<?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>IRCT20160602028225N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-29</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of intravenous paracetamol on pain during and after prostate surgery.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of intravenous paracetamol before surgery on the dose of opioid during and after radical prostatectomy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48436</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we use the block randomization method to create equal groups.
To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks.
1. TTCC 2. TCTC 3. TCCT
4. CCTT 5. CTCT 6. CTTC
For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit. Here, based on the block, we divide 4 people into groups, Blinding description: The researcher and the person analyzing the study information are unaware of the study groups and are identified as groups A and B.</study_design>
      <phase>3</phase>
      <hc_freetext>Prostate Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first group, intravenous paracetamol will be injected at a rate of one gram, and then one gram will be given one hour after the anesthesia injection.  During surgery, the amount of injectable fentanyl (500 micrograms per 10 cc ampoule made by Caspian Pharmaceutical Company) is based on the patient's weight every hour during the operation, as well as the injected petidine (50 mg per cc made by Caspian Pharmaceutical Company) based on VAS will be determined and recorded for the patient. Also, the severity of pain after surgery will be determined and recorded at recovery times, 2, 8, and 24 hours after recovery. Also, the prescribed dose of opioids will be determined during the 24 hours after the operation at the time of hospitalization, and finally the total length of hospital stay will be determined. Intervention 2: Control group: In the second group, the placebo will be injected at a rate of one gram, and then one gram will be given an hour after the anesthesia injection.During surgery, the amount of injectable fentanyl (500 micrograms per 10 cc ampoule made by Caspian Pharmaceutical Company) is based on the patient's weight every hour during the operation, as well as the injected petidine (50 mg per cc made by Caspian Pharmaceutical Company) based on VAS will be determined and recorded for the patient. Also, the severity of pain after surgery will be determined and recorded at recovery times, 2, 8, and 24 hours after recovery. Also, the prescribed dose of opioids will be determined within 24 hours after the operation at the time of hospitalization, and finally the total length of hospital stay will be determined.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Mohaghegh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1433933111</zip>
        <telephone>+98 21 8864 4411</telephone>
        <email>mohaghegh_mr@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Mohaghegh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1433933111</zip>
        <telephone>+98 21 8864 4411</telephone>
        <email>mohaghegh_mr@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 40 years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>History of chronic drug use
Liver disorder
Kidney disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C61</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of prostate</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: In the first group, intravenous paracetamol will be injected at a rate of one gram, and then one gram will be given one hour after the anesthesia injection.  During surgery, the amount of injectable fentanyl (500 micrograms per 10 cc ampoule made by Caspian Pharmaceutical Company) is based on the patient's weight every hour during the operation, as well as the injected petidine (50 mg per cc made by Caspian Pharmaceutical Company) based on VAS will be determined and recorded for the patient. Also, the severity of pain after surgery will be determined and recorded at recovery times, 2, 8, and 24 hours after recovery. Also, the prescribed dose of opioids will be determined during the 24 hours after the operation at the time of hospitalization, and finally the total length of hospital stay will be determined.</i_keyword>
      <i_keyword>Control group: In the second group, the placebo will be injected at a rate of one gram, and then one gram will be given an hour after the anesthesia injection.During surgery, the amount of injectable fentanyl (500 micrograms per 10 cc ampoule made by Caspian Pharmaceutical Company) is based on the patient's weight every hour during the operation, as well as the injected petidine (50 mg per cc made by Caspian Pharmaceutical Company) based on VAS will be determined and recorded for the patient. Also, the severity of pain after surgery will be determined and recorded at recovery times, 2, 8, and 24 hours after recovery. Also, the prescribed dose of opioids will be determined within 24 hours after the operation at the time of hospitalization, and finally the total length of hospital stay will be determined.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of pain. Timepoint: Before and after surgery. Method of measurement: Visual analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Doses of opioids. Timepoint: During and after surgery. Method of measurement: File registration.</sec_outcome>
      <sec_outcome>Hospital length. Timepoint: After surgery. Method of measurement: Hospital follow-up.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-16</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
