<?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>IRCT2015052622423N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-10-21</date_registration>
      <primary_sponsor>Vice chancellor for research Ahvaz  Jundishapoor Univercity of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of Analgesic effect of intravenous lidocaine versus intravenous morphine sulfate in pain reduction in long or short bones fractures of upper and lower limbs</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Analgesic effect of intravenous lidocaine versus intravenous morphine sulfate in pain reduction in long or short bones fractures of upper and lower limbs</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>280</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19341</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization is accomplished with sealed envelopes.Both lidocaine and morphine are colorless and odorless.To homogenize their volume, drugs are vaccumed in a 10 cc syringe according to the name of the drug, which is inside the sealed envelope by a person other then the drug administrator and the total volume is raised up to 10 cc with distilled water.then it would be injected to the patient by administrator.The administrator is unawar of type of drug .</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Fracture. Condition 2: farcture. Condition 3: fracture. Condition 4: Fracture. Condition 5: fracture. Condition 6: fracture. Condition 7: fracture.</hc_freetext>
      <i_freetext>Intervention 1: Control group:Intra venous morphine 0.1mg/kg bolus during 2 minutes. Intervention 2: Intervention group:Intra venous Lidocaine 1.5 mg/kg bolus during 2 minutes.</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>Hamide Shiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadegan sreert, Imam khomeini hospital, Ahwaz city</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 613332477</telephone>
        <email>shiri.h.@ajums.ac.ir؛tufan16671@yahoo.com</email>
        <affiliation>Ahvaz Jundishapoor University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Arash Forouzan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadegan sreert, Imam khomeini hospital, Ahwaz city</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 61 3333 2477</telephone>
        <email>Arash-Forouzan@ajums.ac.ir</email>
        <affiliation>Ahwaz Jundishapoor univercity of medical science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteris : All patients 15-65 years of age with long or short upper or lower bone fracture, referring to  emergency ward of Imam Khomeini  and Golestan hospital in Ahwaz city.&#13;
Exclusion criterias: Persons under 15 years; People over 65 years; Pregnant and lactating women; People with loss of consciousness; Hemodynamic disorder ; Traumatic patients with evidence of intra abdominal or intra pelvic hemorrhage ; mental retard patients; History of allergy to lidocaine or morphine; People treated with NA; People with underlying disease (Coronary artery disease ; Diabetes; Heart valvular disease; history of Cardiac arrhythmia; Hypertention; Cerebrovascular disease; seizure; history of liver or renal disease); history of heart drugs; history of addiction</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S52</hc_code>
      <hc_code>S62</hc_code>
      <hc_code>S00-T98</hc_code>
      <hc_code>S42</hc_code>
      <hc_code>S72</hc_code>
      <hc_code>S82</hc_code>
      <hc_code>S92</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of forearm</hc_keyword>
      <hc_keyword>Fracture at wrist and hand level</hc_keyword>
      <hc_keyword>Other fractures of long or short bones</hc_keyword>
      <hc_keyword>Fracture of shoulder and upper arm</hc_keyword>
      <hc_keyword>Fracture of femur</hc_keyword>
      <hc_keyword>Fracture of lower leg, including ankle</hc_keyword>
      <hc_keyword>Fracture of foot, except ankle</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>Control group:Intra venous morphine 0.1mg/kg bolus during 2 minutes</i_keyword>
      <i_keyword>Intervention group:Intra venous Lidocaine 1.5 mg/kg bolus during 2 minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 0-5-10-15-20-25-30-minute. Method of measurement: vas score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: 0-10-15-20-25-30 minute. Method of measurement: with manometer.</sec_outcome>
      <sec_outcome>Pulse rate. Timepoint: 0-10-15-20-25-30 minute. Method of measurement: Count per minute.</sec_outcome>
      <sec_outcome>Spo2. Timepoint: 0-10-15-20-25-30 minute. Method of measurement: with pulse oximetry.</sec_outcome>
      <sec_outcome>Respiratory rate. Timepoint: 0-10-15-20-25-30 minute. Method of measurement: Count per minute.</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 Ahvaz  Jundishapoor Univercity of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-09</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundi shapoor University of Medical Sciences</contact_name>
        <contact_address>Ground floor, Vice Chancellor for research of Ahwaz Jundishapoor University of Medical Sciences,univercity city, Ahwaz city Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
