<?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>IRCT201205099697N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-27</date_registration>
      <primary_sponsor>Golestan University of Medical Sciences</primary_sponsor>
      <public_title>Assessment of the effects of diclofenac suppository and intravenous acetaminophen, and the combination of them, on postoperative pain in patients undergoing spinal anesthesia for cesarean section</public_title>
      <acronym>-</acronym>
      <scientific_title>The effects of diclofenac suppository and intravenous acetaminophen, and the combination of them, on postoperative pain in patients undergoing spinal anesthesia for cesarean section</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10257</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Samples receiving medicine will be divided into three groups with simple random sampling method.</study_design>
      <phase>3</phase>
      <hc_freetext>َAcute Pain.</hc_freetext>
      <i_freetext>Intervention 1: Diclofenac suppositories 100 mg, based on average pain severity of patients evaluated at Hour 0, 2, 4, 6, 12, 24 after local anesthetic in the recovery unit, will be prescribed. Aboureihan Pharmaceutical product. Intervention 2: intravenous acetaminophen 1000mg، based on average pain severity of patients evaluated at Hour 0, 2, 4, 6, 12, 24 after local anesthetic in the recovery unit, will be prescribed. Daroupakhsh Pharmaceutical product. Intervention 3: Combination of diclofenac suppository 100 mg and 500 mg intravenous acetaminophen, based on average pain severity of patients at hour 0, 2, 4, 6, 12, 24 post-local anesthetic in recovery unit, will be prescribed. Aboureihan and DarouPakhsh pharmaceutical products.</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>Fozieh Bakhsha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Anesthesiology, Faculty of Paramedical Sciences, Golestan University of Medical Sciences, Km 4 road Sari-Gorgan, Gorgan, Golestan province, Iran</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>74515-49341</zip>
        <telephone>+98 17 3253 8011</telephone>
        <email>Bakhsha2goums.ac.ir؛ Bakhsha_fo@yahoo.com؛ Bakhshafo@gmail .com</email>
        <affiliation>Golestan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fozieh Bakhsha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>km 4 road Sari Gorgan, Vice Chancellor for Research and Technology, Golestan University of Medical Sciences, Gorgan, Golestan province, Iran</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>74515-49341</zip>
        <telephone>+98 17 3253 8011</telephone>
        <email>Bakhsha2goums.ac.ir؛ Bakhsha_fo@yahoo.com؛ Bakhshafo@gmail .com</email>
        <affiliation>Golestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients with 1 and 2 ASA class of Anesthesia; Term gestational age; absence of chronic diseases such as cardiovascular; hepatic and renal disease. exclusion criteria: hypersensitivity to any drug such as acetaminophen; local anesthetics, having liver or renal disease; diabetes, and patients who used analgesic drugs (opioids, NSAID and corticosteroid)within 8 to 12 hours before the intervention</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>َAcute 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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Diclofenac suppositories 100 mg, based on average pain severity of patients evaluated at Hour 0, 2, 4, 6, 12, 24 after local anesthetic in the recovery unit, will be prescribed. Aboureihan Pharmaceutical product</i_keyword>
      <i_keyword>intravenous acetaminophen 1000mg، based on average pain severity of patients evaluated at Hour 0, 2, 4, 6, 12, 24 after local anesthetic in the recovery unit, will be prescribed. Daroupakhsh Pharmaceutical product</i_keyword>
      <i_keyword>Combination of diclofenac suppository 100 mg and 500 mg intravenous acetaminophen, based on average pain severity of patients at hour 0, 2, 4, 6, 12, 24 post-local anesthetic in recovery unit, will be prescribed. Aboureihan and DarouPakhsh pharmaceutical products</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determination  of pain severity before intervention in patients undergoing spinal anesthesia for cesarean section in diclofenac suppository group in Sayyad Shirazi Hospital of Gorgan. Timepoint: before intervention. Method of measurement: Visual Analogue Scale (VAS).</prim_outcome>
      <prim_outcome>Determination  of pain severity before intervention in patients undergoing spinal anesthesia for cesarean section in intravenous acetaminophen group in Sayyad Shirazi Hospital of Gorgan. Timepoint: before intervention. Method of measurement: Visual Analougue Scale(VAS).</prim_outcome>
      <prim_outcome>Determination of pain severity before intervention in patients undergoing spinal anesthesia for cesarean section in combination of the intravenous acetaminophen and diclofenac suppository group in Sayyad Shirazi Hospital of Gorgan. Timepoint: before intervention. Method of measurement: Visual Analougue Scale (VAS).</prim_outcome>
      <prim_outcome>Determination of pain severity after intervention in patients undergoing spinal anesthesia for cesarean section in group of diclofenac suppository in Sayyad Shirazi Hospital of Gorgan. Timepoint: in hour 0, 2, 4, 6, 12, 24. Method of measurement: Visual Analougue Scale.</prim_outcome>
      <prim_outcome>Determination of pain severity after intervention in patients undergoing spinal anesthesia for cesarean section in group of intravenous acetaminophen in Sayyad Shirazi Hospital of Gorgan. Timepoint: in hour 0, 2, 4, 6, 12,24. Method of measurement: Visual Analougue Scale (VAS).</prim_outcome>
      <prim_outcome>Determination of pain severity after intervention in patients undergoing spinal anesthesia for cesarean section in combination of the intravenous acetaminophen and diclofenac suppository group in Sayyad Shirazi Hospital of Gorgan. Timepoint: in hour 0، 2 ،4 ،6 ،12، 24. Method of measurement: Visual Analougue Scale (VAS).</prim_outcome>
      <prim_outcome>Comparison of pain severity after the intervention in patients undergoing spinal anesthesia for cesarean section groups of acetaminophen, diclofenac, and the combined intravenous acetaminophen and diclofenac suppository in Sayyad Shirazi Hospital of Gorgan. Timepoint: in hour 0, 2, 4, 6, 12, 24. Method of measurement: Visual Analougue Scale (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>Golestan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-03-02</approval_date>
        <contact_name>Ethics committee of Golestan University Of Medical Sciences</contact_name>
        <contact_address>km 4 road Sari Gorgan, Vice Chancellor for Research and Technology, Golestan University of Medical Sciences, Gorgan, Golestan province, Iran Gorgan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
