<?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>IRCT20220201053906N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-05</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of Ketamine by nebulizer in reducing pain caused by renal colic.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the analgesic effect of nebulized  Ketamine versus intravenous Ketorolac in reducing pain of  patients with renal colic  who refer to emergency department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62884</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patient will be randomly divided into 2 groups of 54, using random allocation software. Treatments will start randomly from the first patient who has inclusion criteria. First, the numbers 1 to 108 will be written on 108 envelopes. There is a sheet containing the code of each patient's treatment  in each envelope, which is defined by the random allocation software that determines the treatment of each patient. Every patient with inclusion criteria will be allocated an envelope, Blinding description: This study is double-blinded. To blind the patient, the  pain assessor and statistical analyzer a code will be allocated  for each patient. Just emergency medicine specialist and nurse know the meaning of the cods. To make the patient blind, Ketorolac syringe and a placebo nebulizer or Ketamine nebulizer and a placebo syringe will be prepared.
After collecting the data, the data will be entered into SPSS using random allocation software codes and will be provided to the statistical analyzer for analysis.
Pain is a mental variable, therefore, making the pain assessor blind is important. So, the pain assessor who assesses the intensity of pain doesn't know the codes of each treatment, just knows the treatment code of each patient.</study_design>
      <phase>3</phase>
      <hc_freetext>Renal colic.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The nurse nebulizes 0.5 mg/kg Ketamine and injects  1 cc / kg normal saline For the patient who is a member of the intervention group. Intervention 2: Control group: The nurse injects 1mg/kg of Ketorolac  and 0.5 cc / kg of distilled water is nebulizes for the patient in the control group.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more dada</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yasaman Safari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Narges dirmitory, Shahid Fakori Blvd.</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3616911151</zip>
        <telephone>0098 21 2231020</telephone>
        <email>asemon.violet@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hosein Amiri largani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency department, Imam Hosein hospital, Imam Hosein Sq.</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3616951835</zip>
        <telephone>+98 23 3234 2000</telephone>
        <email>amirilargani@shmu.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients 20-70 years old
With acute pain in one side flank
Has informed consent</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unstable patients ( SBP&lt;90, HR&gt;100 or HR&lt;60, fever)
Pregnant or Suspicion of pregnancy
Single kidney
Hasn't informed consent or  unable to have informed consent
Want to discharge before ending the study(2 hours after starting the study)
History of addiction
History of take analgesic at least 6 hours
Symptom or sign of acute abdominal (tenderness, guarding, rebound)
Need Rescue dose before ending of the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N23</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified renal colic</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: The nurse nebulizes 0.5 mg/kg Ketamine and injects  1 cc / kg normal saline For the patient who is a member of the intervention group.</i_keyword>
      <i_keyword>Control group: The nurse injects 1mg/kg of Ketorolac  and 0.5 cc / kg of distilled water is nebulizes for the patient in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of renal colic pain in NRS. Timepoint: Before starting the study, 5, 15, 30 and 60 minutes after starting the study. Method of measurement: Numeric rating scale (NRS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient satisfaction with pain control. Timepoint: 2 hours after the start of the study. Method of measurement: Asking verbal.</sec_outcome>
      <sec_outcome>Side effects of the treatments. Timepoint: Before starting the study, 5, 15, 30, 60 minutes after starting the study and if the patient has been in the hospital for more than 2 hours;  At the time of discharge of the patient. Method of measurement: Medical history and physical examination.</sec_outcome>
      <sec_outcome>Duration of the patient's presence in the emergency department. Timepoint: At the time of discharge of the patient. Method of measurement: Clock.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-28</approval_date>
        <contact_name>Ethics Committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>No. 2, Sixth Alley, Shahid Rajaee Ave., Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
