<?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>IRCT20141209020258N93</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-09</date_registration>
      <primary_sponsor>Vice Chancellor For Research,  Arak University Of Medical Science</primary_sponsor>
      <public_title>Comparison of therapeutic effects and its outcomes with morphine against methadone in combination with diazepam and haloperidol in cancer patients with severe and chronic pain referred to emergency ward.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of therapeutic effects and its outcomes with morphine against methadone in combination with diazepam and haloperidol in cancer patients with severe and chronic pain referred to emergency ward.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36399</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple  randomization with random number in division of groups in two groups A and B.Randomized patients are divided into two groups.Randomized allocation in clinical trial studies refers to the process of dividing participants into different groups randomly. Randomizing gives each participant equal odds for being placed in each of the groups.The candidate patients who enter the study are randomly assigned to the randomly assigned table of randomly assigned to the two groups, Blinding description: This study is clinical trial.Outcome elevator and analyzer are blind (double blind).Outcome elevator and analyzer don't aware from grouping.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: We inject 5 milligram Metadon and 5 milligram Haloperidol in muscular and 10 milligram Diazpam intravenous slowly for 5 minute in first group. Intervention 2: Intervention group: We inject slowly 5 milligram Morphine sulphat intravenous.</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:
When we publish article in journal

When:
After the article is published

To whom:
researcher in university

Conditions:
If there are additional questions

Where to obtain:
Dr Simin najafgholian

How to obtain:
They have to write letters to the professors and the university

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Ramin Parvizrad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Hospital, Valiasr squre, Shahid Shirodi street</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3814957558</zip>
        <telephone>+98 86 3222 2003</telephone>
        <email>parvizrad@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Simin Najafgholian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Hospital, Valiasr squre, Shahid Shirodi street</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3814957558</zip>
        <telephone>+98 86 3222 2003</telephone>
        <email>najafgholian@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with metastatic disease of  spine with pain complaints and scurvy of pain 7 and above referring to Emergency hospital of Amiralmomenin and Vali Asr arak Hospital
Non-allergic to benzodiazepine and haloperidol</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unsatisfied patients
Decreased consciousness at the time of referral or during the study
Blood pressure drop of SBP &lt;90 at the time of referral or during the study
There is any contraindication in the administration of opioid or Benzodiazepine or Haloperidol
Patients with scores of pain less than 7
Oxygen saturation below 92%
Heart rate above 90 or under 60</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C80.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm, primary site 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>Intervention group: We inject 5 milligram Metadon and 5 milligram Haloperidol in muscular and 10 milligram Diazpam intravenous slowly for 5 minute in first group.</i_keyword>
      <i_keyword>Intervention group: We inject slowly 5 milligram Morphine sulphat intravenous.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 1 and 24 hours after intervention. Method of measurement: Visual analog scale.</prim_outcome>
      <prim_outcome>Patient satisfaction. Timepoint: 24 hours after intervention. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Side effect of drugs. Timepoint: After intervention. Method of measurement: Observation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Vice Chancellor For Research,  Arak University Of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-10</approval_date>
        <contact_name>Ethics Committe Arak University Of Medical Sciences</contact_name>
        <contact_address>Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
