<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/NCT04473820</url>
  </required_header>
  <id_info>
    <org_study_id>9111215292</org_study_id>
    <nct_id>NCT04473820</nct_id>
  </id_info>
  <brief_title>Comparison of Lidocaine-Prilocaine Combination and Vapocoolant for IV Cannulation Pain in the ED</brief_title>
  <official_title>Comparison of The Efficacy of Lidocaine-Prilocaine Combination and Vapocoolant Spray to Reduce Pain of IV Cannulation in The Emergency Department: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tehran University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tehran University of Medical Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis: Lidocaine-Prilocaine Combination is as effective as Vapocoolant in treating IV&#xD;
      cannulation pain in the emergency department.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lidocain-Prilocaine combination cream is two amide-type local anesthetics used for topical&#xD;
      skin anesthesia. Vapocoolant spray is also another method for providing appropriate analgesia&#xD;
      through crayoanesthetic mechanisms. Although there are some contraindications and adverse&#xD;
      effects, these are widely used in the Emergency Department (ED) for IV cannulation pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 10, 2020</start_date>
  <completion_date type="Anticipated">February 20, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 10, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cannulation pain: numerical rating score (NRS)</measure>
    <time_frame>immediately after the procedure.</time_frame>
    <description>The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Application pain: numerical rating score (NRS)</measure>
    <time_frame>immediately after the procedure.</time_frame>
    <description>The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catheterization attempts</measure>
    <time_frame>immediately after the procedure.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Vapocoolant spray</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lidocaine-Prilocaine cream</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vapocoolant spray</intervention_name>
    <description>The spray will be applied continuously from 25 cm distance for less than 5 seconds to the cannulation site.</description>
    <arm_group_label>Vapocoolant spray</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine-Prilocaine cream</intervention_name>
    <description>A finger tip (0.5 gr) of the cream will be applied in 4 square cm at cannulation site and will be covered with closed dressing for 45 minutes.</description>
    <arm_group_label>Lidocaine-Prilocaine cream</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Low acute patients who are waiting for the admission to the ED and require IV&#xD;
             cannulation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Altered mental status&#xD;
&#xD;
          -  Uncooperative patients&#xD;
&#xD;
          -  Unable to communicate&#xD;
&#xD;
          -  Known history of hypersensitivity reaction to cold or amid analgesics&#xD;
&#xD;
          -  Analgesic usage in previous 6 hours&#xD;
&#xD;
          -  No consent&#xD;
&#xD;
          -  Emergent condition&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hadi Mirfazaelian, M.D.</last_name>
    <phone>00982166904848</phone>
    <email>h-mirfazaelian@sina.tums.ac.ir</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Atousa Akhgar, M.D.</last_name>
    <phone>00982166904848</phone>
    <email>at.akhgar@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>IKCH</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tehran University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Hadi Mirfazaelian</investigator_full_name>
    <investigator_title>Assistant Professor of Emergency Medicine</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Prilocaine</mesh_term>
    <mesh_term>Lidocaine, Prilocaine Drug Combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04473820
org study id: 9111215292
nct id: NCT04473820
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Hypothesis: Lidocaine-Prilocaine Combination is as effective as Vapocoolant in treating IV
      cannulation pain in the emergency department.
Lidocain-Prilocaine combination cream is two amide-type local anesthetics used for topical
      skin anesthesia. Vapocoolant spray is also another method for providing appropriate analgesia
      through crayoanesthetic mechanisms. Although there are some contraindications and adverse
      effects, these are widely used in the Emergency Department (ED) for IV cannulation pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Cannulation pain: numerical rating score (NRS)
time frame: immediately after the procedure.
description: The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity.
measure: Application pain: numerical rating score (NRS)
time frame: immediately after the procedure.
description: The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity.
measure: Catheterization attempts
time frame: immediately after the procedure.
arm group label: Vapocoolant spray
arm group type: Active Comparator
arm group label: Lidocaine-Prilocaine cream
arm group type: Active Comparator
intervention type: Drug
intervention name: Vapocoolant spray
description: The spray will be applied continuously from 25 cm distance for less than 5 seconds to the cannulation site.
arm group label: Vapocoolant spray
intervention type: Drug
intervention name: Lidocaine-Prilocaine cream
description: A finger tip (0.5 gr) of the cream will be applied in 4 square cm at cannulation site and will be covered with closed dressing for 45 minutes.
arm group label: Lidocaine-Prilocaine cream
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hadi Mirfazaelian, M.D.
phone: 00982166904848
email: h-mirfazaelian@sina.tums.ac.ir
last name: Atousa Akhgar, M.D.
phone: 00982166904848
email: at.akhgar@gmail.com
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Tehran University of Medical Sciences
investigator full name: Hadi Mirfazaelian
investigator title: Assistant Professor of Emergency Medicine
mesh term: Lidocaine
mesh term: Prilocaine
mesh term: Lidocaine, Prilocaine Drug Combination
sharing ipd: No