<?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>IRCT2013022512593N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-12-04</date_registration>
      <primary_sponsor>Ahvaz Jundishapur University of Medical Sciences (AJUMS)</primary_sponsor>
      <public_title>Reducing the acute pain and the need to narcotic pain relievers after cesarean surgery</public_title>
      <acronym></acronym>
      <scientific_title>A comparison of the effects of diclofenac sodium suppositories, intravenous paracetamol and the combination of diclofenac sodium suppositories and intravenous paracetamol on reducing the acute pain and the need to narcotic pain relievers after cesarean surgery under spinal anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>99</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12638</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cesarean surgery.</hc_freetext>
      <i_freetext>Intervention 1: Second group will receive 1 gr intravenous paracetamol in 500 cc normal saline while entering the recovery and then they will receive 3gr intravenous paracetamol via PCA pomp plus one placebo suppository while leaving the recovery room. Intervention 2: First group will receive 100 mg Diclofenac sodium suppositories when entering the recovery and then they will receive 100 cc Normal saline via PCA pomp. Intervention 3: Third group will receive 1 gr intravenous paracetamol in 500 cc normal saline while entering the recovery and then they will receive 3gr intravenous paracetamol via PCA pomp plus a diclofenac 100 mg suppository.</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>Dr. Gholamreza Safari Hezarvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan bulevard, University Pardise,</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 1332 3175</telephone>
        <email>safari.r@ajums.ac.irreza.safari79@gmail.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences (AJUMS)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Gholamreza Safari Hezarvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan bulevard, unevrsity pardis,</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 1332 3175</telephone>
        <email>safari.r@ajums.ac.irreza.safari79@gmail.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Being in ASA class 1 or 2; Being in ages between 18-35; Being first or second pregnancy.&#13;
&#13;
Exclusion criteria: Having any known allergies and sensitivities, banned from narcotic drugs, paracetamol, and NSAIDs; Hepatic Dysfunction (transaminaze twice than upper limit of normal level); Kidney dysfunction (plasma creatinine higher than 2.5 mg/dl); Smoking or having any previous pulmonary disease; Drug, narcotic, and alcohol abuse; Subjects with the history of depression or chronic anxiety;	Subjects experienced the side effects of spinal anesthesia: back pain, radicular pain, paresthesia and hypoesthesia, PDPH; Spinal contraindication; Contraindications for the Use of Spinal Anesthesia (Patient decline, infection in the spot for entering the needle, high intracranial pressure, bleeding susceptibility).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Maternal care for known or suspected malpresentation of fetus</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>Second group will receive 1 gr intravenous paracetamol in 500 cc normal saline while entering the recovery and then they will receive 3gr intravenous paracetamol via PCA pomp plus one placebo suppository while leaving the recovery room.</i_keyword>
      <i_keyword>First group will receive 100 mg Diclofenac sodium suppositories when entering the recovery and then they will receive 100 cc Normal saline via PCA pomp.</i_keyword>
      <i_keyword>Third group will receive 1 gr intravenous paracetamol in 500 cc normal saline while entering the recovery and then they will receive 3gr intravenous paracetamol via PCA pomp plus a diclofenac 100 mg suppository</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patient reported  pain level. Timepoint: 1, 4, 12, and 24 hours after surgery. Method of measurement: Visual Analog Scale for Pain (VAS Pain).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Intravenous Morphine. Timepoint: in periods of 0-4; 4-12; and 12-24 hours after surgey. Method of measurement: intravenous morphine dose (mg/kg).</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>Ahvaz Jundishapur University of Medical Sciences (AJUMS)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-09-28</approval_date>
        <contact_name>morality in research committee</contact_name>
        <contact_address>Ahvaz Jondishapur University of medical Sciences Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
