<?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>IRCT2013100214860N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-10-25</date_registration>
      <primary_sponsor>Research Office of Kurdistan University of Medical Sciences</primary_sponsor>
      <public_title>Davy effects of pethidine and ketamine in preventing postoperative shivering after cesarean section in pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of therapeutic effect of intravenous ketamine low doses versus pethidine on post spinal anesthesia shivering in patients undergoing elective cesarean section</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14334</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Informed consent was obtained from patients undergoing elective cesarean section patients are being enrolled. Vblafaslh drug intravenously after spinal injection is administered. Presence or absence of chills and grade will be determined based on a 4-0 scale.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Shivering after spinal anesthesia in patients undergoing elective cesarean surgery..</hc_freetext>
      <i_freetext>Intervention 1: Pethidine group of 0/5 kg ketamine group and 0/3 kg at equal volume immediately after spinal anesthesia is injected intravenously. Two groups of disposable needles for anesthetic drug bupivacaine 24 and 12 mg dose is used. Intervention 2: In control group, 24 disposable needles for anesthetic drug bupivacaine and 12 mg dose is used unlike the intervention group but no drug (ketamine or pethidine) for prevention of shivering after cesarean section are not receiving.</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>Arman Sarshivi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177-13446</zip>
        <telephone>+98 87 1356 4240</telephone>
        <email>armansarshivi@yahoo.com</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Karim Naseri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177-13446</zip>
        <telephone>+98 87 1666 4654</telephone>
        <email>bihoshi@gmail.com</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: being candidate for cesarean section; fill in consent forms; physical status class I or II in accordance with anesthesia.&#13;
Exclusion Criteria: pregnancy associated with diseases such as  hypertension, diabetes; heart valve disease; coronary artery disease; pulmonary hypertension;pre Eclampsia and Diabetes  mellitus.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>074.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other complications of spinal and epidural anaesthesia during labour and delivery</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>Pethidine group of 0/5 kg ketamine group and 0/3 kg at equal volume immediately after spinal anesthesia is injected intravenously. Two groups of disposable needles for anesthetic drug bupivacaine 24 and 12 mg dose is used.</i_keyword>
      <i_keyword>In control group, 24 disposable needles for anesthetic drug bupivacaine and 12 mg dose is used unlike the intervention group but no drug (ketamine or pethidine) for prevention of shivering after cesarean section are not receiving.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Shivering after spinal anesthesia in patients undergoing elective cesarean. Timepoint: Since spinal anesthesia or intravenous pethidine or ketamine. Method of measurement: Presence or absence of chills and grade them 4-0 is determined based on.Grade zero: no chills. Grade1: mild fasciculation in the face and neck. Grade2: trembling visible muscle groups in more than one category. Grade 3: Zlany activity of the whole body is involved.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Adverse events (nausea, vomiting, nystagmus, hypotension requiring treatment, bradycardia requiring medication. Timepoint: Any complications during the surgery and recovery if the questionnaire is. Method of measurement: Based on history and physical examination and observation.</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>Research Office of Kurdistan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-08-06</approval_date>
        <contact_name>Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Kurdistan University of Medical Sciences, Opposite Hotel Shadi, Campus sanandaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
