<?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>IRCT20180615040104N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-01</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>The effect of intravenous ibuprofen and tramadol on shivering after abdominal surgery with general anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Comparisons between effect of intera venous Ibuprofen with Tramadol  for prevention of postoperative shivering with general anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32105</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are randomly divided into three groups. Initially, 120 envelopes will be prepared that 40 with  letters (A) and 40 with letters (B) and 40 envelopes with letters (E) written. The drugs will be encoding, so that the injector And the checklist registrar is not aware of the quiddity of the codes. The drugs are drawn in two Session (in volume of 2 cc) and in the same color of the syringes and the code is recorded on them. The technician outside of the research group prepares drugs and the researcher does not know the quiddity of the codes, type of injectable drugs and drugs are injected according to the selected code. Then an envelope is randomly selected and the drug that containing the code in the envelope is injected to the patient and the results are recorded in the checklist, Blinding description: At first three boxes with codes A, B and C were prepared. Then the medications were given to an anesthetic technician. He was asked to place the vials of each drug in one of the boxes. Vials should be similar and without names. The packets are packed in each group and then the researcher randomly selects one of the envelopes and injects and records the results in checklists.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cholelithiasis, cholecystitis and other diseases associated with gallbladder.</hc_freetext>
      <i_freetext>Intervention 1: Interventions group1: Tramadol ampoule 1 mg / kg. Intervention 2: Interventions group2: intravenous ibuprofen ampoule 800 mg. Intervention 3: Control group: Placebo (normal saline with the same volume and shape with the intervention groups).</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ghodrat Akhavan Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical Univaersity. university Ave.</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>53141-56198</zip>
        <telephone>+98 45 3351 2006</telephone>
        <email>g.akbari@arums.ac.ir</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghodrat Akhavan Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical University. University Ave.</address>
        <city>Ardebil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>53141-56198</zip>
        <telephone>+98 45 3351 2006</telephone>
        <email>g.akbari@arums.ac.ir</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients undergoing cholecystectomy (surgical)
Male patients referred to Ardabil Fatemi Hospital in the range of 20 to 70 year.
Female patients referred to Ardabil Fatemi Hospital in the range of 20 to 70 year.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe cardiovascular disease
Liver and kidney disorders
Peptic ulcer disease
Muscular disease
Patients with history of the blood transfusions or blood products during surgery
Patients with history of seizure
Surgeries with a duration of more than 2 hours</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k808,182</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Calculus of gallbladder with acute cholecystitis, Calculus of gallbladder with other cholecystitis, Calculus of gallbladder without cholecystitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventions group1: Tramadol ampoule 1 mg / kg</i_keyword>
      <i_keyword>Interventions group2: intravenous ibuprofen ampoule 800 mg</i_keyword>
      <i_keyword>Control group: Placebo (normal saline with the same volume and shape with the intervention groups)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Check in scale of shivering. Timepoint: check in scale of post operative shivering based on observation muscle movement in recovery and scored. Method of measurement: score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Check in scale of post operative nausea and vomiting and sedation and pain. Timepoint: check in scale of post operative indication of nausea and vomiting and sedation and pain based on APFEL &amp; RAMSAY score and VAS. Method of measurement: score.</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>Ardabil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-17</approval_date>
        <contact_name>Medical University of Ardebil</contact_name>
        <contact_address>No. 90, Mlek Ashtar Alley, Otobosrani St., Ardebil City Ardebil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
