<?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>IRCT2015122225660N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-02-28</date_registration>
      <primary_sponsor>Vice chancellor for research,Arak University of Medical Sciences</primary_sponsor>
      <public_title>analgesic effect of intravenous ketamine</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of analgesic effect of intravenous ketamine versus intravenous Morphine in isolated orthopedic trauma patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>606</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21415</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Drugs were labeled by a study investigator as A or B in prefilled syringes in which both drug diluted until 0.1 milliliter of each syringe serve desired dose of the agent. We used 0.1 mg/kg dosage for morphine and 0.25 mg/kg for ketamine group. The eligible patients will  be simply randomized in two treatment groups by using of randomized numbers table. The medication was administered by intravenous infusion during 5 minutes by registered treating nurse in a blinded fashion.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Upper or Lower limb fracture. Condition 2: Upper or Lower limb dislocation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention1 (case group): In Group A, patients receive a dose of 0.25 mg / kg iv ketamine. Drugs’ dose are calculated based on patient weight. Pain severity base on visual analog score (VAS) and complication such as dizziness, nausea, amnesia, headache, will be recorded at 0th, 5th, 10th and 20th minute. In patients with VAS of pain more than 50 mm at 20th minute, 0.05 mg/kg of intravenous morphine will be administrated as rescue analgesia . Intervention 2: Intervention2 (case group): In Group B, patients receive a dose of 0.1 mg / kg iv morphine. Drugs’ dose are calculated based on patient weight. Pain severity base on visual analog score (VAS) and complication such as dizziness, nausea, pain, amnesia, headache, will be recorded at 0, 5th, 10th and 20th minute. In patients with VAS of pain more than 50 mm at 20th minute, 0.05 mg / kg of intravenous morphine will be administrated as rescue analgesia.</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>Ramin Parvizrad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Department, Vali-asr Hospital, Valiasr square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3222 0003</telephone>
        <email>r.parvizrad@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ramin Parvizrad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Department, Vali-asr Hospital, Valiasr square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3222 0003</telephone>
        <email>r.parvizrad@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients with isolated trauma with fracture in the upper or lower extremities; aged between 15 and 55 years old; with Visual Analogue Scale pain score of more than 50 mm. &#13;
Exclusion criteria: Patient’s refusal to participate in the study; having an underlying medical condition such as migraine, cardiac ischemia, schizophrenia, history of allergy to opiates or ketamine, head trauma or loss of consciousness; blood pressure of more than 180/100; vital signs Instability before and during the study; pregnancy; any inability to express their pain during the study; presence of other trauma.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T10, T12</hc_code>
      <hc_code>T11.2, T13</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of upper limb, level unspecified, Fracture of lower limb, level unspecified</hc_keyword>
      <hc_keyword>Dislocation, sprain and strain of unspecified joint and ligament of upper limb or lower limb, level 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>Intervention1 (case group): In Group A, patients receive a dose of 0.25 mg / kg iv ketamine. Drugs’ dose are calculated based on patient weight. Pain severity base on visual analog score (VAS) and complication such as dizziness, nausea, amnesia, headache, will be recorded at 0th, 5th, 10th and 20th minute. In patients with VAS of pain more than 50 mm at 20th minute, 0.05 mg/kg of intravenous morphine will be administrated as rescue analgesia .</i_keyword>
      <i_keyword>Intervention2 (case group): In Group B, patients receive a dose of 0.1 mg / kg iv morphine. Drugs’ dose are calculated based on patient weight. Pain severity base on visual analog score (VAS) and complication such as dizziness, nausea, pain, amnesia, headache, will be recorded at 0, 5th, 10th and 20th minute. In patients with VAS of pain more than 50 mm at 20th minute, 0.05 mg / kg of intravenous morphine will be administrated as rescue analgesia.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain severity. Timepoint: 0,  5th,10th, 20th minute. Method of measurement: Visual analog scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dizziness, nausea, burning throat, amnesia, headache,. Timepoint: Before intervention, 5, 10 and 20 minutes after intervention. Method of measurement: physical examination.</sec_outcome>
      <sec_outcome>Need for rescue analgesia. Timepoint: 20 minutes after intervention. Method of measurement: Visual analog scale of pain.</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 Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-02-03</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>A'lam-Al-Hoda Street, Shahid Shiroodi Street Arak  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
