<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/NCT01690767</url>
  </required_header>
  <id_info>
    <org_study_id>17770</org_study_id>
    <nct_id>NCT01690767</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Ability of 2% Lidocaine Gel to Reduce the Discomfort of Urethral Catheterization</brief_title>
  <official_title>A Randomized Blinded Controlled Trial of 2% Lidocaine Gel Compared to Standard of Care in Children Undergoing Urethral Catheterization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children 0-24 months of age requiring a urethral catheterization for urine collection will be&#xD;
      randomized to receive either topical and intraurethral 2% lidocaine or standard of care to&#xD;
      assess for the effectiveness of the former in minimizing pain during urethral&#xD;
      catheterization. It is hypothesized that administration of 2% lidocaine gel both topically&#xD;
      and intraurethrally will confer a greater degree of pain reduction compared to standard of&#xD;
      care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An estimated 10% of children 0-24 months of age that present to the emergency department (ED)&#xD;
      with fever and/or vomiting have a urinary tract infection (UTI). An accurate diagnosis of a&#xD;
      UTI ensures timely and appropriate treatment given to reduce the risk of renal scarring,&#xD;
      which is the greatest in this age group. To ensure diagnostic accuracy, urethral&#xD;
      catheterization is the preferred method to obtain a urine sample from a young child. In&#xD;
      contrast to adults, most children do not receive local analgesia for urethral&#xD;
      catheterization; despite growing recognition that children experience avoidable pain and&#xD;
      discomfort during invasive procedures.&#xD;
&#xD;
      Following informed consent, participants will be randomized by block randomization in a&#xD;
      concealed fashion to receive either topical and intraurethral 2% lidocaine or standard of&#xD;
      care using a computerized random number generator. The research nurse will access a&#xD;
      sequentially numbered, opaque sealed envelope that will contain the participant's group&#xD;
      assignment. No adjunctive analgesic methods will be used. A research pharmacist will prepare&#xD;
      2% lidocaine gel in a 3 cc syringe attached to a 24 gauge angiocath. Children &lt; 7 kg and &gt; 7&#xD;
      kg will receive 1 cc and 1.5 cc, respectively (2).&#xD;
&#xD;
      The entire procedure will be videotaped and participants pain will be scored using a brow&#xD;
      bulging score and visual analogue scale by independent, blinded raters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brow Bulging Score</measure>
    <time_frame>30 seconds post intervention compared to baseline</time_frame>
    <description>The presence of brow bulging will be scored in 2-second intervals for the first 30 seconds for each of the six phases. The percentage of time that brow bulging is observed will then be calculated for each phase.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Facial grimacing score</measure>
    <time_frame>30 seconds post intervention compared to placebo</time_frame>
    <description>The presence of brow bulging, nasolabial furrowing and eyes squeezing shut will be scored in 2-second intervals for the first 30 seconds for each of the six phases. The percentage of time that all three of these features is observed will then be calculated for each phase.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Urinary Tract Infection</condition>
  <arm_group>
    <arm_group_label>Topical and intraurethral 2% lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2% lidocaine gel will be applied for 5 minutes to the external urethral opening. This will be followed immediately by 2% lidocaine gel administration into the urethra using a 24 gauge angiocath for 5 minutes prior to catheterization for urine specimen collection. Children &lt; 7 kg and &gt; 7 kg will receive 1 cc and 1.5 cc, respectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>According to standard nursing practice, the urethra will be catheterized without anaesthetic gel but using lubricant gel only. Intervention is Health Care Lubricating Jelly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2% lidocaine gel</intervention_name>
    <description>Children &lt; 7 kg and &gt; 7 kg will receive 1 cc and 1.5 cc of 2% lidocaine gel, respectively</description>
    <arm_group_label>Topical and intraurethral 2% lidocaine</arm_group_label>
    <other_name>Lidocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Health Care Lubricating Jelly</intervention_name>
    <description>Non-medicinal lubrication gel</description>
    <arm_group_label>Standard of care</arm_group_label>
    <other_name>Muco</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children 0-24 months of age presenting to the emergency department requiring a&#xD;
             urethral catheterization to obtain a urine specimen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unstable&#xD;
&#xD;
          -  external genitourinary anomalies&#xD;
&#xD;
          -  lidocaine allergy and&#xD;
&#xD;
          -  previous catheterization within 24 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naveen Poonai, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital, London Health Sciences Center</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6C 2V5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>February 15, 2011</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>March 25, 2015</last_update_submitted>
  <last_update_submitted_qc>March 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Naveen Poonai</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <keyword>Urethral catheterization</keyword>
  <keyword>Lidocaine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Tract Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01690767
org study id: 17770
nct id: NCT01690767
lead sponsor: 
has dmc: No
Children 0-24 months of age requiring a urethral catheterization for urine collection will be
      randomized to receive either topical and intraurethral 2% lidocaine or standard of care to
      assess for the effectiveness of the former in minimizing pain during urethral
      catheterization. It is hypothesized that administration of 2% lidocaine gel both topically
      and intraurethrally will confer a greater degree of pain reduction compared to standard of
      care.
An estimated 10% of children 0-24 months of age that present to the emergency department (ED)
      with fever and/or vomiting have a urinary tract infection (UTI). An accurate diagnosis of a
      UTI ensures timely and appropriate treatment given to reduce the risk of renal scarring,
      which is the greatest in this age group. To ensure diagnostic accuracy, urethral
      catheterization is the preferred method to obtain a urine sample from a young child. In
      contrast to adults, most children do not receive local analgesia for urethral
      catheterization; despite growing recognition that children experience avoidable pain and
      discomfort during invasive procedures.

      Following informed consent, participants will be randomized by block randomization in a
      concealed fashion to receive either topical and intraurethral 2% lidocaine or standard of
      care using a computerized random number generator. The research nurse will access a
      sequentially numbered, opaque sealed envelope that will contain the participant's group
      assignment. No adjunctive analgesic methods will be used. A research pharmacist will prepare
      2% lidocaine gel in a 3 cc syringe attached to a 24 gauge angiocath. Children < 7 kg and > 7
      kg will receive 1 cc and 1.5 cc, respectively (2).

      The entire procedure will be videotaped and participants pain will be scored using a brow
      bulging score and visual analogue scale by independent, blinded raters.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Brow Bulging Score
time frame: 30 seconds post intervention compared to baseline
description: The presence of brow bulging will be scored in 2-second intervals for the first 30 seconds for each of the six phases. The percentage of time that brow bulging is observed will then be calculated for each phase.
measure: Facial grimacing score
time frame: 30 seconds post intervention compared to placebo
description: The presence of brow bulging, nasolabial furrowing and eyes squeezing shut will be scored in 2-second intervals for the first 30 seconds for each of the six phases. The percentage of time that all three of these features is observed will then be calculated for each phase.
arm group label: Topical and intraurethral 2% lidocaine
arm group type: Experimental
description: 2% lidocaine gel will be applied for 5 minutes to the external urethral opening. This will be followed immediately by 2% lidocaine gel administration into the urethra using a 24 gauge angiocath for 5 minutes prior to catheterization for urine specimen collection. Children < 7 kg and > 7 kg will receive 1 cc and 1.5 cc, respectively.
arm group label: Standard of care
arm group type: Active Comparator
description: According to standard nursing practice, the urethra will be catheterized without anaesthetic gel but using lubricant gel only. Intervention is Health Care Lubricating Jelly.
intervention type: Drug
intervention name: 2% lidocaine gel
description: Children < 7 kg and > 7 kg will receive 1 cc and 1.5 cc of 2% lidocaine gel, respectively
arm group label: Topical and intraurethral 2% lidocaine
other name: Lidocaine
intervention type: Drug
intervention name: Health Care Lubricating Jelly
description: Non-medicinal lubrication gel
arm group label: Standard of care
other name: Muco
criteria: 
gender: All
minimum age: N/A
maximum age: 24 Months
healthy volunteers: No
last name: Naveen Poonai, MD, FRCPC
role: Principal Investigator
affiliation: Western University, Canada
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Naveen Poonai
investigator title: Attending Physician
mesh term: Urinary Tract Infections
mesh term: Lidocaine