<?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>IRCT20211023052851N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-19</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of ketamine in improving renal colic pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparision of the efficacy of IV ketamine with IV morphine and IV ketorolac in patients with renal colic</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59577</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The patient will only be told that we will prescribe painkillers, but only the participant will be unaware of the medication received.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Renal colic.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients with renal colic pain who received intravenous ketamine. In this group of patients, 10% ketamine is slowly injected intravenously and the dosage is equivalent to 0.5 mg / kg body weight. This injection is given only once and its therapeutic effects are evaluated 6 hours after the injection. this drug is made by ROTEXMEDICA Pharmaceutical company. Intervention 2: Control group: Patients with renal colic who received intravenous morphine. Patients in this group receive 3 mg of diluted 1% morphine intravenously and slowly. This injection is given only once and the results are evaluated up to 6 hours after the injection. this drug is made by ROTEXMEDICA Pharmaceutical company. Intervention 3: Control group: Patients with renal colic pain who received intravenous ketorolac. In this group of patients, one  30 mg Ketrolac ampule, equivalent to one ml is injected intravenously. This injection is given only once and Results are evaluated 2 hours after injection. This drug is produced by Raha Pharmaceutical Company.</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:
Data on pain in renal colic patients after ketamine administration after patients were not identified
Data on pain in renal colic patients after morphine administration after patients were not identified
Data on pain in renal colic patients after administration of ketrolac after patients are not identified

When:
Access to data 6 months after the publication of the article

To whom:
Researchers workers in medical academic institutions

Conditions:
Allow access to compare with other painkillers as well as scale with pain relief in other diseases

Where to obtain:
to this email adress:
l32fereshteh@gmail.com

How to obtain:
The data will be reviewed and submitted within one business week upon request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohamad Reza Maghsoodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madani hospital, Jahanshahr blvd.</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411953473</zip>
        <telephone>+98 21 8833 1084</telephone>
        <email>dr.maghsoudi.m@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad Reza Maghsoodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madani hospital, Jahanshahr blvd.</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411953473</zip>
        <telephone>+98 21 8833 1084</telephone>
        <email>dr.maghsoudi.m@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with renal colic pain</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking opium drugs in past 6 hours
History of bipolar and psychological disease</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients with renal colic pain who received intravenous ketamine. In this group of patients, 10% ketamine is slowly injected intravenously and the dosage is equivalent to 0.5 mg / kg body weight. This injection is given only once and its therapeutic effects are evaluated 6 hours after the injection. this drug is made by ROTEXMEDICA Pharmaceutical company.</i_keyword>
      <i_keyword>Control group: Patients with renal colic who received intravenous morphine. Patients in this group receive 3 mg of diluted 1% morphine intravenously and slowly. This injection is given only once and the results are evaluated up to 6 hours after the injection. this drug is made by ROTEXMEDICA Pharmaceutical company.</i_keyword>
      <i_keyword>Control group: Patients with renal colic pain who received intravenous ketorolac. In this group of patients, one  30 mg Ketrolac ampule, equivalent to one ml is injected intravenously. This injection is given only once and Results are evaluated 2 hours after injection. This drug is produced by Raha Pharmaceutical Company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The rate of patient pain reduction. Timepoint: Will assess the severity of pain and side effects at 5, 15, 30 and 60 minutes after drug administration. Method of measurement: The patient is asked to give a score of 10 for the most severe pain he or she has ever experienced, and to rate his or her current pain accordingly.</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>Deputy of Research of Karaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-06</approval_date>
        <contact_name>Ethics committee of Alborz University of Medical Science</contact_name>
        <contact_address>Office of the Ethics Committee-Second Floor-Deputy of Research and Technology-Saffarian Alley-45 meters from Golshahr Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
