<?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>IRCT20180725040597N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-31</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Intravenous Paracetamol and Meperidine on shivering after abdominal surgery with general anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Comparisons between effect of Intravenous Paracetamol with Meperidine 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>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33098</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Visitors are randomly divided into three groups, at first 120 envelopes have been prepared that containing 40 of them are written in letter A and 40th letter B and 40th letter C. Drugs are encoded so that the injector and the checklist completes are not aware of the nature of the codes. Medications are injected into the syringes in the same of volume and shape. Technician prepares medication and the researcher did not know the nature of the codes and type of drug. An envelope is selected randomly and injected drug inside of packet then the results are recorded in checklist,, Blinding description: At first three boxes with 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 selected one of the envelopes and injects and records results in checklist.</study_design>
      <phase>2-3</phase>
      <hc_freetext>cholelitiasis and cholesystitis and other disease associated with gallbladder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intravenous Paracetamol ampoule 1gr. Intervention 2: Intervention group: Intravenous Mepridin ampoule 30 mg. Intervention 3: Control group: Normal Saline ampoule with the same of volume and forme.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Age,sex and other personal information

When:
2018/10/01

To whom:
Whole of Professors in university

Conditions:
Whole of Professors in university

Where to obtain:
Ardabil university of science

How to obtain:
Take a permit from university

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Godrat Akhavan Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemi hospital Ardebil</address>
        <city>Ardebil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>56136336810</zip>
        <telephone>+98 45 3324 6063</telephone>
        <email>G.akbari@arums.ac.ir</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Godrat Akhavan Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemi Hospital Ardebil</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5613633681</zip>
        <telephone>+98 45 3324 6063</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)
Patients referred to Ardabil Fatemi Hospital in the range of 20 to 70 years</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 then 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 cholesystitis, 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>Intervention group: Intravenous Paracetamol ampoule 1gr</i_keyword>
      <i_keyword>Intervention group: Intravenous Mepridin ampoule 30 mg</i_keyword>
      <i_keyword>Control group: Normal Saline ampoule with the same of volume and forme.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Check in scale of shivering. Timepoint: Measurement at times 5, 15 minutes after entering the recovery. Method of measurement: Shivering Grading.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Check in scale of postoperative sedation. Timepoint: Measurement at times 5, 15 minuets after entering the recovery. Method of measurement: Ramsay scale.</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>Ethics committee of Ardebil University of Medical Sciences</contact_name>
        <contact_address>No. 35/1,  West Eslami3., Street Moallem Ardebil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
