<?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>IRCT2017012922697N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-01</date_registration>
      <primary_sponsor>Vice chancellor for research Mashhad university of medical sciences</primary_sponsor>
      <public_title>the evaluation of Clonidine versus Ondansetron for control of pain, nausea &amp; vomiting after Orthognathic surgery.</public_title>
      <acronym>Clonidine versus Ondansetron in Orthognathic surgery.</acronym>
      <scientific_title>The evaluation of pre-operative Clonidine versus Ondansetron prescription for control of pain, nausea &amp; vomiting after Orthognathic surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19523</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: As the effectiveness of clonidine or ondansetron in comparison with placebo for pain and PONV in surgical field is proved in other clinical trial studies; we decided to not have placebo in this study.&#13;
ّFurthermore, the surgeon and anesthesiologist were aware of the drug types in order to prevent the peri and post operative complications; but the student who will record data and analyzing committee of information was blind. the patients were aware of the study interventions because of consent letter. &#13;
Simple randomization ( Random number table) will be used in this study.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: pain after orthosurgery. Condition 2: nausea and vomiting after orthosurgery. Condition 3: Jaw deformity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1:Prescription of ondansetron (8 mg) (150 µg) in form of oral tablets that have been dissolved in 20 ml of water (as intervention) one hour before general anesthesia of orthosurgery. Intervention 2: Intervention 2:Prescription of clonidine (150 µg) in form of oral tablets that have been dissolved in 20 ml of water (as intervention) one hour before general anesthesia of orthosurgery.</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 Majid Eshghpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad dental school, Vakilabad boulvard</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3882 9501</telephone>
        <email>eshghpourm@mums.ac.ir</email>
        <affiliation>oral and maxillofacial surgery department ,Mashhad dental school</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sahand samiee rad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad dental school, Vakilabad boulvard</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3882 9501</telephone>
        <email>samieerads@mums.ac.ir</email>
        <affiliation>oral and maxillofacial surgery department,mashhad dental school</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
All adult patients with ASA class I, II, age range between 18 and 40 years and BMI less than 30 kg per square meter, with jaw deformity and applicable for orthosurgery that referred to Mashhad dental school.&#13;
&#13;
Exclusion criteria:&#13;
	Patients with ASA III class and more.&#13;
	Patients with history of nausea in moving vehicles (Motion sickness)&#13;
	Patients who had experience of previous Ponv, nausea and vomiting in last 24 hours&#13;
	Patients with upper gastrointestinal disorders such as peptic ulcer disease, re flux, pyloric stenosis&#13;
	Patients with history of drug abuse and addiction&#13;
	Patients known to be sensitive to clonidine and ondansetron&#13;
	Patients with history of low blood pressure and bradycardia&#13;
	Patients who need to be care in ICU after surgery.&#13;
	Patients who not wish to continue participation in the program, for any reason.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.5</hc_code>
      <hc_code>F50.5</hc_code>
      <hc_code>K07.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain in joint</hc_keyword>
      <hc_keyword>Vomiting associated with other psychological disturbances</hc_keyword>
      <hc_keyword>Dentofacial anomaly, unspecified</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 1:Prescription of ondansetron (8 mg) (150 µg) in form of oral tablets that have been dissolved in 20 ml of water (as intervention) one hour before general anesthesia of orthosurgery</i_keyword>
      <i_keyword>Intervention 2:Prescription of clonidine (150 µg) in form of oral tablets that have been dissolved in 20 ml of water (as intervention) one hour before general anesthesia of orthosurgery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amount of pain. Timepoint: 1,3,6,12,24 hours after surgery. Method of measurement: VAS.</prim_outcome>
      <prim_outcome>Nausea and vomiting amount after surgery. Timepoint: 1,3,6,12,24 hours after surgery. Method of measurement: yes or no / dose of rescue anti emetic drug.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bradycardia. Timepoint: 1,3,6,12,24 hours after surgery. Method of measurement: clinical observation.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: 1,3,6,12,24 hours after surgery. Method of measurement: clinical observation.</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 Mashhad university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-18</approval_date>
        <contact_name>Ethics committee of Mashhad dental school of Mashhad university of medical sciences,</contact_name>
        <contact_address>Ghoreishi building, Daneshghah avenue Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
