<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200707048047N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-01</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of lidocaine spray and vapocolant spray in reducing the pain of venous catheterization</public_title>
      <acronym></acronym>
      <scientific_title>A comparison between the effectiveness and safety of the combination of Licodain spray and vapocolant spray, and Licodain spray alone in local anesthesia during iv catheterization</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>116</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67813</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation method will be divided into 2 groups: 1- intervention with lidocaine spray along with Deltazax Powerice cooling spray and 2- intervention group with lidocaine spray alone. In order to randomly select 2 groups, dice will be used. Each of the samples will be placed in intervention group 1 if features 1, 2, 3 occur, and in intervention group 2 if features 4, 5, 6 occur. In the next step, the letter A (meaning intervention group 1) and letter B (meaning intervention group 2) will be placed in the envelope based on the choice made. For the first eligible person, envelope number one will be completed, and the envelopes will be given to the participants in order of number. and after opening the envelope, the type of individual group (intervention 1 and 2) was specified, Blinding description: Blinding is one-way blinding and the patient does not know the group she is in and the medicine used.</study_design>
      <phase>3</phase>
      <hc_freetext>Reduce the pain of  iv catheterization.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: intervention with lidocaine spray along with Deltazax Power Ice cooling spray, for this group, 10 puffs equivalent to 100 mg of 10% lidocaine solution (manufactured by Iran Daru Company) along with 10 puffs of Power Ice Deltazax cooling spray (manufactured by Delta Daru Company) for a period of It will be used for 5 minutes on the location of vein extraction in a circle with a diameter of 3 cm. After two to three minutes, the target area will be disinfected with cotton and alcohol to a diameter of 5 cm. After 60 seconds, the vein will be taken by professional nurses. It will be done.All cases of venipuncture are performed with angioket number 21 in the middle cubital vein area. Lidocaine spray is an effective painkiller in mucous membranes، Lidocaine topical solution spray is one of the common forms of lidocaine for clinical use. Lidocaine spray has a medium effect and is used for local anesthesia of mucous membranes and skin. Cooling spray is an aerosol spray containing a volatile gas that evaporates in contact with the skin, its cooling effect is used to relieve pain.10% lidocaine spray is used at the price of 473,000 rials per unit. Power Ice Deltasex cooling spray is used for five units at the price of 620,000 rials per unit. Intervention 2: Intervention group 2: The intervention group is with lidocaine spray alone, in this group, 10 puffs equivalent to 100 mg of 10% lidocaine solution (manufactured by Iran Daro Company) alone for 5 minutes on the venipuncture site in a circular manner with a diameter of 3 cm meter will be used. After two to three minutes, the desired area will be disinfected with cotton and alcohol to a diameter of 5 cm, and after 60 seconds, the vein will be taken by professional nurses. It is performed in the middle cubital vein area. Lidocaine spray is an effective pain reliever for mucous membranes،Lidocaine topical solution spray is one of the common forms of lidocaine for clinical use. Lidocaine spray has a medium effect and is used for local anesthesia of mucous membranes and skin.. Lidocaine spray 10% is used at the price of 473,000 rials per unit.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There are currently no plans to publish.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Moallm</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vahid dastgerdi</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1918613511</zip>
        <telephone>+98 21 2222 3567</telephone>
        <email>masoumehmoallem@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shima mosalanejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khage abdolah</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>16611645320</zip>
        <telephone>+98 21 2232 2780</telephone>
        <email>Shimaamosalanejad@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness and informed consent to participate in the study
Age above 18 years
Alert and able to communicate
No history of psychiatric disorders
Do not use any topical medication
Do not take painkillers for 12 hours before venipuncture
Willingness and informed consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of consent to enter the study
Addiction to opioids
Addiction to strong painkillers
History of allergy to any of the drugs used
Sensitivity to cold
A history of panic attacks
Patients with peripheral vascular diseases
Patients with sensory disorders such as peripheral neuropathy
Unwillingness to continue participating in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: intervention with lidocaine spray along with Deltazax Power Ice cooling spray, for this group, 10 puffs equivalent to 100 mg of 10% lidocaine solution (manufactured by Iran Daru Company) along with 10 puffs of Power Ice Deltazax cooling spray (manufactured by Delta Daru Company) for a period of It will be used for 5 minutes on the location of vein extraction in a circle with a diameter of 3 cm. After two to three minutes, the target area will be disinfected with cotton and alcohol to a diameter of 5 cm. After 60 seconds, the vein will be taken by professional nurses. It will be done.All cases of venipuncture are performed with angioket number 21 in the middle cubital vein area. Lidocaine spray is an effective painkiller in mucous membranes، Lidocaine topical solution spray is one of the common forms of lidocaine for clinical use. Lidocaine spray has a medium effect and is used for local anesthesia of mucous membranes and skin. Cooling spray is an aerosol spray containing a volatile gas that evaporates in contact with the skin, its cooling effect is used to relieve pain.10% lidocaine spray is used at the price of 473,000 rials per unit. Power Ice Deltasex cooling spray is used for five units at the price of 620,000 rials per unit.</i_keyword>
      <i_keyword>Intervention group 2: The intervention group is with lidocaine spray alone, in this group, 10 puffs equivalent to 100 mg of 10% lidocaine solution (manufactured by Iran Daro Company) alone for 5 minutes on the venipuncture site in a circular manner with a diameter of 3 cm meter will be used. After two to three minutes, the desired area will be disinfected with cotton and alcohol to a diameter of 5 cm, and after 60 seconds, the vein will be taken by professional nurses. It is performed in the middle cubital vein area. Lidocaine spray is an effective pain reliever for mucous membranes،Lidocaine topical solution spray is one of the common forms of lidocaine for clinical use. Lidocaine spray has a medium effect and is used for local anesthesia of mucous membranes and skin.. Lidocaine spray 10% is used at the price of 473,000 rials per unit.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity during venipuncture. Timepoint: Immediately after venipuncture. Method of measurement: visual analog scale (VAS), 0-3 is mild pain, 4-6 is moderate pain, and 7-10 is severe pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-06</approval_date>
        <contact_name>Ethics Committee of Azad University of Tehran Medical Sciences Branch</contact_name>
        <contact_address>Khaghani Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
