<?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>IRCT20170516033992N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-06</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the postoperative analgesia between the caudal and ilioinguinal/ iliohypogastric blocks</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the postoperative analgesia between the caudal and ilioinguinal/ iliohypogastric blocks in pediatric inguinal hernia repair surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64587</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Patients will be divided into two groups using block randomization based on generated numbers by Random allocation software. Thus, in this software, first, the number of groups and the total number of the sample size will be entered, and then in the block section, the Block randomization method will be selected. Patients will be allocated to one of two block methods based on generated numbers, Blinding description: The study will be conducted as a double-blind clinical trial. The patient and the researcher who will be evaluating the outcomes will be blind to the allocation of patients into two blocks. Blocks will be performed by an anesthesiologist (other than the outcome assessor) and the name of blocks will be encoded with the letters A and B.</study_design>
      <phase>3</phase>
      <hc_freetext>Postoperative pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: group 1: Patients will be under general anesthesia with midazolam 0.05 mg/kg, fentanyl 1 microgram/kg, lidocaine 1 mg/kg, and propofol 3 mg/kg. Then, the caudal block will be performed using a 22-gauge needle from the sacral hiatus space with 1 ml/kg bupivacaine 0.2% and epinephrine 5 micrograms/kg at the lateral decubitus position before surgery. Intervention 2: Intervention group: group 2: Patients will be under general anesthesia with midazolam 0.05 mg/kg, fentanyl 1 microgram/kg, lidocaine 1 mg/kg, and propofol 3 mg/kg. Then, an ilioinguinal/iliohypogastric block will be performed with 0.1 cc/kg of bupivacaine 0.2% and epinephrine 5 micrograms/kg before surgery.</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 Confidentiality of patient information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Tohid Karami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Motahhari hospital., Kashani Ave, Urmia, Iran.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3223 7077</telephone>
        <email>karami.t@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Tohid Karami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Motahhari hospital., Kashani Ave., Urmia., Iran.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3223 7077</telephone>
        <email>karami.t@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with physical status equal to or greater than two according to the criteria of the American Anesthesia Association (II&gt;ASA)
Aged between 6 months and 5 years
Not having a spinal deformity</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>5 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Coagulation problems such as hemophilia, DIC
Severe infections such as septicemia, meningitis
Brain tumors with increased intracranial pressure
Allergy to local anesthetics
Chemotherapy with drugs such as cisplatin
Hypovolemia
Skin or subcutaneous lesions like infection, angioma at the puncture site</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>MG31.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute postoperative pain, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: group 1: Patients will be under general anesthesia with midazolam 0.05 mg/kg, fentanyl 1 microgram/kg, lidocaine 1 mg/kg, and propofol 3 mg/kg. Then, the caudal block will be performed using a 22-gauge needle from the sacral hiatus space with 1 ml/kg bupivacaine 0.2% and epinephrine 5 micrograms/kg at the lateral decubitus position before surgery.</i_keyword>
      <i_keyword>Intervention group: group 2: Patients will be under general anesthesia with midazolam 0.05 mg/kg, fentanyl 1 microgram/kg, lidocaine 1 mg/kg, and propofol 3 mg/kg. Then, an ilioinguinal/iliohypogastric block will be performed with 0.1 cc/kg of bupivacaine 0.2% and epinephrine 5 micrograms/kg before surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score. Timepoint: in recovery, 6, 12 and 24 hours after surgery. Method of measurement: Face, Legs, Activity, Cry, Consolability (FLACC)  pain scale.</prim_outcome>
      <prim_outcome>Prescribing an analgesic. Timepoint: after surgery. Method of measurement: yes/no.</prim_outcome>
      <prim_outcome>The time of the first request for an analgesic. Timepoint: after surgery. Method of measurement: Minute.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hart rate. Timepoint: In recovery, 6, 12 and 24 hours after surgery. Method of measurement: Monitoring.</sec_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: In recovery, 6, 12 and 24 hours after surgery. Method of measurement: Monitoring.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: In recovery, 6, 12 and 24 hours after surgery. Method of measurement: Monitoring.</sec_outcome>
      <sec_outcome>Nausea and vomiting. Timepoint: After surgery. Method of measurement: yes/no.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-25</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran. Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
