<?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>IRCT201205139585N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-12-18</date_registration>
      <primary_sponsor>Vice chancellor for research, Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of analgesic effect of ُsuppositories after cesarean section</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of analgesic effect of Diclofenac, Indomethacin. Naproxen and Acetaminophen suppository after cesarean section </scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10158</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Pain after cesarean section.</hc_freetext>
      <i_freetext>Intervention 1: Indomethacin intervention: A trained personnel without knowing the name of the medication checks the patient's vital signs on arrival in the recovery room, and then a 100 mg Indomethacin suppository (made by Caspian Tamin with brand name of INDIC) is administered as a stat dose. Patient's pain is evaluated by Visual Analogue Scale after drug administration, 15 minutes after drug administration, and an hour later. Intervention 2: Naproxen Intervention: A trained personnel without knowing the name of the medication checks the patient's vital signs on arrival in the recovery room, and then a 500 mg Naproxen suppository (made by Abureyhan Company) is administered as a stat dose. Patient's pain is evaluated by Visual Analogue Scale after drug administration, 15 minutes after drug administration, and an hour later. Intervention 3: Diclofenac intervention:&#13;
a trained personnel without knowing the name of the medication checks the patient's vital signs on arrival in the recovery room, and then a 100 mg  Diclofenac suppository (made by Mahandaroo Company) is administered as a stat dose. Patient's pain is evaluated by Visual Analogue Scale after drug administration, 15 minutes after drug administration, and an hour later. Intervention 4: Acetaminophen intervention: a trained personnel  without knowing the name of the medication checks the patient's vital signs on arrival in the recovery room, and then a 325mg Acetaminophen suppository (made by Abureyhan Company) is administered as a stat dose. Patient's pain is evaluated by Visual Analogue Scale after drug administration, 15 minutes after drug administration, and an hour later.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Matin Hashemi Shadmehri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Afzalipor Hospital Emam Khomeini Highway</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618113467</zip>
        <telephone>+98 34 1282 0361</telephone>
        <email>matinhashemi60@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ali Barkhori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa Street. Shafa Hospital</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618751151</zip>
        <telephone>+98 34 1211 5806</telephone>
        <email>a_barkhori@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria: primi gravid, term fetus, 37 week or more pregnancy and patients with 20 to 45 years old and weight of 60 to 80 kg  indicated for elective surgery. The exclusion criteria: History of allergy to NSAIDs , Bronchial asthma , History of abdominal surgery, Opium addiction , Previous cesarean section, Hemorrhoid , Proctitis , gestational hypertension,  preeclampsia, Bleeding tendency, Gastric ingestion ulcers, liver and kidney disease , Patients that refuse to follow the study or severity of their pain needs use of opioid or other analgesics</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R10.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pelvic and perineal pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Indomethacin intervention: A trained personnel without knowing the name of the medication checks the patient's vital signs on arrival in the recovery room, and then a 100 mg Indomethacin suppository (made by Caspian Tamin with brand name of INDIC) is administered as a stat dose. Patient's pain is evaluated by Visual Analogue Scale after drug administration, 15 minutes after drug administration, and an hour later.</i_keyword>
      <i_keyword>Naproxen Intervention: A trained personnel without knowing the name of the medication checks the patient's vital signs on arrival in the recovery room, and then a 500 mg Naproxen suppository (made by Abureyhan Company) is administered as a stat dose. Patient's pain is evaluated by Visual Analogue Scale after drug administration, 15 minutes after drug administration, and an hour later.</i_keyword>
      <i_keyword>Diclofenac intervention:&#13;
a trained personnel without knowing the name of the medication checks the patient's vital signs on arrival in the recovery room, and then a 100 mg  Diclofenac suppository (made by Mahandaroo Company) is administered as a stat dose. Patient's pain is evaluated by Visual Analogue Scale after drug administration, 15 minutes after drug administration, and an hour later.</i_keyword>
      <i_keyword>Acetaminophen intervention: a trained personnel  without knowing the name of the medication checks the patient's vital signs on arrival in the recovery room, and then a 325mg Acetaminophen suppository (made by Abureyhan Company) is administered as a stat dose. Patient's pain is evaluated by Visual Analogue Scale after drug administration, 15 minutes after drug administration, and an hour later.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain severity. Timepoint: after drug administration, 15 minutes after drug administration, and an hour later. Method of measurement: Visual Analogue 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>Vice chancellor for research, Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-02-19</approval_date>
        <contact_name>Ethic Committee of Vice chancellor for research, Kerman University of Medical Science</contact_name>
        <contact_address>Shafa Street , Shafa Cross Road Kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
