<?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>IRCT20190208042654N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-12</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of acetaminophen and dexmedetomidine infusion on the severity of cataract surgery pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between the effects of Acetaminophen and Dexmedetomidine infusion and normal saline on pain severity after cataract surgery an open label randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>135</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51203</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This randomized controlled clinical trial had an equal allocation ratio for two groups of the study, Randomization description: The study population was selected on a consecutive basis. For the randomization of the participants, first, the principal investigator used the “Sealedenvelope” website to create blocks containing 9 individuals, containing three participants for each of three groups. Every participant had a unique code consisting of two letters and one number. This generated list remained confidential for participants, clinicians who enrolled the patients in the study, clinicians who injected the drugs and data analyzer. Patients have entered the study groups (A, B and C) according to the generated list, after a full explanation of the study process and obtaining written consent, Blinding description: This study is a single-blind study, where physicians and patients were aware of study groups and only the statistical analyzer was blind for treatment groups. Each group was assigned with A or B or C, which makes the analyzer blind for the treatment group.</study_design>
      <phase>3</phase>
      <hc_freetext>Cataract.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: infusion of Acetaminophen IV at a dose of 15 mg/kg within the first 15 minutes of surgery, slowly in total volume of 100 ml. Intervention 2: Intervention group 2: infusion of dexmedetomidine IV at a dose of 0.5 µgr/kg within the first 15 minutes of surgery, slowly in total volume of 100 ml. Intervention 3: Control group: Injection of 100 ml of normal saline in the first 15 minutes of surgery.</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 Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dariush Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alzahra Hospital, Sofe Blv</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7346181746</zip>
        <telephone>+98 31 3620 1992</telephone>
        <email>dmoradi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dariush Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alzahra Hospital, Sofe Blv</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7346181746</zip>
        <telephone>+98 31 3620 1992</telephone>
        <email>dmoradi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>َI or II physical health score according to the classification of the American Society of Anesthesiologists
Candidate for cataracts surgery
Age between 50 to 80 years old
Patient consent to participate in the study</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patient contraindication of dexmedetomidine or acetaminophen
َAllergies to any of the drugs used in the trial
Blood coagulation problems
Altered mental status
Severe cardiovascular diseases
chronic obstructive pulmonary disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08.36</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition with diabetic cataract</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 1: infusion of Acetaminophen IV at a dose of 15 mg/kg within the first 15 minutes of surgery, slowly in total volume of 100 ml</i_keyword>
      <i_keyword>Intervention group 2: infusion of dexmedetomidine IV at a dose of 0.5 µgr/kg within the first 15 minutes of surgery, slowly in total volume of 100 ml</i_keyword>
      <i_keyword>Control group: Injection of 100 ml of normal saline in the first 15 minutes of surgery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain severity. Timepoint: immediately after surgery, 2 hours, 4 hours, and 6 hours after moving to the recovery room and then at the time of discharge. Method of measurement: Based on Visual Analog Scale (VAS) on a scale from 0 to 10.</prim_outcome>
      <prim_outcome>Surgeon Satisfaction from sedation. Timepoint: After surgery. Method of measurement: Levels of satisfaction were defined as Excellent (The patient's sedation and cooperation were complete), Good (The patient cooperated despite unwanted and minor eye movements) and poor (There was a lot of unwanted eye movement during the operation and the patient did not cooperate).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart Rate. Timepoint: the start of surgery, 5, 10 and 15 minutes after starting of surgery, then at the beginning of recovery, 20, 40, 60 minutes after starting of recovery. Method of measurement: Through patient monitoring device or by taking a carotid pulse.</sec_outcome>
      <sec_outcome>Respiratory rate. Timepoint: the start of surgery, 5, 10 and 15 minutes after starting of surgery, then at the beginning of recovery, 20, 40, 60 minutes after starting of recovery. Method of measurement: Counting the respiratory cycles in one minute.</sec_outcome>
      <sec_outcome>Venous Oxygen Saturation. Timepoint: the start of surgery, 5, 10 and 15 minutes after starting of surgery, then at the beginning of recovery, 20, 40, 60 minutes after starting of recovery. Method of measurement: Pulse oximetry.</sec_outcome>
      <sec_outcome>Systolic Blood Pressure. Timepoint: the start of surgery, 5, 10 and 15 minutes after starting of surgery, then at the beginning of recovery, 20, 40, 60 minutes after starting of recovery. Method of measurement: non-invasive blood pressure (NIBP) monitoring.</sec_outcome>
      <sec_outcome>Diastolic Blood Pressure. Timepoint: the start of surgery, 5, 10 and 15 minutes after starting of surgery, then at the beginning of recovery, 20, 40, 60 minutes after starting of recovery. Method of measurement: non-invasive blood pressure (NIBP) monitoring.</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>2017-06-21</approval_date>
        <contact_name>Ethics committe of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jarib Ave Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
