<?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>IRCT20181006041248N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-05</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the Effect of Oxycodone Pills on Shivering Control</public_title>
      <acronym></acronym>
      <scientific_title>Comprasion of Effectiveness Oxycodone Pills and Pethidine Ampoule in Control of Patient’s Shivering after Ingueinal Hernioraphy followed by Spinal Anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37234</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Prevention, Randomization description: Patients will be prepared randomly assigned in two Groups: Pethidine and Oxycodone. This is two blinded study. Each morning before surgery, the Number of Surgeries and the Number of Medications required by the Prescriber will be Available.There will be two Envelopes. Case A has Pethidine and Placebo Pills and the Envelope B contains a Syringe containing Normal Saline and an Oxycodone Pill. Any Disease based on the Code A or B they will receive these Envelopes. The Prescription is prescribed before Surgery, Blinding description: This Study is a Double Blind Clinical Trial. In this Study, 110 Patients were diagnosed with Inguinal Hernia for Random Allocation of Pethidine and Oxycodone each Day before Surgery the Number of Surgeries and the Number of required by the Presenter the Plan will be ready. There will be two types of Envelopes. Case A has Pethidine and Placebo Pills and the Envelope B contains a Syringe containing Normal Saline and an Oxycodone Pill. Any Disease based on the Code A or B they will receive these Envelopes. The Prescription is prescribed before Surgery.</study_design>
      <phase>3</phase>
      <hc_freetext>Shivering.</hc_freetext>
      <i_freetext>Intervention group: There will be two types of envelopes: Packet A with pethidine syringe and placebo tablets, and B envelope with syringes containing normal saline and oxycodon. Pethidine will be given 0.4 mg / kg immediately after spinal anesthesia and oxycodone 5 mg tablet half an hour before surgery.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saman Hayadokht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ardebil- Azadegan Town- Second Alley- Second Block-plaque 51</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5617693844</zip>
        <telephone>+98 45 3372 5915</telephone>
        <email>S.Hayadokht@arums.ac.ir</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghodrat Akhavanakbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ardabil University of Medical Sciences</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۵۶۱۸۹-۸۵۹۹۱</zip>
        <telephone>+98 45 3352 2252</telephone>
        <email>G.Akhavanakbari@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 ASA  I,II
Patients who have been diagnosed with Inguinal Hernia after Spinal Anesthesia and have been Shivering</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of Allergy to Pethidine or Oxycodone
History of Peptic Ulcer, Systemic Infection, or Immune Deficiency
History of Taking MAO Inhibitors
Untreated Hypothyroidism
Benign Prostatic Hypertrophy
Addison Diseases
Uterine Stenosis
Seizure Disorders
Patients who have had Significant Bleeding during Surgery
Patients who do not have Spinal Anesthesia and become ansthetized
Under 18 years of age
over 65 years old</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T 88.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other complication of anesthesia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: There will be two types of envelopes: Packet A with pethidine syringe and placebo tablets, and B envelope with syringes containing normal saline and oxycodon. Pethidine will be given 0.4 mg / kg immediately after spinal anesthesia and oxycodone 5 mg tablet half an hour before surgery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Incidence of shivering during surgery and after surgery. Timepoint: During surgery, in recovery and in section. Method of measurement: Observation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nausea and vomiting. Timepoint: 1, 6, 12 and 24 hour intervals. Method of measurement: Question from the patient.</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>2017-12-10</approval_date>
        <contact_name>Ethics Committee of Ardabil University of Medical Sciences</contact_name>
        <contact_address>Ardabil, Azadegan Town, Second Block, Second Alley Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
