<?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>IRCT20190325043107N20</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-31</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>ketorolac + low dose pethidine comparison with pethidine after elective laparotomy leading to colectomy</public_title>
      <acronym></acronym>
      <scientific_title>Assessing analgesia in mixed administrations of ketorolac + low dose pethidine comparison with pethidine after elective laparotomy leading to colectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53382</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be divided into two groups by random allocation method. The balanced (permuted) block randomization will be used for random allocation and patients will be divided into two groups of ketorolac + pethidine and pethidine ; Thus, first 6 possible modes of blocks (BAAB, ABBA, BABA, AABB, ABAB, BBAA) were listed and each block was assigned a number from 1 to 0. Then, a number between 1 and 0 was randomly selected and the subjects were assigned to the experimental group (A) and placebo (B) based on the relevant block and the selected number.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients will be randomly assigned to this group and will receive ketrolac (4 mg) + pethidine (40 mg) intravenously every 8 hours after elective colectomy; The severity of the pain will then be measured using a VAS instrument every eight hours. Intervention 2: Intervention group: Intervention group: Patients will be randomly assigned to this group and will receive  pethidine (40 mg) intravenously every 8 hours after elective colectomy; The severity of the pain will then be measured using a VAS instrument every eight hours.</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>Mehdi Khanbabayi Gol</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Hospital, Azadi Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5981764863</zip>
        <telephone>+98 41 3334 7054</telephone>
        <email>Khanbabayimehdi69@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Khanbabayi Gol</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Hospital, Azadi Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165665631</zip>
        <telephone>+98 41 3334 7054</telephone>
        <email>Khanbabayimehdi69@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Weight between 45 to 115 kg
Candidate elective laparotomy leading to colectomy</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Getting gastritis
Having unknown bleeding disorders
Pregnant women
Opioid addiction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.29</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other chronic pain</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>Intervention group: Patients will be randomly assigned to this group and will receive ketrolac (4 mg) + pethidine (40 mg) intravenously every 8 hours after elective colectomy; The severity of the pain will then be measured using a VAS instrument every eight hours.</i_keyword>
      <i_keyword>Intervention group: Intervention group: Patients will be randomly assigned to this group and will receive  pethidine (40 mg) intravenously every 8 hours after elective colectomy; The severity of the pain will then be measured using a VAS instrument every eight hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: The intervention will start immediately after the end of the surgery and will continue for up to two days after the surgery. The study variable will be measured every six hours from the beginning of the study for three days with the help of VAS instrument. Method of measurement: VAS.</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>2020-01-20</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
