<?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>IRCT20180726040601N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-24</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the time of extubation, postoperative apnea incidence, and the quality of perioperative analgesia in infants scheduled for pyloromyotomy- Intravenous bolus fentanyl vs rectal acetaminophen</public_title>
      <acronym>HPS</acronym>
      <scientific_title>Comparing the time of extubation, postoperative apnea incidence, and the quality of perioperative analgesia in infants scheduled for pyloromyotomy-intravenous bolus fentanyl vs rectal acetaminophen</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33875</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using online program: URL:http://WWW.stat.vbc.ca/nrolin/statssize/bz.htmf, Blinding description: In this research patients and health care providers and analyzers were not aware of choosing people .</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertrophic Pyloric Stenosis.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Infants with Hypertrophic Pyloric Stenosis witch are candidate for surgery ; in this group we use Fentanyl as a pain relief . in Fentanyl group we will use Fentanyl (1μg/kg) with Midazolam .in both groups the time of discharge from recovery and the number of apneas that happened in recovery will be written . Intervention 2: Intervention group:  Infants with Hypertrophic Pyloric Stenosis witch are candidate for surgery ; in this group we use rectal Acetaminophen  as a pain relief. in acetaminophen group we will use rectal Acetaminophen ( 40mg/kg) before Midazolam .</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All the information will be shared after hidden the names

When:
It will be reachable after publish.

To whom:
All the information will be reachable for researchers .

Conditions:
No condition .

Where to obtain:
Children hospital of Tabriz.

How to obtain:
It will be reachable after publish

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behzad Aliakbar Sharabiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Children hospitalof Tabriz- Sheshgelan Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998134753</zip>
        <telephone>+98 21 2211 8956</telephone>
        <email>sahar.akbari292@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behzad Aliakbar Sharabiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Childrenhospital of Tabriz - Sheshgelan Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998134753</zip>
        <telephone>+98 21 2211 8956</telephone>
        <email>sharabiani48@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infants with Hypertrophic Pyloric Stenosis
Having no other problem</inclusion_criteria>
      <agemin>10 days</agemin>
      <agemax>2 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age more than 2 months
Weight less than 2.5 kg
Preterm labor
Serum Hg less than 10mg/dl
Serum bicarbonate more than 30mmol/l
Serum pH more than 55mmol/L
Using muscle relaxants</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P00-P96</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Digestive system disorders of fetus and newborn</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Infants with Hypertrophic Pyloric Stenosis witch are candidate for surgery ; in this group we use Fentanyl as a pain relief . in Fentanyl group we will use Fentanyl (1μg/kg) with Midazolam .in both groups the time of discharge from recovery and the number of apneas that happened in recovery will be written .</i_keyword>
      <i_keyword>Intervention group:  Infants with Hypertrophic Pyloric Stenosis witch are candidate for surgery ; in this group we use rectal Acetaminophen  as a pain relief. in acetaminophen group we will use rectal Acetaminophen ( 40mg/kg) before Midazolam .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowing that patients with  Hypertrophic Pyloric Stenosis are at risk of  long recovery and apnea after surgery، deleting drugs that cause this effect like Fentanyl and replacing it with Acetaminophen witch dose not have this effect will be useful .(in case of having same pain relief effect ) . in both groups the time of discharging from recovery and the number of apneas that happens in recovery after extubation will be recorded and the effects of this two drugs will be compared at the end . Timepoint: In Fentanyl group we use Fentanyl as a pain relief with Midazolam and in Acetaminophen group we use rectal Acetaminophen 20-30 min before Midazolam . Method of measurement: Recovery time with watch -Apnea with pulse oximetry.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-15</approval_date>
        <contact_name>Ethics committee of Tabriz university of medical sciences</contact_name>
        <contact_address>Children hospital of Tabriz - Sheshgelan Ave Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
