<?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>IRCT2015111825123N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-08</date_registration>
      <primary_sponsor>Vice chancellor for research Shahid Sadoughi University of medical sciences</primary_sponsor>
      <public_title>Effect of hyoscine on severity of pain, tenderness and rebound tenderness in patients candidate for appendectomy</public_title>
      <acronym></acronym>
      <scientific_title>Effect of hyoscine on severity of pain, tenderness and rebound tenderness in patients &#13;
candidate for appendectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21062</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Other design features: This interventional study (before-after) was conducted on 70 patients who were candidates for appendicitis surgery and referred to Shahid Sadoughi and Farokhi hospitals, Yazd, Iran. The patients were selected in a non random manner. No placebo group was considered since there was no expectation to reduce the pain without analgesics. Inclusion criteria of the current study were as follows: taking any psychiatric medicine, lesions on the abdominal surface such as cellulite, scars, taking analgesic drugs before entering the emergency room, hiatal hernia, history of kidney stones, current urinary infection, history of trauma on the area during last 2 weeks, menstrual bleeding, drug addiction. Sensitivity to drug was considered as exclusion criterion. First demographic information such as age and sex was obtained. To establish appendicitis diagnosis of surgery candidates, patients’ rebound tenderness and pain were evaluated usingnumeric rating scale. Then 0.3 mg /kg of hyoscine was administered intravenously. Using the previous method, rebound tenderness and pain were remeasured fifteen minutes later. Regarding the possibility of negative appendectomy or other diagnoses, 70 patients diagnosed with appendicitis by pathologist were underwent further investigation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pain in appendicitis.</hc_freetext>
      <i_freetext>0.3 mg /kg of hyoscine (Matin co- Tehran pharmacology) was administered intravenously. Using the previous method, rebound tenderness and pain were measured fifteen minutes later..</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>vahide salimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sdoughi hospital, Alem Sq, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00</telephone>
        <email>vahideh101052@yahoo.com</email>
        <affiliation>Shahid Sadoughi University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>vahide salimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sdoughi hospital, Alem Sq, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00</telephone>
        <email>vahideh101052@yahoo.com</email>
        <affiliation>Shahid Sadoughi University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>exclusion criteria:&#13;
other medical problems; psychological problems; painful lesion; analgesic using; umbilicall hernia; History of kidney stones; UTI; addiction; trauma during past 2 weeks; reaction to drug&#13;
&#13;
inclusion criteria:15-45 year olds; candidate for appendectomy</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K35-K38</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of appendix</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>0.3 mg /kg of hyoscine (Matin co- Tehran pharmacology) was administered intravenously. Using the previous method, rebound tenderness and pain were measured fifteen minutes later.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before and after hyoscine. Method of measurement: Visual analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Tenderness. Timepoint: before and after hyoscine. Method of measurement: verbal- scorring 1-10.</sec_outcome>
      <sec_outcome>Rebound tenderness. Timepoint: before and after. Method of measurement: verbal- scoring 1-10.</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 Sadoughi University of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-20</approval_date>
        <contact_name>Ethic committee of Shahid Sadoughi university of medical sciences</contact_name>
        <contact_address>Shahid Sadoughi hospital, Alem Sq, Yazd Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
