<?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>IRCT20180906040960N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-16</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Dexamethasone and Ketrolac on postoperative pain</public_title>
      <acronym></acronym>
      <scientific_title>Effect of submucosal injection of Ketorolac versus Dexamethasone on postoperative pain after third molar surgery: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40406</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization method of this study was simple.
The randomization unit of this study is personal.
Sixty patients who were eligible to participate in the study were assigned a multi-digit random number obtained by using a random number table and then the numbers were placed in a bag.
The numbers were removed from the bag and placed in the Ketorolac, Dexamethasone and control groups, respectively.
These random numbers were also pasted on insulin syringes.
On the day of surgery, the patient receives a pre-filled insulin syringe and gives it to the surgeon to perform the concealment properly, Blinding description: After selecting the patients, the drugs that were already labeled and had a special code were given to the nurse. The nurse took the medicine in a special syringe and gave it to the therapist. Therapists and nurses were unaware of the type of drug because the color and volume of the substances in all three groups were similar. The nurse then recorded the special code on a piece of paper.</study_design>
      <phase>3</phase>
      <hc_freetext>Pain intensity and number of analgesics used by patients after impacted mandibular third molar surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: "group K" received 1ml ketorolac 30 mg. Intervention 2: Intervention group 2: "group D" received 1ml dexamethasone 4mg. Intervention 3: Control group: "Group C" received 1ml normal saline as placebo.</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:
Informed consent - Patient questionnaire and SPSS data

When:
Access started from 2023

To whom:
Consultant Professor and Supervisor

Conditions:
The data can only be used for evaluation and verification

Where to obtain:
Applicants can use the data and information only with the coordination of the tutor

How to obtain:
The required information will be provided to the applicants for one week at their discretion

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dariush Hasheminia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>First corner, Soroush St., Ahmad Abad Sq., Isfahan Town</address>
        <city>esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>817473441</zip>
        <telephone>+98 31 3792 5523</telephone>
        <email>farhad73mardani@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>‪Reyhaneh Faghihian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>First corner, Soroush St., Ahmad Abad Sq., Isfahan Town</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673441</zip>
        <telephone>009837925523</telephone>
        <email>reyhane.fgh@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients must be over 16 years old.
Patients who according to the category ASA are in group 1or 2.
People who have not taken any painkillers a week before surgery.
The patient should not have any infection or pain or other medical problems in the week before surgery.
All the patients have at least one impacted mandibular third molar detected by a panoramic radiograph.
The impacted teeth categorized as class II relationship, position ‘B’ angulation.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient who has not any gastrointestinal diseases.
Impacted tooth has no symptom.
Procedure prolonged more than 30.
The patient is pregnant or breastfeeding.
The patient has a physical or mental disability.
Patient with a history of allergies or contraindications for nonsteroidal anti-inflammatory drugs.
During the study period, the patient develops a complication that interferes with his treatment.
The patient is taking medication due to a disease.</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>Intervention group 1: "group K" received 1ml ketorolac 30 mg</i_keyword>
      <i_keyword>Intervention group 2: "group D" received 1ml dexamethasone 4mg</i_keyword>
      <i_keyword>Control group: "Group C" received 1ml normal saline as placebo.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity in patients in Ketorolac group. Timepoint: Measurement of patients' pain intensity before surgery and after surgery with an interval of one hour until 12 hours after surgery. Method of measurement: VAS.</prim_outcome>
      <prim_outcome>Pain intensity in patients in Dexamethasone group. Timepoint: Measurement of patients' pain intensity before surgery and after surgery with an interval of one hour until 12 hours after surgery. Method of measurement: VAS.</prim_outcome>
      <prim_outcome>Pain intensity of group patients in control. Timepoint: Measurement of patients' pain intensity before surgery and after surgery with an interval of one hour until 12 hours after surgery. Method of measurement: VAS.</prim_outcome>
      <prim_outcome>Number of Analgesics in the Ketorolac group. Timepoint: Immediately after surgery up to 72 hours after surgery. Method of measurement: Number of pills by day.</prim_outcome>
      <prim_outcome>Number of Analgesics in Dexamethasone group. Timepoint: Immediately after surgery up to 72 hours after surgery. Method of measurement: Number of pills by day.</prim_outcome>
      <prim_outcome>Number of analgesics used in the control group. Timepoint: Immediately after surgery up to 72 hours after surgery. Method of measurement: Number of pills by day.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-07</approval_date>
        <contact_name>Vice-chancellor in research affairs-medical university of isfahan</contact_name>
        <contact_address>No.8174673461, Hezar Jerib St., Isfahan University of Medical Sciences, Faculty of Dentistry, Isfahan Town, Iran Isfehan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
