<?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>IRCT20221126056613N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-08</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Assessing the effect of adding magnesium sulfate to Boupivacain for caudal anesthesia on postoperative pain in  pediatric inguinal hernia repair surgery</public_title>
      <acronym></acronym>
      <scientific_title>Assessing the effect of adding magnesium sulfate to Boupivacain for caudal anesthesia on postoperative pain in  pediatric inguinal hernia repair surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67088</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be done by the random permutation block design method of two treatments with blocks of ten. First, 10 blocks of the composition (ABABABABAB) will be listed and a code will be assigned to each, then according to the sample size equal to 50, 5 blocks will be selected in this order that the letter A for The bupivacaine group and letter B will be considered for the bupivacaine + magnesium sulfate group.

Patients will be randomly assigned to two groups A and B using Random Allocation computer software. By selecting the simple randomization method in the randomization method section and entering the total sample size determined in this software, numbers will be given to the patients and the patients will be entered into two groups based on the numbers given by the computer.

Randomization will be done based on the permuted block randomization method. Each block will have 10 capacities. Based on the example of ABABABABAB, in each block, people are evenly assigned to two groups. 5 blocks will be built. After that, in each block, people are randomly assigned to bupivacaine group (A) (25 people) or bupivacaine + magnesium sulfate (B) group (25 people). In this study, randomization will be simple, in a box, numbers from 1 to 50 will be written on sheets of paper and placed inside the box in an unspecified manner. One sheet will be removed for each disease, if the number is even. It will be placed in the first group, and if it is an odd number, it will be in the second group, Blinding description: All the codes are secret and while the examiner will be one person and they will not be informed about the grouping of people, the method and process of conducting the study will be explained to the parents before prescribing the medicine.

The study will be double-blind, the parents of the patients and the clinical evaluator will be unaware of the placement of the patients in the study groups, in other words, both the parents will be unaware of the group they have been placed in, and the clinical evaluator will not know the group of the patients.

Finally, after collecting the data of each group separately, they will be compared by the clinical assessor - who does not know about the patient group.</study_design>
      <phase>1-2</phase>
      <hc_freetext>inguinal hernia.</hc_freetext>
      <i_freetext>Intervention 1: Children under caudal block, 5 cc of bupivacaine 0.5% will be added to 5 cc of normal saline or distilled water. Intervention 2: Intervention group: Bupivacaine + magnesium sulfate group - children are placed under caudal block and once 5cc of magnesium sulfate 20% will be added to 5cc of bupivacaine 0.5% from Shahid Ghazi Pharmaceutical Company.</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 According to the results of the study, I will decide to publish</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Akbar Nasir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam khomini university hospital-Eeshad AVE-Modarres Blvd-urmia-iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715781351</zip>
        <telephone>009844334557286</telephone>
        <email>Nasiriali7@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Akbar Nasir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam khomini university hospital-Eeshad AVE-Modarres Blvd-urmia-iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715781351</zip>
        <telephone>+98 44 3345 7286</telephone>
        <email>Nasiriali7@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children undergoing inguinal hernia repair surgery
American Society of Anesthesiologist (ASA) physical status
Children 2 months to 7 years
Absence of contraindications for pit blocks</inclusion_criteria>
      <agemin>2 months</agemin>
      <agemax>7 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Patients with mental disorders
patients with coagulation disorders
History of allergic reactions to local anesthetics
History of underlying diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K40.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bilateral inguinal hernia, with obstruction, without gangrene</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>Children under caudal block, 5 cc of bupivacaine 0.5% will be added to 5 cc of normal saline or distilled water.</i_keyword>
      <i_keyword>Intervention group: Bupivacaine + magnesium sulfate group - children are placed under caudal block and once 5cc of magnesium sulfate 20% will be added to 5cc of bupivacaine 0.5% from Shahid Ghazi Pharmaceutical Company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of pain. Timepoint: Times 1, 6, 12 and 24 hours after surgery. Method of measurement: Frankel pain measurement scale.</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>دانشگاه علوم پزشکی ارومیه</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-19</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>West Azarbaijan University of Medical Sciences, Resalat Blvd, Urmia Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
