<?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>IRCT20230827059269N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-24</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of injectable Acetaminophen with Ketamine injected on reducing acute pain after surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of injectable Acetaminophen with Ketamine injected by Morphine pump on reducing acute pain after surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72326</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: This is a double-blind type of experiment, which will be blind for the people participating in the study and evaluating the outcome. In the consent form to participate in the study, it is written for the patient that his presence does not necessarily mean intervention but may be included in the control group.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute pain after surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In test group A (Acetaminophen drug), after surgery, the patient enters the recovery department, and after fully regaining consciousness and expressing pain, the injection drug Acetaminophen with a dose of 1 mg by an infusion pump by an anesthesiologist as a pain reliever. Analgesic plus 10 mg of Morphine in 100 cc of Normal saline is injected intravenously to the patient at a rate of 4 drops per minute to reduce pain. Intervention 2: Intervention group: In test group B (Ketamine drug), after surgery, the patient enters the recovery department, and after fully regaining consciousness and expressing pain, the injection drug Ketamine with a dose of 1 mg by an infusion pump by an anesthesiologist as a pain reliever. Analgesic plus 10 mg of Morphine in 100 cc of Normal saline is injected intravenously to the patient at a rate of 4 drops per minute to reduce pain. Intervention 3: Control group: In the placebo group, after the surgery, the patient enters the recovery department, and after regaining consciousness and expressing pain, 10 mg of Morphine in 100 cc of Normal saline is injected intravenously at a rate of 4 drops per minute to reduce pain.</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 Satisfaction of participants</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Golrezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar street</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>34197-58911</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>m.golrezaei@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Golrezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar street</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>34197-58911</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>m.golrezaei@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 15 to 60 are candidates for surgery</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of surgery
History of smoking, alcohol and drug abuse
Chronic mental and physical illness (schizophrenia, diabetes, etc.)
Vision and hearing problems and other disabilities
Long-term use of corticosteroids, antihistamines, narcotics and painkillers
Allergy to acetaminophen, ketamine, morphine
Pregnancy and breastfeeding and abortion less than 3 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pain</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: In test group A (Acetaminophen drug), after surgery, the patient enters the recovery department, and after fully regaining consciousness and expressing pain, the injection drug Acetaminophen with a dose of 1 mg by an infusion pump by an anesthesiologist as a pain reliever. Analgesic plus 10 mg of Morphine in 100 cc of Normal saline is injected intravenously to the patient at a rate of 4 drops per minute to reduce pain.</i_keyword>
      <i_keyword>Intervention group: In test group B (Ketamine drug), after surgery, the patient enters the recovery department, and after fully regaining consciousness and expressing pain, the injection drug Ketamine with a dose of 1 mg by an infusion pump by an anesthesiologist as a pain reliever. Analgesic plus 10 mg of Morphine in 100 cc of Normal saline is injected intravenously to the patient at a rate of 4 drops per minute to reduce pain.</i_keyword>
      <i_keyword>Control group: In the placebo group, after the surgery, the patient enters the recovery department, and after regaining consciousness and expressing pain, 10 mg of Morphine in 100 cc of Normal saline is injected intravenously at a rate of 4 drops per minute to reduce pain.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of pain after the operation. Timepoint: 3, 6 and 12 hours after the operation. Method of measurement: Using a ruler-like grading system (Visual Analog Scale) from 0 (no pain) to 10 (the most severe pain imaginable).</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-15</approval_date>
        <contact_name>Ethics committee of qazvin University of Medical Sciences</contact_name>
        <contact_address>Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd,Qazvin Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
