<?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>IRCT20210906052394N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-18</date_registration>
      <primary_sponsor>Scientific Association of Islamic Azad University, Aliabad Katoul Branch</primary_sponsor>
      <public_title>Implementation of pain control instructions on sedation and duration of mechanical ventilation in patients admitted to the intensive care unit</public_title>
      <acronym></acronym>
      <scientific_title>The effect of implementing pain control instructions on sedation and duration of mechanical ventilation in patients admitted to the intensive care unit of Hakim Jorjani Hospital in 2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58561</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Pain Control. Condition 2: Sedation. Condition 3: Mechanical Ventilation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The patient is evaluated every 4 hours according to the Pain Control Instruction. If the patient needs pain relief (pain assessment with Pain Behavioral Scale), morphine 1 to 5 mg is used intravenously and Repeat every 10 minutes if needed. Maximum to 10 milligram per kilogram per hour is used. If the patient is not relieved with this amount of drug, it is evaluated using the Richmond sedation criterion and if necessary, 1 to 4 milligram of midazolam is injected intravenously. Repeat every 15 minutes if needed. Maximum to 10 milligram per houre can be used. At the threshold of separation from the mechanical ventilation device, the patient's sedation is discontinued and if necessary, fentanyl is infused at a dose of 1 micrograms per kilogram per hour. 4 hours after separation from the mechanical ventilator, using the Bern checklist, if a patient scores above 17, we use a single dose of intravenous dexamethasone (0.1 milligram per kilogram). Intervention 2: Control group: "The control group continues to receive sedations as directed by the physician and does not receive any additional medications or placebos.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Amini alley,60 Metri Ave,Emam Ali Blve</address>
        <city>Marvdasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7371753519</zip>
        <telephone>+98 71 4332 2047</telephone>
        <email>Maryam.zareia1369@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Amini alley,60 Metri Ave,Emam Ali Blvd</address>
        <city>Marvdasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7371753519</zip>
        <telephone>+98 71 4332 2047</telephone>
        <email>Maryam.zareia1369@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a endotracheal tube or tracheostomy tube
Need for mechanical ventilation
Inability to communicate verbally
Insensitivity to Morphine and Fentanyl
No kidney disease
Having a systolic blood pressure greater than 100 mm Hg
A score above 3 on the Richmond scale
A score between 5 Up to 13 on the Glasgow scale</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Allergy to Morphine and Fentanyl
Having kidney disease
Score below 3 on the Richmond Scale
Having a systolic blood pressure of less than 100 mm Hg</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The patient is evaluated every 4 hours according to the Pain Control Instruction. If the patient needs pain relief (pain assessment with Pain Behavioral Scale), morphine 1 to 5 mg is used intravenously and Repeat every 10 minutes if needed. Maximum to 10 milligram per kilogram per hour is used. If the patient is not relieved with this amount of drug, it is evaluated using the Richmond sedation criterion and if necessary, 1 to 4 milligram of midazolam is injected intravenously. Repeat every 15 minutes if needed. Maximum to 10 milligram per houre can be used. At the threshold of separation from the mechanical ventilation device, the patient's sedation is discontinued and if necessary, fentanyl is infused at a dose of 1 micrograms per kilogram per hour. 4 hours after separation from the mechanical ventilator, using the Bern checklist, if a patient scores above 17, we use a single dose of intravenous dexamethasone (0.1 milligram per kilogram).</i_keyword>
      <i_keyword>Control group: "The control group continues to receive sedations as directed by the physician and does not receive any additional medications or placebos.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain control. Timepoint: Consecutively every 4 hours after starting the study. Method of measurement: Behavioral tools for measuring pain(BPS).</prim_outcome>
      <prim_outcome>Sedation. Timepoint: Consecutively every 4 hours after starting the study. Method of measurement: Richmond agitation sedation acale.</prim_outcome>
      <prim_outcome>Duration of mechanical ventilation. Timepoint: Consecutively every 4 hours after starting the study. Method of measurement: BURNS' WEAN ASSESSMENT PROGRAM (BWAP).</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>Islamic Azad University, Aliabad Katoul Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-08</approval_date>
        <contact_name>Islamic Azad University, Chalous Branch</contact_name>
        <contact_address>Shahid Amini alley ,60 metri Ave,Emam Ali Blvd Marvdasht Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
