<?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>IRCT20190318043088N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-22</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect diphenhydramine with injectable lidocaine in median nerve block</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of diphenhydramine with injectable lidocaine in median nerve block in patients coming to Imam Khomeini emergency department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>204</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38927</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Selection of the sample is based on the method of the random block. Thus, the first group, A, the second group, B and the third group,  C are considered based on the blocks designed and the following 25 blocks 6 randomly selected from the blocks below, all patients from the number 1 Up to 204 are coded according to one of three words A, B or C. The coding is done randomly by the supervisor of the design, and the project manager, the patient and the analyst of the results of the codes do not know anything about codes.
ABABCC/AABCBC/ABBCAC/AACBCB/CCAABB/CCBBAA/CABACB/BBAACC/CBCBAA/ABCABCCABCAB/BBCCAA/ACBACB/CABCAB/BBCACA/CAABBC/CABCBA/ACBBCA/BACBAC /AABBCC, Blinding description: In this study, the researcher, manager, nurses and the data analyzer are kept blindness. Totally there are three groups. The first group will receive lidocaine 1%, the second group receive diphenhydramine 1% and the third group will receive diphenhydramin 0.5%. The method of blinding is triple blinding. The researcher inject medicine blindly. The medications will be prepared by the supervisor of project and taken to similar syringes and given to the assistant with A, B and C.</study_design>
      <phase>3</phase>
      <hc_freetext>Hand laceration.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Those who receive lidocaine 1%, 3 milliliter, one time, injection, manufacturing factory Caspian. Intervention 2: The first intervention group: Those who receive diphenhydramine 1%. , 3 milliliter, one time, injection, manufacturing factory Caspian. Intervention 3: The second intervention group: Those who receive diphenhydramine 0.5%. , 3 milliliter, one time, injection, manufacturing factory Caspian.</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:
The total individual data of the participants will be shared after being unidentifiable.

When:
Six months after publishing results

To whom:
Doctors, dentists and researchers working in universities and academic institutes

Conditions:
If someone wants to do a research related to this study, he or she can use documentation with the ethical requirements

Where to obtain:
Applicants can receive documentation from the author of the article through this email: faribayazdan@yahoo.com

How to obtain:
Applicants should refer to emergency department of Imam Khomeini hospital with identification card. And after confirmation, they can apply in writing. Then documentation will send them through email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fariba Yazdanbakhsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doctor Gharib Ave., The end of Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6656 1838</telephone>
        <email>faribayazdan@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Yazdanbakhsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doctor Gharib Ave., The end of Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6656 1838</telephone>
        <email>faribayazdan@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patients coming to the emergency with hand laceration from 16 to 65 years</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patients under the age of 16 and over 65
People who are allergic to diphenhydramine or lidocaine or they had conractagonism for lidocaine or diphenhydramine
Patients who had received any systemic pain killer
patients who had received MAO inhibitor</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S64.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injury of median nerve at wrist and hand level</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Those who receive lidocaine 1%, 3 milliliter, one time, injection, manufacturing factory Caspian</i_keyword>
      <i_keyword>The first intervention group: Those who receive diphenhydramine 1%. , 3 milliliter, one time, injection, manufacturing factory Caspian</i_keyword>
      <i_keyword>The second intervention group: Those who receive diphenhydramine 0.5%. , 3 milliliter, one time, injection, manufacturing factory Caspian</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>ِDuration of medicine effect. Timepoint: After the injection of the medicine when the anesthetic begins until the anesthetic ends. Method of measurement: Chronometer.</prim_outcome>
      <prim_outcome>Onset of action of medicine. Timepoint: Immediately after the injection of the medicine. Method of measurement: Chronometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects of medicine. Timepoint: After injection. Method of measurement: Patient Clinic and Previous Studies.</sec_outcome>
      <sec_outcome>The amount of pain. Timepoint: While injecting medicine. Method of measurement: Visual analog scale.</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>2018-07-22</approval_date>
        <contact_name>Ethics committee of Imam Khomeini hospital complex, Tehran university of Medical Sciences</contact_name>
        <contact_address>Doctor Gharib Av., the end of Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
