<?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>IRCT2015052015620N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-17</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Pain management in patients with limb fractures</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy and safety of morphine-ketamine combination in comparison with morphine alone in acute pain management  among patients who admitted to emergency with  limb fracture</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-12-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>192</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14837</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: People who refer to a referral hospital, and after confirmed fracture recruit to enroll one of the A (Morphine) or B (Morphine-Ketamine) groups by non probability sampling available technique and we will use random number table. Neither the patients nor the physicians know about the used analgesics in each group and case.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Upper limb injuries. Condition 2: Lower limb injuries. Condition 3: Pain in limb.</hc_freetext>
      <i_freetext>Intervention 1: In the case of Numerical Rating Score equal or greater than 4, 0.1mg/kg bolus dose of morphine  prescribe. All the variables such as vital signs, side effects, pain scores will check at consequent fifth, tenth, and 20th minutes to find any changes.A group as the control group use morphine sulfate  0.05mg/kg maintenance therapy after a bolus dose of morphine at the beginning. Adverse effects of the prescribed drugs, vital signs, and pain scores  record. The process perform every 20 minutes until the Numerical Rating score fall under 4, or from beginning dose  more than 2 hours past. Intervention 2: In the case of  Numerical Rating Score equal or greater than 4, 0.1mg/kg bolus dose of morphine  prescribe. All the variables such as vital signs, side effects, pain scores will check at consequent fifth, tenth, and 20th minutes to find any changes. In investigation group, ketamine 0.2mg/kg  use with morphine 0.05mg/kg after the first bolus dose of morphine. Adverse effects of the prescribed drugs, vital signs, and pain scores  record. The process perform every 20 minutes until the Numerical rating score fall under 4, or from beginning dose  more than 2 hours past.</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>Zein Alabedin Chaboksavar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 10, Third floor, Lotous  Building, 7th Vahdat َََAve., Banafsheh, Karaj, Alborz, Iran</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 26 3286 1602</telephone>
        <email>Zchaboksavar@Yahoo.com</email>
        <affiliation>Shahid Beheshti  University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majidi Alireza</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tajrish Hospital, Tajrish Sq., Tehran,  Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2271 8000</telephone>
        <email>Pezeshkmajidy@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age between 18 and 50 years, patients with Limbs trauma, Acute pain,  confirmed limb fractures with imaging.&#13;
Exclusion criteria: cases with opium addiction, any analgesic drug consumption prior coming to ED, pregnant women, any allergy to Ketamine or Morphine, history of chronic pain, asthma, renal failure, coronary disease, and unstable hemodynamic status were excluded.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S42.2/ S42</hc_code>
      <hc_code>S72.0/ S72</hc_code>
      <hc_code>M79.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of upper end of humerus,  Fracture of shaft of humerus, Fracture of lower end of humerus, Fracture of shaft of ulna, Fracture of shaft of radius, Fracture of other parts of forearm</hc_keyword>
      <hc_keyword>Fracture of neck of femur, Fracture of shaft of femur, Fractures of other parts of femur, Fracture of upper end of tibia, Fracture of shaft of tibia, Fracture of fibula alone, Fractures of other parts of lower leg</hc_keyword>
      <hc_keyword>Pain in limb</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>In the case of Numerical Rating Score equal or greater than 4, 0.1mg/kg bolus dose of morphine  prescribe. All the variables such as vital signs, side effects, pain scores will check at consequent fifth, tenth, and 20th minutes to find any changes.A group as the control group use morphine sulfate  0.05mg/kg maintenance therapy after a bolus dose of morphine at the beginning. Adverse effects of the prescribed drugs, vital signs, and pain scores  record. The process perform every 20 minutes until the Numerical Rating score fall under 4, or from beginning dose  more than 2 hours past.</i_keyword>
      <i_keyword>In the case of  Numerical Rating Score equal or greater than 4, 0.1mg/kg bolus dose of morphine  prescribe. All the variables such as vital signs, side effects, pain scores will check at consequent fifth, tenth, and 20th minutes to find any changes. In investigation group, ketamine 0.2mg/kg  use with morphine 0.05mg/kg after the first bolus dose of morphine. Adverse effects of the prescribed drugs, vital signs, and pain scores  record. The process perform every 20 minutes until the Numerical rating score fall under 4, or from beginning dose  more than 2 hours past.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Age, Gender, Blood Pressure, Respiratory Rate, Numerical Rating Scale, Pulse Rate, Fracture Type. Timepoint: Fifth, tenth, 20th Minutes  after each drug administration. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Drug side effects. Timepoint: Fifth, tenth, 20th Minutes  after each drug administration. Method of measurement: Questionnaire.</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, Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-06-30</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences,  Tabnak St., Evin, Chamran Highway, Tehran, Iran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
