<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/NCT02240628</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-14-0323</org_study_id>
    <nct_id>NCT02240628</nct_id>
  </id_info>
  <brief_title>Combining Placing a Synera Patch With Propofol/Lidocaine Mixture to Decrease Pain With IV Propofol Injection</brief_title>
  <official_title>In Children, Placing a Synera Patch for Intravenous Access Combined With Administration of a Propofol-Lidocaine Mixture Decreases Pain Associated With Propofol Intravenous Injection.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective is to evaluate if combining placing the Synera patch and using Propofol&#xD;
      /Lidocaine mixture will further decrease the pain associated with the IV injection of&#xD;
      Propofol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Commonly, anesthesiologists inject Propofol, a sleeping medication, intravenously to induce&#xD;
      general anesthesia.Propofol injection is commonly associated with burning pain. In a previous&#xD;
      onsite study we concluded that placing a Synera patch at least 30 minutes before placing the&#xD;
      IV decreased the pain associated with the Propofol injection. Also,a study documented that&#xD;
      adding Lidocaine to the Propofol decreases the pain associated with propofol injection. In&#xD;
      our study here we are trying to evaluate if combining the use of both the Synera patch and&#xD;
      the Propofol-Lidocaine mixture will further decrease the pain associated with the IV Propofol&#xD;
      injection.&#xD;
&#xD;
      All children will receive a Synera Patch, it will be placed on the dorsum of both hands for&#xD;
      at least 30 minutes.All Children will be Sedated with P.O Versed.&#xD;
&#xD;
      22 g IV will be started either in the holding area or in the OR. Children will be randomized&#xD;
      into groups using a computer generated randomization list:- Group 1 will receive Propofol&#xD;
      -Lidocaine mixture. Group 2 will receive Propofol-Saline mixture. An independent blinded&#xD;
      observer and an anesthesia member will independently evaluate pain on Propofol injection&#xD;
      according to pain scale.&#xD;
&#xD;
        1. No pain.&#xD;
&#xD;
        2. Mild Pain (associated with facial expression of pain).&#xD;
&#xD;
        3. Moderate Pain(Pulling the arm).&#xD;
&#xD;
        4. Severe Pain (screaming).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.</measure>
    <time_frame>During propofol injection.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>During Propofol injection.</time_frame>
    <description>A blinded independent observer will rate pain on Propofol injection according to a pain scale.&#xD;
No pain.&#xD;
Mild pain(associated with facial expression of pain).&#xD;
Moderate Pain(Pulling/withdrawal of arm).&#xD;
Severe Pain(Screaming).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Pain on IV Injection of Propofol.</condition>
  <arm_group>
    <arm_group_label>Propofol-Lidocaine mixture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol -Saline mixture</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lidocaine/tetracaine transdermal patch</intervention_name>
    <description>All patients in arm 1 and arm 2 will receive the Synera Patch.</description>
    <arm_group_label>Propofol -Saline mixture</arm_group_label>
    <arm_group_label>Propofol-Lidocaine mixture</arm_group_label>
    <other_name>NDC 43469-864-01</other_name>
    <other_name>Synera Patch</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Patients in arm 2 will receive Saline with the Propofol.</description>
    <arm_group_label>Propofol -Saline mixture</arm_group_label>
    <other_name>0.9% sodium chloride solution.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Patients in arm 1 will receive Lidocaine with the Propofol.</description>
    <arm_group_label>Propofol-Lidocaine mixture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Children 6-17 yrs.&#xD;
&#xD;
          -  Scheduled to receive general anesthesia for an elective procedure.&#xD;
&#xD;
          -  ASA classification 1-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with Skin disease and/or Skin infections.&#xD;
&#xD;
          -  Allergy to Propofol, Lidocaine or tetracaine.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>samia khalil, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Hermann Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <results_first_submitted>May 13, 2016</results_first_submitted>
  <results_first_submitted_qc>May 13, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 22, 2016</results_first_posted>
  <last_update_submitted>May 13, 2016</last_update_submitted>
  <last_update_submitted_qc>May 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Samia Khalil</investigator_full_name>
    <investigator_title>Professor Of Pediatric Anesthesia</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Tetracaine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Propofol-Lidocaine Mixture</title>
          <description>All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.&#xD;
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.&#xD;
Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol.</description>
        </group>
        <group group_id="P2">
          <title>Propofol -Saline Mixture</title>
          <description>All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.&#xD;
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.&#xD;
Saline: Patients in arm 2 will receive Saline with the Propofol.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Propofol-Lidocaine Mixture</title>
          <description>All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.&#xD;
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.&#xD;
Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol.</description>
        </group>
        <group group_id="B2">
          <title>Propofol -Saline Mixture</title>
          <description>All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.&#xD;
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.&#xD;
Saline: Patients in arm 2 will receive Saline with the Propofol.</description>
        </group>
        <group group_id="B3">
          <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="32"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="65"/>
          </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="14.3750" spread="2.2683"/>
                    <measurement group_id="B2" value="14.5455" spread="2.0930"/>
                    <measurement group_id="B3" value="14.46025" spread="2.18065"/>
                  </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="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.</title>
        <time_frame>During propofol injection.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol-Lidocaine Mixture</title>
            <description>All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.&#xD;
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.&#xD;
Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol.</description>
          </group>
          <group group_id="O2">
            <title>Propofol -Saline Mixture</title>
            <description>All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.&#xD;
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.&#xD;
Saline: Patients in arm 2 will receive Saline with the Propofol.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Intensity</title>
        <description>A blinded independent observer will rate pain on Propofol injection according to a pain scale.&#xD;
No pain.&#xD;
Mild pain(associated with facial expression of pain).&#xD;
Moderate Pain(Pulling/withdrawal of arm).&#xD;
Severe Pain(Screaming).</description>
        <time_frame>During Propofol injection.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol-Lidocaine Mixture</title>
            <description>All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.&#xD;
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.&#xD;
Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol.</description>
          </group>
          <group group_id="O2">
            <title>Propofol -Saline Mixture</title>
            <description>All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.&#xD;
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.&#xD;
Saline: Patients in arm 2 will receive Saline with the Propofol.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Intensity</title>
          <description>A blinded independent observer will rate pain on Propofol injection according to a pain scale.&#xD;
No pain.&#xD;
Mild pain(associated with facial expression of pain).&#xD;
Moderate Pain(Pulling/withdrawal of arm).&#xD;
Severe Pain(Screaming).</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Propofol-Lidocaine Mixture</title>
          <description>All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.&#xD;
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.&#xD;
Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol.</description>
        </group>
        <group group_id="E2">
          <title>Propofol -Saline Mixture</title>
          <description>All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.&#xD;
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.&#xD;
Saline: Patients in arm 2 will receive Saline with the Propofol.</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="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0.5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <description>Erythema at site of the Synera patch was noted after removal of the patch which resolved by itself.</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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. Samia Khalil</name_or_title>
      <organization>The University of Texas Health Science Center at Houston</organization>
      <phone>713-500-6242</phone>
      <email>Samia.N.Khalil@uth.tmc.edu</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/NCT02240628
org study id: HSC-MS-14-0323
nct id: NCT02240628
lead sponsor: 
has dmc: No
The main objective is to evaluate if combining placing the Synera patch and using Propofol
      /Lidocaine mixture will further decrease the pain associated with the IV injection of
      Propofol.
Commonly, anesthesiologists inject Propofol, a sleeping medication, intravenously to induce
      general anesthesia.Propofol injection is commonly associated with burning pain. In a previous
      onsite study we concluded that placing a Synera patch at least 30 minutes before placing the
      IV decreased the pain associated with the Propofol injection. Also,a study documented that
      adding Lidocaine to the Propofol decreases the pain associated with propofol injection. In
      our study here we are trying to evaluate if combining the use of both the Synera patch and
      the Propofol-Lidocaine mixture will further decrease the pain associated with the IV Propofol
      injection.

      All children will receive a Synera Patch, it will be placed on the dorsum of both hands for
      at least 30 minutes.All Children will be Sedated with P.O Versed.

      22 g IV will be started either in the holding area or in the OR. Children will be randomized
      into groups using a computer generated randomization list:- Group 1 will receive Propofol
      -Lidocaine mixture. Group 2 will receive Propofol-Saline mixture. An independent blinded
      observer and an anesthesia member will independently evaluate pain on Propofol injection
      according to pain scale.

        1. No pain.

        2. Mild Pain (associated with facial expression of pain).

        3. Moderate Pain(Pulling the arm).

        4. Severe Pain (screaming).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.
time frame: During propofol injection.
measure: Pain Intensity
time frame: During Propofol injection.
description: A blinded independent observer will rate pain on Propofol injection according to a pain scale.
No pain.
Mild pain(associated with facial expression of pain).
Moderate Pain(Pulling/withdrawal of arm).
Severe Pain(Screaming).
arm group label: Propofol-Lidocaine mixture
arm group type: Active Comparator
description: All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.
arm group label: Propofol -Saline mixture
arm group type: Placebo Comparator
description: All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.
intervention type: Device
intervention name: Lidocaine/tetracaine transdermal patch
description: All patients in arm 1 and arm 2 will receive the Synera Patch.
arm group label: Propofol -Saline mixture
arm group label: Propofol-Lidocaine mixture
other name: NDC 43469-864-01
other name: Synera Patch
intervention type: Drug
intervention name: Saline
description: Patients in arm 2 will receive Saline with the Propofol.
arm group label: Propofol -Saline mixture
other name: 0.9% sodium chloride solution.
intervention type: Drug
intervention name: Lidocaine
description: Patients in arm 1 will receive Lidocaine with the Propofol.
arm group label: Propofol-Lidocaine mixture
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: samia khalil, M.D
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Samia Khalil
investigator title: Professor Of Pediatric Anesthesia
mesh term: Lidocaine
mesh term: Tetracaine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 