<?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>IRCT201206289162N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-04-21</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of intranasal Ketamine on digital nerve block pain</public_title>
      <acronym></acronym>
      <scientific_title>Double-blinded placebo-control study of intranasal ketamin effects and complications in digital nerve block in traumatic hand injuries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>0</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9769</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Local Anesthesia of Digital Nerve.</hc_freetext>
      <i_freetext>Intervention 1: Control group: 2 cc identical syringes contain 1cc Ketamine(=50mg) or 1cc distilled water prepared out of emergency department in blocks of 12. In control group 1 cc of distilled water will drop in one of nostrils of patients and ask them to hold their breath as could as possible and do not cough. All patients will observe for another 30 minutes for probable complications. Intervention 2: Intervention group: 2 cc identical syringes contain 1cc Ketamine(=50mg) or 1cc distilled water prepared out of emergency department in blocks of 12. In intervention group 1 cc of Ketamine (=50 mg) will drop in one of nostrils of patients and ask them to hold their breath as could as possible and do not cough. All patients will observe for another 30 minutes for probable complications.</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>Amir Nejati M.D.</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Department, Imam Hospital, Bagherkhan street, Tohid square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439633761</zip>
        <telephone>+98 21 6119 2240</telephone>
        <email>anejati@tums.ac.ir, nejati.am@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Nejati M.D.</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Department, Imam Khomeini Hospital, Bagherkhan Street, Tohid square,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439633761</zip>
        <telephone>+98 21 6119 2240</telephone>
        <email>anejati@tums.ac.ir, nejati.am@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Hand fingers trauma needed to digital nerve block for procedures; patients who signed the consent form&#13;
Exclusion criteria:&#13;
Age under 15; Can not communicate because of mental retardation; language barriers, loss of consciousness, intoxication or other causes; Pregnancy; Hemodynamic instability (systolic BP less than 90 or more than 180 mmHg); Chronic opium user or use any of sedative-analgesic in last 12 hours; Known reactive or anatomic airway diseases; Decompensated heart failure or acute coronary syndrome (based on History and physical exam OR documentations)&#13;
; Known allergy to Ketamine or Lidocaine.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y48.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Local anaesthetics</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: 2 cc identical syringes contain 1cc Ketamine(=50mg) or 1cc distilled water prepared out of emergency department in blocks of 12. In control group 1 cc of distilled water will drop in one of nostrils of patients and ask them to hold their breath as could as possible and do not cough. All patients will observe for another 30 minutes for probable complications.</i_keyword>
      <i_keyword>Intervention group: 2 cc identical syringes contain 1cc Ketamine(=50mg) or 1cc distilled water prepared out of emergency department in blocks of 12. In intervention group 1 cc of Ketamine (=50 mg) will drop in one of nostrils of patients and ask them to hold their breath as could as possible and do not cough. All patients will observe for another 30 minutes for probable complications.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain of injured finger. Timepoint: entrance, after instillation of drug or placebo (pre-procedural pain), after completion of procedure (post-procedure pain). Method of measurement: Numeric Rating Scale (NRS) 10 part.</prim_outcome>
      <prim_outcome>Complication of control or placebo drug. Timepoint: continouesly from initial instillation of drug until 30 min after procedure. Method of measurement: Ketamine complication such as Hallucination, Nausea, vomiting, hypertension, agitation and seizure.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart Rate. Timepoint: Before instilation and 30 min after that. Method of measurement: By pulse-oxymeter or Cardiac monitor.</sec_outcome>
      <sec_outcome>Systolic BP. Timepoint: Before instilation and 30 min after that. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Arterial O2 Saturation. Timepoint: Before instilation and 30 min after that. Method of measurement: By pulse-oxymeter.</sec_outcome>
      <sec_outcome>Procedure complication. Timepoint: Begining of procedure until 30 min after that. Method of measurement: Hematoma, Bleeding, Ischemia, .</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-11-10</approval_date>
        <contact_name>Ethics committee of research, Tehran University of Medical Sciences</contact_name>
        <contact_address>6th floor, Central building, Qods Avenue, Keshavarz blvd Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
