<?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>IRCT201501223213N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-03-01</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of acetaminophen with combination of diclofenac and incisional bupivacaine in controlling pain after Cesarean section</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of the effect of intravenous acetaminophen with diclofenac suppository and incisional bupivacain combination on the first 24hour postoperative pain after cesarian section</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3268</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>Pain after cesarian section.</hc_freetext>
      <i_freetext>Intervention 1: Before starting surgery patients in group A (acetaminophen) will receive a suppository placebo an then two other doses, all 8 hr apart. At the end of the procedure a 0.6 ml/kg normal saline (as placebo) will be injected in their incision area. On arrival to recovery room 15 mg/kg acetaminophen in 100 ml normal saline will be administered, intravenously and this will be repeated two more times, 8 hours apart. Intervention 2: Before starting surgery patients in group B (diclofenac + bupivacaine) will receive a suppository diclofenac (50 mg) an then two other doses, all 8 hr apart. At the end of the procedure 1.5 mg/kg bupivacaine 0.25% will be injected in their incision area. On arrival to recovery room 100 ml normal saline will be administered, intravenously.</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>Arash Farbood</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology Department, Faghihi Hospital, Zand Boulevard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3628 9630</telephone>
        <email>farboda@sums.ac.ir; arashfarbood@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arash Farbood</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology Department, Faghihi Hospital, Zand Boulevard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3628 9630</telephone>
        <email>farboda@sums.ac.ir; arashfarbood@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: full-term pregnant women candidate for elective cesarean section; age: 18 to 45 years;ASA class1 and 2; between 50 to 80kg weight &#13;
&#13;
Exclusion criteria : strong indication for spinal anesthesia; emergency cesarean section; opioid addiction; anxiety and depressive disorders; gastro-esophageal reflux disease; severe renal disease; heart disease&#13;
liver disease; seizure disease; positive history of hypersensitivity to the drugs used in the study; analgesic consumption in the last 24 hr; non-cooperative patients</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O82.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Delivery by cesarean section, unspecified</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>Before starting surgery patients in group A (acetaminophen) will receive a suppository placebo an then two other doses, all 8 hr apart. At the end of the procedure a 0.6 ml/kg normal saline (as placebo) will be injected in their incision area. On arrival to recovery room 15 mg/kg acetaminophen in 100 ml normal saline will be administered, intravenously and this will be repeated two more times, 8 hours apart.</i_keyword>
      <i_keyword>Before starting surgery patients in group B (diclofenac + bupivacaine) will receive a suppository diclofenac (50 mg) an then two other doses, all 8 hr apart. At the end of the procedure 1.5 mg/kg bupivacaine 0.25% will be injected in their incision area. On arrival to recovery room 100 ml normal saline will be administered, intravenously.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Every 6 hr in the first 24 hr after cesarian section. Method of measurement: NRS score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>24 hr morphine consumption. Timepoint: Once, 24 hr after operation. Method of measurement: Total dose of morphine administered (mg).</sec_outcome>
      <sec_outcome>Time to first request for analgesic after operation. Timepoint: Once after the procedure. Method of measurement: Time interval from the end of the surgery to the first patient's request for analgesic (minute).</sec_outcome>
      <sec_outcome>Patient's sleep. Timepoint: Next morning after operation. Method of measurement: 3 point scale: 1: good - 2: interrupted - 3: no sleep.</sec_outcome>
      <sec_outcome>Sedation score. Timepoint: Every 6 hr after operation till 24 hr. Method of measurement: Wilson scale.</sec_outcome>
      <sec_outcome>Pain intensity at ambulation. Timepoint: Once during ambulation. Method of measurement: NRS.</sec_outcome>
      <sec_outcome>Drug side effects: nausea and vomiting. Timepoint: Every 6 hr after operation till 24 hr. Method of measurement: 3 points scale: 1: non, 2: nausea, 3: nausea and vomiting.</sec_outcome>
      <sec_outcome>Patients satisfaction of pain control. Timepoint: Once, 24 hr after operation. Method of measurement: 11 points NRS (0: extremely dissatisfied, 5: neutral, and 10: most satisfied).</sec_outcome>
      <sec_outcome>Drug side effects: pruritus. Timepoint: Every 6 hr till 24 hr after operation. Method of measurement: 11 points NRS.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-11-16</approval_date>
        <contact_name>Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz University of Medical Sciences, Zand Boulevard Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
