<?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>IRCT20200707048047N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-07</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the effect of local anesthesia induced by intradermal injection of ketamine with lidocaine in intravenous venipuncture</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of local anesthesia induced by intradermal injection of ketamine with lidocaine in intravenous venipuncture</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>246</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64457</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Blinding is done in such a way that ketamine, lidocaine and normal saline are poured into similar 100 ml vials and each of the letters a, b, c is written and patients are randomly divided into three groups. Depending on whether they were in groups 1,2 or 3, they will receive a coded vial, and the researcher prescribing the drug is not aware of the type of drug, and later in the statistical analysis it will be determined which drug in each group Patients Nurses and data collectors do not know the type of substance used for each patient.</study_design>
      <phase>3</phase>
      <hc_freetext>venipuncture.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention procedure: 0.2 ml of buffered lidocaine, which is obtained by adding two ml of 7.5% bicarbonate to twenty-two ml of 1% lidocaine, is injected intradermally. The second intervention group: 0.2 ml of 1 mg ketamine solution will be injected intradermally. After two to three minutes, the target area will be disinfected and the vein will be removed by professional nurses who did not know about the study. All cases of venipuncture are performed using venous catheter gage 21 in the area of ​​the middle cubital vein.Ketamine is a cyclohexanone derivative used to induce anesthesia. Its mechanism of action is not well understood, but ketamine can block NMDA (N-Methyl-D-Aspartate) receptors and may interact with sigma receptors. Lidocaine is a local anesthetic and cardiac depressant that is known as Antiarrhythmic agent is used. Its action is more intense and its effects are longer than the effects of procaine, but its duration of action is shorter than that of bupivacaine or prilocaine.Three vials of lidocaine 2% (50 ml) are used at the unit price of 1471000 Rial in Shahid Ghazi pharmaceutical company, built inside. Ketamine vials of 50 mg/ml (10 ml) are three units at the unit price of 3500000 in the pharmaceutical company. Internally made elixir is used. 246 pink venous catheter are used at the unit price of 33,000 Rial made by Polymed. 246 sets of serums are used at a unit price of 55,000 Rial made by Polymed. Intervention 2: Control group: Control group: 0.2 ml of normal saline will be injected intradermally and after two to three minutes the target area will be disinfected and the vein will be removed by professional nurses who were not aware of the study. All cases of venipuncture are performed using venous catheter gage 21 in the area of ​​the middle cubital vein. Injectable normal saline is used in four units at the price of 184,800 Rial, the Iranian injectable and medicinal products.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is PATIENTS PRIVACY</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>masoumeh moallem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>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>Shimaa Mosalanejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khaje abdollah</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1661645320</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>عدم تمایل بیمار به ادامه مشارکت در مطالعه
سابقه حساسیت به بی حس کننده های موضعی ( لیدوکائین/پریلوکائین تتراکائین و بنزوکائین)
اعتیاد به اپیوئیدها
اعتیاد به ضد دردهای قوی
مناسب نبودن عروق ناحیه آنته کوبیتال جهت رگ گیری
بیماری های عروق محیطی
اختلالات حسی مثل نوروپاتی دیابتی
اختلالات شناختی
سابقه فوبیا سوزن و حملات پانیک</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>The first intervention procedure: 0.2 ml of buffered lidocaine, which is obtained by adding two ml of 7.5% bicarbonate to twenty-two ml of 1% lidocaine, is injected intradermally. The second intervention group: 0.2 ml of 1 mg ketamine solution will be injected intradermally. After two to three minutes, the target area will be disinfected and the vein will be removed by professional nurses who did not know about the study. All cases of venipuncture are performed using venous catheter gage 21 in the area of ​​the middle cubital vein.Ketamine is a cyclohexanone derivative used to induce anesthesia. Its mechanism of action is not well understood, but ketamine can block NMDA (N-Methyl-D-Aspartate) receptors and may interact with sigma receptors. Lidocaine is a local anesthetic and cardiac depressant that is known as Antiarrhythmic agent is used. Its action is more intense and its effects are longer than the effects of procaine, but its duration of action is shorter than that of bupivacaine or prilocaine.Three vials of lidocaine 2% (50 ml) are used at the unit price of 1471000 Rial in Shahid Ghazi pharmaceutical company, built inside. Ketamine vials of 50 mg/ml (10 ml) are three units at the unit price of 3500000 in the pharmaceutical company. Internally made elixir is used. 246 pink venous catheter are used at the unit price of 33,000 Rial made by Polymed. 246 sets of serums are used at a unit price of 55,000 Rial made by Polymed.</i_keyword>
      <i_keyword>Control group: Control group: 0.2 ml of normal saline will be injected intradermally and after two to three minutes the target area will be disinfected and the vein will be removed by professional nurses who were not aware of the study. All cases of venipuncture are performed using venous catheter gage 21 in the area of ​​the middle cubital vein. Injectable normal saline is used in four units at the price of 184,800 Rial, the Iranian injectable and medicinal products.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of pain caused by venipuncture. Timepoint: Three minutes after the intervention. Method of measurement: Visual analog scale (VAS). (0-3) mild pain, (4-6) moderate pain and (10-7) 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>2022-03-12</approval_date>
        <contact_name>کمیته‌ اخلاق در پژوهش دانشکده پزشکی- دانشگاه علوم پزشکی آزاد اسلامی تهران</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>
