<?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>IRCT20120911010811N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-13</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of pediatric intravenous acetaminophen and acetaminophen suppository in hernia surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of caudal block, intravenous and suppository acetaminophen preemptive analgesia in pediatric inguinal herniotomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>159</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60978</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups, Blinding description: In this study, participants are not aware of the intervention and the type of treatment received . Also, outcome assessors are unaware of how patients are grouped.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Patients with inguinal hernia who are candidates for surgery.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Children who are candidates for inguinal hernia repair surgery, general anesthesia is performed with 1 mg / kg fentanyl, 3 to 5 mg / kg 1% propofol and 0.5 mg / kg atracurium, the patient is intubated After induction and before surgery, they are placed in a caudal block with 0.25% bupivacaine at a dose of 1 ml / kg. At the end of surgery and extubation, the patient is transferred to recovery and  the patient's pain is measured according to the behaivorial-FLACC criterion. Intervention 2: Intervention group: Children who are candidates for inguinal hernia repair surgery: General anesthesia is performed with 1 mg / kg fentanyl, 3 to 5 mg / kg 1% propofol, and 0.5 mg / kg atracurium. The patient is intubated, after induction and before surgery, intravenous acetaminophen is prescribed at 12.5 mg / kg, after the end of surgery and extubation,  transferred to recovery and the patient's pain is measured according to the behaivorial-FLACC criterion. Intervention 3: Intervention group: Children who are candidates for inguinal hernia repair surgery: General anesthesia is performed with 1 mg / kg fentanyl, 3 to 5 mg / kg 1% propofol, and 0.5 mg / kg atracurium. The patient is intubated, after induction and before surgery,  acetaminophen suppositories are given at a dose of 15 mg / kg, after the end of surgery and extubation, transferred to recovery and the patient's pain is measured according to the behaivorial-FLACC criterion.</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 Relevant partners should be consulted to publish the data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Sabzevari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Akbar Hospital, television Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9176999311</zip>
        <telephone>+98 51 3871 3803</telephone>
        <email>sabzevaria@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Sabzevari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Akbar Hospital, television Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9176999311</zip>
        <telephone>+98 51 3871 3803</telephone>
        <email>sabzevaria@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Candidate for inguinal hernia repair surgery
Parents' consent based on children's participation in the study
Participants are children from 6 months to 3 years</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>3 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of bupivacaine allergy
Existence of local infection in the spine
Presence of pilonidal cyst
History of acetaminophen allergy
History of liver problems
History of heart disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Inguinal hernia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Children who are candidates for inguinal hernia repair surgery, general anesthesia is performed with 1 mg / kg fentanyl, 3 to 5 mg / kg 1% propofol and 0.5 mg / kg atracurium, the patient is intubated After induction and before surgery, they are placed in a caudal block with 0.25% bupivacaine at a dose of 1 ml / kg. At the end of surgery and extubation, the patient is transferred to recovery and  the patient's pain is measured according to the behaivorial-FLACC criterion.</i_keyword>
      <i_keyword>Intervention group: Children who are candidates for inguinal hernia repair surgery: General anesthesia is performed with 1 mg / kg fentanyl, 3 to 5 mg / kg 1% propofol, and 0.5 mg / kg atracurium. The patient is intubated, after induction and before surgery, intravenous acetaminophen is prescribed at 12.5 mg / kg, after the end of surgery and extubation,  transferred to recovery and the patient's pain is measured according to the behaivorial-FLACC criterion.</i_keyword>
      <i_keyword>Intervention group: Children who are candidates for inguinal hernia repair surgery: General anesthesia is performed with 1 mg / kg fentanyl, 3 to 5 mg / kg 1% propofol, and 0.5 mg / kg atracurium. The patient is intubated, after induction and before surgery,  acetaminophen suppositories are given at a dose of 15 mg / kg, after the end of surgery and extubation, transferred to recovery and the patient's pain is measured according to the behaivorial-FLACC criterion.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of analgesia. Timepoint: After inguinal hernia surgery in recovery. Method of measurement: Based on the behaivorial-FLACC criteria.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-30</approval_date>
        <contact_name>Ethic committe of Mashhad university of Medical Sciences</contact_name>
        <contact_address>Ghoreyshi Building, Daneshgah street, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
