<?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>IRCT20190810044500N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-22</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of nitroglycerine and lidocaine ointment on the pain caused by catheterization in neonates</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the effect of 2% nitroglycerin ointment - 2% lidocaine on the  pain control due to intravenous catheter in infants; randomized double-blind clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47524</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, 84 patients are randomly allocated into two treatment groups (A and B). Block randomization method will be used for random allocation. Fourteen blocks of six are considered. The generated permutations include the letters A and B, which are repeated thrice (for example, ABBABA) in each permutation. These permutations are generated using Random allocation software version 1. For this purpose, the generated list by the software is from 1 to 84, which are arranged in 14 blocks of six in order. To run this software output, we give the first qualified person number 1 and the last person will receive number 84. To consider blinding in random allocation, the list is given to another person outside the study and using short message service (SMS) before assigning the type of treatment according to the number of eligible people is asked and thus people enter the study. In addition, in the software output, both numbers 1 to 84 and the permutations of the letters A and B can be seen, Blinding description: The steps will be covered from the perspective of the patient, the treating physicianو, and the assessors. The first presenter identifies the sequence of assignments of patients according to the order of entry of the patients into the study, and puts the ointments (combination of nitroglycerin-lidocaine or placebo) into one-size boxes for patient use, and identifies them with A or B codes. The student then delivers the drugs to each individual patient.</study_design>
      <phase>3</phase>
      <hc_freetext>Measurement of pain during catheterization in infants.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Topical nitroglycerin ointment 2% - lidocaine 2%, one gram with an area of one square centimeter, on the infant venous site, apply and then wait for 10 minutes and then clean the site and venipuncture is performed and the amount Pain is measured. Intervention 2: Control group: Placebo ointment consisting of white wax and Vaseline made by Speedro company, 1gram with an area of one square centimeter, is applied on the infant venous site, and then wait for 10 minutes, after which the site is cleansed and venipuncture is performed and the pain is measured. Placebo ointment will be made in the Pharmaceutics Laboratory of Yazd School of Pharmacy.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Saghafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Professor Hesabi Boulevard, Yazd, Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173149</zip>
        <telephone>+98 35 3419 3820</telephone>
        <email>F.saghafi@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Saghafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Professor Hesabi Boulevard, Yazd, Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173149</zip>
        <telephone>+98 35 3419 3820</telephone>
        <email>F.saghafi@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infants with non-complicated cesarean delivery or normal birth
gestational age greater than 34 weeks and postnatal age less than 4 weeks
need to intravenous catheterization</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>1 month</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Parents' dissatisfaction with their baby's participation 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>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Topical nitroglycerin ointment 2% - lidocaine 2%, one gram with an area of one square centimeter, on the infant venous site, apply and then wait for 10 minutes and then clean the site and venipuncture is performed and the amount Pain is measured.</i_keyword>
      <i_keyword>Control group: Placebo ointment consisting of white wax and Vaseline made by Speedro company, 1gram with an area of one square centimeter, is applied on the infant venous site, and then wait for 10 minutes, after which the site is cleansed and venipuncture is performed and the pain is measured. Placebo ointment will be made in the Pharmaceutics Laboratory of Yazd School of Pharmacy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score of catheterization. Timepoint: After catheterization. Method of measurement: PIPP Score.</prim_outcome>
      <prim_outcome>How long the baby cries after catheterization. Timepoint: After catheterization. Method of measurement: The duration of the baby's crying is recorded in seconds.</prim_outcome>
      <prim_outcome>How long it takes for the baby to start crying. Timepoint: during catheterization. Method of measurement: The time it takes for a baby to start crying is recorded in seconds.</prim_outcome>
      <prim_outcome>How long the procedure lasts. Timepoint: during catheterization. Method of measurement: The duration of the procedure is recorded in seconds.</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>Family</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-12</approval_date>
        <contact_name>Ethics Committee of Medical School - Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Anonymous Martyrs Boulevard - Shahid Sadoughi University of Medical Sciences, Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
