<?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>IRCT20180425039418N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-29</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Paracetamol versus Ketorolac on Postoperative Pain of Cesarean Section</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Paracetamol versus Ketorolac on Postoperative Pain of Cesarean Section</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31875</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The first parity pregnant women who were candidates for elective cesarean were randomly assigned to two groups one of which was treated with paracetamol and the other one was treated with ketorolac, Blinding description: Paracetamol and Ketorolac drug packs are in homogeneous units so that the names of the medications are hidden and only the code is written on the drug units and the researcher is aware of the drug codes and will only give the nurse the name of the medicine in the event of an emergency situation.</study_design>
      <phase>2-3</phase>
      <hc_freetext>post-Cesarean pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Group A paracetamol is injected at a time of zero 1000 mg. Each ampoule of 7.6 mg paracetamol (appendix) contains 1000 mg of acetaminophen, which dissolves each ampoule in 100 ml of normal saline and is injected intravenously within 15 minutes. The pain score is recorded at the injection time of 24, 12, 6, 0, and for every 8 hours 1000 mg of this drug is injected to reach the 24-hour period. Intervention 2: Intervention group 2: Group B, 30 mg intravenous injection of ketorolac is injected in at least 15 seconds, and then the pain score is recorded at the injection time of 24,12,6,0. At the end, each patient is evaluated for visual signs and visual inspection criteria at 0, 6, 12 and 24 hours after medication administration and evaluated and compared using the VAS form. Regarding ethical considerations and respect for patients' rights. Despite the use of paracetamol and ketorolac, the patient still has pain and VAS greater than 3, 25 mg pitadine is given intravenously to the patient and the time of the first application of pethidine, the total amount of pitadine received is recorded. And in the event of any problems and complications (nausea, vomiting, hypotension, etc.), we will treat the patient immediately.</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 no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Maryam Razavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Hesabi square campus of medical sciences</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>98167-43175</zip>
        <telephone>+98 543329571522</telephone>
        <email>Dr.razavi351@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Razavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr.Hesabi square campus of medical sciences</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>98167-43175</zip>
        <telephone>+98 54 3329 5620</telephone>
        <email>Dr.razavi351@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All  women who are at  the term gestational age with the first pregnancy
who are candidates for termination of pregnancy by elective cesarean section</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The mothers who have the chronic disorders such as Lupus erythematosus</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O82</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for cesarean delivery without indication</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 1: Group A paracetamol is injected at a time of zero 1000 mg. Each ampoule of 7.6 mg paracetamol (appendix) contains 1000 mg of acetaminophen, which dissolves each ampoule in 100 ml of normal saline and is injected intravenously within 15 minutes. The pain score is recorded at the injection time of 24, 12, 6, 0, and for every 8 hours 1000 mg of this drug is injected to reach the 24-hour period.</i_keyword>
      <i_keyword>Intervention group 2: Group B, 30 mg intravenous injection of ketorolac is injected in at least 15 seconds, and then the pain score is recorded at the injection time of 24,12,6,0. At the end, each patient is evaluated for visual signs and visual inspection criteria at 0, 6, 12 and 24 hours after medication administration and evaluated and compared using the VAS form. Regarding ethical considerations and respect for patients' rights. Despite the use of paracetamol and ketorolac, the patient still has pain and VAS greater than 3, 25 mg pitadine is given intravenously to the patient and the time of the first application of pethidine, the total amount of pitadine received is recorded. And in the event of any problems and complications (nausea, vomiting, hypotension, etc.), we will treat the patient immediately.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post-cesarean pain. Timepoint: the first time of pain sensation after surgery, 6 hours after the surgery, 12 hours after surgery, 24 hours after surgery. Method of measurement: VAS visual acuity scale.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-04</approval_date>
        <contact_name>Ethics committee of Zahedan University of medical sciences</contact_name>
        <contact_address>Medical Sciences Campus, Doctor Hesabi Square, Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
