)</title>
            <description>400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
          <group group_id="O5">
            <title>Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)</title>
            <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
          </group>
          <group group_id="O6">
            <title>Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate</title>
          <units>bpm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.9" spread="10.55"/>
                    <measurement group_id="O2" value="83.6" spread="12.95"/>
                    <measurement group_id="O3" value="75.5" spread="14.80"/>
                    <measurement group_id="O4" value="90.3" spread="15.04"/>
                    <measurement group_id="O5" value="80.6" spread="7.41"/>
                    <measurement group_id="O6" value="90.1" spread="7.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.4" spread="10.06"/>
                    <measurement group_id="O2" value="80.9" spread="12.43"/>
                    <measurement group_id="O3" value="77.3" spread="18.52"/>
                    <measurement group_id="O4" value="91.6" spread="15.14"/>
                    <measurement group_id="O5" value="82.5" spread="9.01"/>
                    <measurement group_id="O6" value="89.3" spread="11.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.4" spread="11.02"/>
                    <measurement group_id="O2" value="84.3" spread="14.58"/>
                    <measurement group_id="O3" value="76.1" spread="10.45"/>
                    <measurement group_id="O4" value="91.9" spread="13.01"/>
                    <measurement group_id="O5" value="86.9" spread="7.10"/>
                    <measurement group_id="O6" value="95.0" spread="4.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oxygen Saturation</title>
        <time_frame>At Baseline, 12 minutes, and 120 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)</title>
            <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
          </group>
          <group group_id="O3">
            <title>Cohort A: 12-17 High Dose (400uL Kovacaine Mist)</title>
            <description>400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
          <group group_id="O5">
            <title>Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)</title>
            <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
          </group>
          <group group_id="O6">
            <title>Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)</title>
            <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
          </group>
        </group_list>
        <measure>
          <title>Oxygen Saturation</title>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" spread="1.28"/>
                    <measurement group_id="O2" value="98.8" spread="1.75"/>
                    <measurement group_id="O3" value="98.3" spread="1.39"/>
                    <measurement group_id="O4" value="97.3" spread="1.49"/>
                    <measurement group_id="O5" value="97.4" spread="2.00"/>
                    <measurement group_id="O6" value="97.6" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" spread="1.28"/>
                    <measurement group_id="O2" value="98.3" spread="1.49"/>
                    <measurement group_id="O3" value="97.9" spread="1.36"/>
                    <measurement group_id="O4" value="97.4" spread="1.30"/>
                    <measurement group_id="O5" value="96.3" spread="2.19"/>
                    <measurement group_id="O6" value="96.4" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.0" spread="0.93"/>
                    <measurement group_id="O2" value="97.4" spread="1.51"/>
                    <measurement group_id="O3" value="96.9" spread="1.64"/>
                    <measurement group_id="O4" value="96.0" spread="1.85"/>
                    <measurement group_id="O5" value="97.5" spread="1.31"/>
                    <measurement group_id="O6" value="97.5" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events by Dose Level and Age</title>
        <time_frame>from baseline to 24 hours following drug administration</time_frame>
        <population>Patients grouped by age</population>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist High Dose</title>
            <description>400uL of Kovacaine Mist, as 2 sprays of 200uL.&#xD;
400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each.</description>
          </group>
          <group group_id="O2">
            <title>Kovacaine Mist Mid Dose</title>
            <description>200uL of Kovacaine Mist, as 2 sprays of 100uL.&#xD;
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each.</description>
          </group>
          <group group_id="O3">
            <title>Kovacaine Mist Low Dose</title>
            <description>120uL of Kovacaine Mist, as 2 sprays of 60uL.&#xD;
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events by Dose Level and Age</title>
          <population>Patients grouped by age</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3-6 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7-11 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-17 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Adverse Events by Dose Level Regardless of Age</title>
        <time_frame>from baseline to 24 hours following drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist High Dose</title>
            <description>400uL of Kovacaine Mist, as 2 sprays of 200uL.&#xD;
400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each.</description>
          </group>
          <group group_id="O2">
            <title>Kovacaine Mist Mid Dose</title>
            <description>200uL of Kovacaine Mist, as 2 sprays of 100uL.&#xD;
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each.</description>
          </group>
          <group group_id="O3">
            <title>Kovacaine Mist Low Dose</title>
            <description>120uL of Kovacaine Mist, as 2 sprays of 60uL.&#xD;
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Adverse Events by Dose Level Regardless of Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 hours post-dosing</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)</title>
          <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
        </group>
        <group group_id="E2">
          <title>Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)</title>
          <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
        </group>
        <group group_id="E3">
          <title>Cohort A: 12-17 High Dose (400uL Kovacaine Mist)</title>
          <description>400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each</description>
        </group>
        <group group_id="E4">
          <title>Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)</title>
          <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
        </group>
        <group group_id="E5">
          <title>Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)</title>
          <description>200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each</description>
        </group>
        <group group_id="E6">
          <title>Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)</title>
          <description>120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Lacrimation Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Facial Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Sensory Disturbance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Nasal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Rhinalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pharyngeal Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Throat Irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Nasal Dryness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Intranasal Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Gregory D. Evans, DDS</name_or_title>
      <organization>Big Grins Pediatric Dentistry</organization>
      <phone>970-407-1020</phone>
      <email>greg@biggrinswithdrgreg.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01701505
org study id: SR 2-03
nct id: NCT01701505
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to assess the efficacy and safety of intranasally administered
      Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.
This is a single-center, open-label, randomized, parallel-groups, dose-ranging study to
      assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing
      maxillary teeth in pediatric subjects.

      The study will employ an open-label design to determine the lowest effective doses (LEDs),
      and assess the safety and efficacy of Kovacaine Mist administered intranasally for inducing
      pulpal anesthesia of maxillary primary teeth numbers A to J and maxillary permanent teeth
      numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar)
      sufficient to allow completion of the Study Dental Procedure, and will be carried out in
      healthy children of either sex between the ages of 3 and 17 years, inclusive.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.
time frame: at 14 minutes with a 3 minute window
description: If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.
measure: Naris Examination (NE) to Assess Reactions to the Study Drug.
time frame: At Baseline and 120 Minutes
description: The principal investigator will perform a visual inspection to note number of participants at post-dose that have a ulceration, inflammation or minor bleeding.
measure: Systolic Blood Pressure
time frame: At Baseline, 12 minutes, and 120 minutes
measure: Diastolic Blood Pressure
time frame: At Baseline, 12 minutes, and 120 minutes
measure: Heart Rate
time frame: At Baseline, 12 minutes, and 120 minutes
measure: Oxygen Saturation
time frame: At Baseline, 12 minutes, and 120 minutes
measure: Number of Participants With Adverse Events by Dose Level and Age
time frame: from baseline to 24 hours following drug administration
measure: Incidence of Adverse Events by Dose Level Regardless of Age
time frame: from baseline to 24 hours following drug administration
arm group label: Kovacaine Mist High Dose
arm group type: Experimental
description: 400uL of Kovacaine Mist, as 2 sprays of 200uL.
arm group label: Kovacaine Mist Mid Dose
arm group type: Experimental
description: 200uL of Kovacaine Mist, as 2 sprays of 100uL.
arm group label: Kovacaine Mist Low Dose
arm group type: Experimental
description: 120uL of Kovacaine Mist, as 2 sprays of 60uL.
intervention type: Drug
intervention name: 400uL of Kovacaine Mist
description: 2 unilateral intranasal sprays of 200uL each.
arm group label: Kovacaine Mist High Dose
other name: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
intervention type: Drug
intervention name: 200uL of Kovacaine Mist
description: 2 unilateral intranasal sprays of 100uL each.
arm group label: Kovacaine Mist Mid Dose
other name: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
intervention type: Drug
intervention name: 120uL of Kovacaine Mist
description: 2 unilateral intranasal sprays of 60uL each.
arm group label: Kovacaine Mist Low Dose
other name: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
criteria: 
gender: All
minimum age: 3 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Paul A. Moore, DMD/PhD/MPH
role: Study Director
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Sponsor
mesh term: Phenylephrine
mesh term: Oxymetazoline
mesh term: Tetracaine
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 