<?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>IRCT201106146804N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-12-17</date_registration>
      <primary_sponsor>Vice Chancellor for research , Baghyatallah Medical Sciences University.</primary_sponsor>
      <public_title>Assessment of efficacy and complication of morphine and naloxan in renal colic</public_title>
      <acronym></acronym>
      <scientific_title>Comparative assessment of analgesic and complications of intravenous morphine and placebo with intravenous naloxon and morphine in renal colic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-12-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7223</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Renal colic.</hc_freetext>
      <i_freetext>Intervention 1: 150 renal colic patients in group B (intervention group), with 18-69 years old age and Pain score, equal or more than 40 or 4 in VAS or NRS system, respectively, will receive 1 CC of low dose naloxone (0.04 mg) intravenously in similar syringes. 5 minutes later,this group will receive 2.5 mg morphine sulfate intravenously. Then we will fallow the patients according to their pain score and complications every 15 minutes for about 90 min. If the pain score does not diminish below 4, we will administer other doses of morphine (max dose: 10 milligram). If despite the Morphine administration (max dose: 10 mg), pain score remains more than the mentioned threshold, the patient will exclude from the study but his pain management will continue. Intervention 2: 150 renal colic patients in Group A (control group); with 18-69 years old age and Pain score, equal or more than 40 or 4 in VAS or NRS system, respectively, will receive 1 cc saline as placebo intravenously. 5 minutes later,this group will receive 2.5 mg morphine sulfate intravenously. Then we will fallow the patients according to their pain score and complications every 15 minutes for about 90 min. If the pain score does not diminish below 4, we will administer other doses of morphine (max dose: 10 milligram). If despite the Morphine administration (max dose: 10 mg), pain score remains more than the mentioned threshold, the patient will exclude from the study but his pain management will continue.</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 Mohammad Javad Behzadnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency  department, Baghyatallah Hospital, Nosrati Alley, Sheikh Bahaie St, Molla Sadra St, Vanaq sq., Tehran,  Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2277 4528</telephone>
        <email>Behzadnia@bmsu.ac.ir</email>
        <affiliation>Baghyatallah Medical Sciences University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohammad Javad Behzadnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency  department, Baghyatallah Hospital, Nosrati Alley, Sheikh Bahaie St, Molla Sadra St, Vanaq sq., Tehran, Iran .</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2277 4528</telephone>
        <email>behzadnia@bmsu.ac.ir</email>
        <affiliation>Baghyatallah medical sciences university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria include : age 18-69 years old; Pain score  equal or more than 40 or 4 in VAS or NRS system, respectively; and Exclusion criteria include: Pyelonephritis or fever equal or more than 38 degree centigrade; History of addiction or opioid allergy;History of cardiovascular disease (function class 3-4 or decompensated CHF or uncontrolled hypertension) ; History of active hepatobiliary disorders ; Hemodinamically unstable patients (BP below 90mmHg or MAP decreased  more than 30% baseline) ;Pregnancy and Breast feeding and History of CVA in last 2 years.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>69 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>150 renal colic patients in group B (intervention group), with 18-69 years old age and Pain score, equal or more than 40 or 4 in VAS or NRS system, respectively, will receive 1 CC of low dose naloxone (0.04 mg) intravenously in similar syringes. 5 minutes later,this group will receive 2.5 mg morphine sulfate intravenously. Then we will fallow the patients according to their pain score and complications every 15 minutes for about 90 min. If the pain score does not diminish below 4, we will administer other doses of morphine (max dose: 10 milligram). If despite the Morphine administration (max dose: 10 mg), pain score remains more than the mentioned threshold, the patient will exclude from the study but his pain management will continue.</i_keyword>
      <i_keyword>150 renal colic patients in Group A (control group); with 18-69 years old age and Pain score, equal or more than 40 or 4 in VAS or NRS system, respectively, will receive 1 cc saline as placebo intravenously. 5 minutes later,this group will receive 2.5 mg morphine sulfate intravenously. Then we will fallow the patients according to their pain score and complications every 15 minutes for about 90 min. If the pain score does not diminish below 4, we will administer other doses of morphine (max dose: 10 milligram). If despite the Morphine administration (max dose: 10 mg), pain score remains more than the mentioned threshold, the patient will exclude from the study but his pain management will continue.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain severity. Timepoint: Every 15 min during 90 min. Method of measurement: Questionaire,according to VAS or NRS pain score systems.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects. Timepoint: Every 15 min during 90 min. Method of measurement: Questionaire,according to physical examination and patients 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 , Baghyatallah Medical Sciences University.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-12-01</approval_date>
        <contact_name>Baghyatallah medical sciences university ethics committee</contact_name>
        <contact_address>3rd floor, Central department, Baghyatallah Medical Sciences University, Vice Chancellor for research,  Nosrati alley, Sheikh Bahaie Molla St, Sadra St, Vanaq sq, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
