<?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>IRCT201009054697N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-12-07</date_registration>
      <primary_sponsor>School of Dentistry, Islamic Azad University Khorasgan Branch</primary_sponsor>
      <public_title>Effect of Ketamine on Postendodontic Pain</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Preoperative Oral Ketamine in Comparison with Ibuprofen on Postoperative Endodontic Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>51</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5028</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>3</phase>
      <hc_freetext>Postoperative Endodontic Pain.</hc_freetext>
      <i_freetext>Intervention 1: Oral suspension of ibuprofen, 600 mg, A single dose, 30 minutes before the initiation of treatment, Oral. Intervention 2: Placebo, A single dose, 30 minutes before the initiation of treatment, Oral. Intervention 3: Ketamine hydrochloride, 0.5mg/kg, A single dose, 30 minutes before the initiation of treatment, Oral.</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>Ashkan Vakilzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjerib Avenue, Isfahan   and   University Blvd, Arqavanieh, Jey Street, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2621 4610</telephone>
        <email>ashkanvakilzadeh@gmail.com</email>
        <affiliation>School of Dentistry, Isfahan University of Medical Sciences   and   School of Dentistry, Islamic Aza</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ashkan Vakilzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjerib Avenue, Isfahan   and   University Blvd, Arqavanieh, Jey Street, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2621 4610</telephone>
        <email>ashkanvakilzadeh@gmail.com</email>
        <affiliation>School of Dentistry, Isfahan University of Medical Sciences   and   School of Dentistry, Islamic Aza</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1. Patient elects root canal therapy for pain originating from a first or second mandibular molar. 2. The diagnosis of irreversible pulpitis is confirmed by a chief complaint of spontaneous pain and cold test application causing an elevated and lingering pain response. 3. The patient presented with American Society of Anesthesiologists (ASA) I or II medical history. 4. Patient reads and understands questionnaires. 5. Patient reports spontaneous pain above 3cm on a VAS (0-10 cm) in past 24h. 6. Patient provides informed consent. &#13;
Exclusion criteria: 1. Younger than 18 yr or older than 65 yr. 2. Analgesic taken within the last 8h. 3. History of allergy to NSAIDs, ketamine or local anesthetics. 4. Current use of drugs contraindicated with NSAIDs or ketamine. 5. History of gastrointestinal (GI) disorders, renal or hepatic disease, hemorrhagic disorders, active asthma, poorly controlled diabetes mellitus, cardiovascular disease, increased ICP, intracranial mass lesions, ophthalmologic disorder or psychiatric disease. 6. The patient is pregnant or nursing. 7. Periradicular pathosis, other than a widened periodontal ligament. 8. No vital coronal pulp tissue on access. 9. Occurrence of any mistake during root canal therapy.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K08.8, K04</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified disorders of teeth and supporting structures - Toothache NOS   and   Pulpitis: acute</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Oral suspension of ibuprofen, 600 mg, A single dose, 30 minutes before the initiation of treatment, Oral</i_keyword>
      <i_keyword>Placebo, A single dose, 30 minutes before the initiation of treatment, Oral</i_keyword>
      <i_keyword>Ketamine hydrochloride, 0.5mg/kg, A single dose, 30 minutes before the initiation of treatment, Oral</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Before and at 2, 4, 8, 12 and 24h after treatment. Method of measurement: Visual Analog Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The need for additional medication. Timepoint: Until 24h after treatment. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Time to first request for rescue analgesic. Timepoint: Until 24h after treatment. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>The number of rescue analgesic tablets taken. Timepoint: Until 24h after treatment. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>The incidence of side effects. Timepoint: Until 24h after treatment. 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>School of Dentistry, Islamic Azad University Khorasgan Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2007-10-24</approval_date>
        <contact_name>School of Dentistry, Islamic Azad University Khorasgan Branch</contact_name>
        <contact_address>University Blvd, Arqavanieh, Jey Street, Isfahan Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
