<?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>IRCT2012120211637N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-02-05</date_registration>
      <primary_sponsor>Birjand Univercity of Medical Sciences</primary_sponsor>
      <public_title>Effect of antibiotic therapy on recovery after tonsillectomy and adenotonsillectomy complications</public_title>
      <acronym></acronym>
      <scientific_title>Effect of antibiotic therapy on recovery after tonsillectomy and adenotonsillectomy complications</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-11-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>138</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11817</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Tonsillectomy. Condition 2: Adenotonsillectomy.</hc_freetext>
      <i_freetext>Intervention 1: Ampicillin intravenously as a single dose of 75 mg per kg before surgery and  one dose every 6 hours to 24 hours one and for one week amoxiciline capsul 50 mg per kg every 8 hours. Intervention 2: The control group did not receive any antibiotics.</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>Dr Mohammadreza Mofateh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaffari street, Birjand University of Medical Sciences</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 1444 0388</telephone>
        <email>rezamood@bums.ac.ir; yaldajannesar@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Seyed Hasan Golboie Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaffari street- Birjand University of Medical Sciences</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 1444 0388</telephone>
        <email>dr.golboie@yahoo.com; yaldajannesar@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criterion: all patients admitted for tonsillectomy and adenotonsillectomy in ear, nose and throat department Valiasr Hospital, Birjand, Iran.&#13;
   Exclusion critria: fever (oral temperature greater than 38.2); acute larengopharngyt or evidence of systemic infection in the past three weeks; adenoidectomy alone any type of bleeding disorder (pt, ptt abnormal) and throat disorders like laryngeal cleft palate with underlying diseases (heart disease, respiratory ...) or contraindication for general anesthesia, history of Perry tonsilar abscess, serous otitis media (SOME), evidence of active infection at the time of entry, immunodeficiency, and long-term use of corticosteroids.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>28.92</hc_code>
      <hc_code>28.92</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>tonsillectomy</hc_keyword>
      <hc_keyword>Adenectomy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Ampicillin intravenously as a single dose of 75 mg per kg before surgery and  one dose every 6 hours to 24 hours one and for one week amoxiciline capsul 50 mg per kg every 8 hours</i_keyword>
      <i_keyword>The control group did not receive any antibiotics.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative Recovery and complications. Timepoint: from 4 hours after surgery to one  week later. Method of measurement: Nausea and vomiting - oral temperature - bleeding - Time to start drinking fluids - pain -analgesia  needed after tonsillectomy and adenotonsillectomy r.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Oral tempreture. Timepoint: 4 hours after operation-10 hours after operation-1 week after operation. Method of measurement: mercury thermometer.</sec_outcome>
      <sec_outcome>Pain. Timepoint: 4 hours after surgery-7 hours after surgery-10 hours after surgery-1 week after surgery. Method of measurement: pain scale Criterion.</sec_outcome>
      <sec_outcome>Nausea-vommiting. Timepoint: 6 hours after surgery. Method of measurement: Rhodes index.</sec_outcome>
      <sec_outcome>Bleeding. Timepoint: intra operation-24 hours after operation-24 hours later. Method of measurement: a case history.</sec_outcome>
      <sec_outcome>White blood cell count. Timepoint: 24 hours after operation. Method of measurement: CBC.</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>Birjand Univercity of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-11-11</approval_date>
        <contact_name>Birjand Univercity of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Birjand Univercity of Medical Sciences, Ghaffari Street Birjand  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
