<?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>IRCT2016072529065N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-08</date_registration>
      <primary_sponsor>Vice chancellor for research of Yasuj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of bupivacaine with lidocain and epinephrine composition on the pain in patients undergoing  tonsillectomy surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effect of local injection of bupivacaine with lidocain and epinephrine composition on post tonsillectomy pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>87</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23448</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Block Randomize Allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Tonsilectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After induction of anesthesia, cold knife tonsillectomy will be performed. 5 minutes before the surgical incision, in the first group 2 mL of 0.125 bupivacaine, in the second group 2 mL of 1% lidocaine and 1:200,000 epinephrine composition, will be injected locally  on the bed and around the tonsils with a single technique as a fan of the upper and lower poles of the tonsils and tonsillectomy will be done. The duration of anesthesia and surgery asses, also patients' vital signs will be recorded before induction of anesthesia, during surgery and in the recovery room. After surgery and transferring the patients of recovery room to the ENT ward, patients' Vital Signs and demographic data collected by check list and pain will be measured 2 hours, 4 hours and 6 hours after surgery with Wong-Baker Pain Scale. Intervention 2: Control group: After induction of anesthesia, cold knife tonsillectomy will be performed. There is no intervention in Group 3. The duration of anesthesia and surgery asses, also patients' Vital Signs will be recorded before induction of anesthesia, during surgery and in the recovery room. After surgery and transferring the patients of recovery room to the ENT ward, patients' Vital Signs and demographic data collected by check list and pain will be measured 2 hours, 4 hours and 6 hours after surgery with Wong-Baker Pain Scale.</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>Mahin Roozitalab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>College Paramedicine, Yasuj University of Medical Sciences, Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 74 3323 5142</telephone>
        <email>mohammadi.b1391@yahoo.com؛ roozitalab95@gmail.com</email>
        <affiliation>Yasuj University of Medical Sciences, Yasuj, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Roozitalab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>paramedicin College, Yasuj University of Medical Sciences, Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 74 3323 5142</telephone>
        <email>mohammadi.b1391@yahoo.com؛ roozitalab95@gmail.com</email>
        <affiliation>Yasuj University of Medical Sciences, Yasuj, IRAN</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patient candidate for elective tonsillectomy; children aged 4 to 10 years; consent of the parents;  lack of co-morbidities; negative history of surgery; The ability to verbal communication; cognitive and Mental health.&#13;
Exclusion criteria: metabolic and endocrine diseases; coagulation disorders; mental retardation; positive history of allergy to drugs; pre-tonsilar abscess; hypertension; psychotic disorder; chronic pain; want to withdraw the study; creates complications in patients like bleeding, Late recovery (2 hours post operation); receiving narcotic drug during study; obesity</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>10 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic diseases of tonsils and adenoids</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>Intervention group: After induction of anesthesia, cold knife tonsillectomy will be performed. 5 minutes before the surgical incision, in the first group 2 mL of 0.125 bupivacaine, in the second group 2 mL of 1% lidocaine and 1:200,000 epinephrine composition, will be injected locally  on the bed and around the tonsils with a single technique as a fan of the upper and lower poles of the tonsils and tonsillectomy will be done. The duration of anesthesia and surgery asses, also patients' vital signs will be recorded before induction of anesthesia, during surgery and in the recovery room. After surgery and transferring the patients of recovery room to the ENT ward, patients' Vital Signs and demographic data collected by check list and pain will be measured 2 hours, 4 hours and 6 hours after surgery with Wong-Baker Pain Scale.</i_keyword>
      <i_keyword>Control group: After induction of anesthesia, cold knife tonsillectomy will be performed. There is no intervention in Group 3. The duration of anesthesia and surgery asses, also patients' Vital Signs will be recorded before induction of anesthesia, during surgery and in the recovery room. After surgery and transferring the patients of recovery room to the ENT ward, patients' Vital Signs and demographic data collected by check list and pain will be measured 2 hours, 4 hours and 6 hours after surgery with Wong-Baker Pain Scale.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 2,4,6 post operation surgery. Method of measurement: wong- baker scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Vital Signs. Timepoint: 2,4,6 Post Operation Surgery. Method of measurement: Sphygmomanometer,Thermometer.</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 of Yasuj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-01-02</approval_date>
        <contact_name>Ethics committe of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj University of Medical Sciences Yasuj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
