<?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>IRCT20140615018091N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-10</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>the preemptive effect of Dexmedetomidine and ketorolac on post operative pain of appendectomy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the preemptive effect of Dexmedetomidine and ketorolac on post operative pain of appendectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34675</url>
      <study_type>observational</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Blinding description: The pump syringes were prepared by an expert in the anesthetic room and the assistant did not know its content.</study_design>
      <phase>1-2</phase>
      <hc_freetext>post operative pain of appendectomy.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group received intravenous dexmedetomidine( Precedex (dexmedetomidine hydrochloride) Hospira, Inc. Lake Forest, IL 60045 USA) 1 μg / kg as bolus dose within 10 minutes immediately before induction and then 5 /. Micrograms per kilogram received continuous infusion during surgery. Intervention 2: Intervention group2: Group B received intravenous 30 mg ketorolac before induction. Intervention 3: Control group: . Group C was the control group that received normal saline, before induction.</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:
spss

When:
1/1/2018

To whom:
Researchers and referees

Conditions:
Obtaining a written permit and mentioning the name in the sources

Where to obtain:
fereydoon fekrat
fereydoonfekrat@yahoo.com

How to obtain:
Email your request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fereydoon Fekrat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Republic Blvd ,  Department of Anesthesiology , Shahid Mohammadi Hospital , Bandar Abbas Town , Islamic Republic of Iran</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919915519</zip>
        <telephone>+98 76 3334 5009</telephone>
        <email>fereydoonfekrat@yahoo.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hashem Jarineshin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Republic Blvd ,  Department of Anesthesiology , Shahid Mohammadi Hospital , Bandar Abbas Town , Islamic Republic of Iran</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919915519</zip>
        <telephone>+98 76 3334 5009</telephone>
        <email>hjarineshin@yahoo.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Appendicitis patients with ASA classification 1 &amp; 2
18-65 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of allergy to any of the drugs used in the study
Patient with ASA classification above two
Addicted patients
Neuropathy or misuse of pain medication
Treatment with analgesics or anti-inflammatory drugs
Pregnancy and lactation
Patients with complicated appendectomy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group received intravenous dexmedetomidine( Precedex (dexmedetomidine hydrochloride) Hospira, Inc. Lake Forest, IL 60045 USA) 1 μg / kg as bolus dose within 10 minutes immediately before induction and then 5 /. Micrograms per kilogram received continuous infusion during surgery.</i_keyword>
      <i_keyword>Intervention group2: Group B received intravenous 30 mg ketorolac before induction</i_keyword>
      <i_keyword>Control group: . Group C was the control group that received normal saline, before induction.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vas score. Timepoint: at 1, 3, 6, 12 and 24 hours after operation. Method of measurement: Visual Analogue Scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>PCA use. Timepoint: at  24 hours after operation. Method of measurement: ml.</sec_outcome>
      <sec_outcome>Age. Timepoint: Before entering the study. Method of measurement: ID card.</sec_outcome>
      <sec_outcome>Weight. Timepoint: After entering the study and obtaining consent. Method of measurement: kg.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: before intubation, immediately after intubation, at 5, 10, 15, 20, 30, 40 and every 10 minutes till the end of operation. Method of measurement: monitoring - mmHg.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: before intubation, immediately after intubation, at 5, 10, 15, 20, 30, 40 and every 10 minutes till the end of operation. Method of measurement: monitoring - Number per minute.</sec_outcome>
      <sec_outcome>Body temperature. Timepoint: before intubation, immediately after intubation, at 5, 10, 15, 20, 30, 40 and every 10 minutes till the end of operation. Method of measurement: Thermometer - C.</sec_outcome>
      <sec_outcome>SpO2. Timepoint: before intubation, immediately after intubation, at 5, 10, 15, 20, 30, 40 and every 10 minutes till the end of operation. Method of measurement: Pulse Oxymetry.</sec_outcome>
      <sec_outcome>Nausea – vomiting. Timepoint: In recovery and 24 hours after surgery. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Shivering. Timepoint: In recovery and 24 hours after surgery. Method of measurement: questionnaire.</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>Bandare-abbas University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-29</approval_date>
        <contact_name>Ethics Committee of Bandar Abbas University of Medical Sciences</contact_name>
        <contact_address>Anesthesiology Research Center, Shahid Mohammadi Hospital, Islamic Republic Blvd. Bandarabbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
