<?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>IRCT20130304012695N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-26</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Analgesic effect of combining Midazolam, Morphine and Diphenhydramine for acute postoperative pain management, A comparative study</public_title>
      <acronym></acronym>
      <scientific_title>Analgesic effect of combining Midazolam, Morphine and Diphenhydramine for acute postoperative pain management, A comparative study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48238</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling is done by easy burst method and according to patient referral to recovery room.
Randomization method is balanced block randomization and will be done by Randlist software, Blinding description: The person who makes the medicine add a code to every single medicine .
The person who injects the drug does not know the code.
The patient is not aware of the type of injectable medication.
The researcher is not aware of the type of drug during the study.</study_design>
      <phase>3</phase>
      <hc_freetext>postoperative pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Morphine, Midazolam, In this group, in a syringe of 10 cc, 10 mg of morphine, 100 mg of diphenhydramine and 10 mg of midazolam,prepared then  increase the volume to 10 cc with distilled water.In patients who have pain and want to take analgesia, we inject one cc of this medicine mixture. Two minutes after the injection, if the pain is not controlled, we take another cc of this mixture. we record the number of injections and reduce the severity of the pain and the duration of the pain reduction per minute. Intervention 2: Control group: Morphine, ketamine, Diphenhydramine.In this group, in a syringe of 10 cc, 10 mg of morphine, 100 mg of diphenhydramine and 10 mg of ketamine,prepared then  increase the volume to 10 cc with distilled water.In patients who have pain and want to take analgesia, we inject one cc of this medicine mixture. Two minutes after the injection, if the pain is not controlled, we take another cc of this mixture. we record the number of injections and reduce the severity of the pain and the duration of the pain reduction per minute.</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 It is unknown at this time what will be done</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadreza Khajavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1136746911</zip>
        <telephone>+98 21 6312 1220</telephone>
        <email>khajavim@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadreza Khajavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1136746911</zip>
        <telephone>+98 21 6312 1220</telephone>
        <email>khajavim@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients are extubated after surgery and recover. In recovery, patients were evaluated based on VAS or Richmond criteria, and if they had a VAS&gt; 4 score or Richmond +2 and above, they entered the study and were randomly assigned to one of the two groups.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>opioids addiction, underlying ischemic cardiac diseases, renal function and liver function diseases, history of allergic reaction to any of the medications used, and use of any antiemetic and antipsychotic medications, PONV and glaucoma.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S66.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injury of long flexor muscle, fascia and tendon of thumb at wrist and hand level</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>Intervention group: Morphine, Midazolam, In this group, in a syringe of 10 cc, 10 mg of morphine, 100 mg of diphenhydramine and 10 mg of midazolam,prepared then  increase the volume to 10 cc with distilled water.In patients who have pain and want to take analgesia, we inject one cc of this medicine mixture. Two minutes after the injection, if the pain is not controlled, we take another cc of this mixture. we record the number of injections and reduce the severity of the pain and the duration of the pain reduction per minute.</i_keyword>
      <i_keyword>Control group: Morphine, ketamine, Diphenhydramine.In this group, in a syringe of 10 cc, 10 mg of morphine, 100 mg of diphenhydramine and 10 mg of ketamine,prepared then  increase the volume to 10 cc with distilled water.In patients who have pain and want to take analgesia, we inject one cc of this medicine mixture. Two minutes after the injection, if the pain is not controlled, we take another cc of this mixture. we record the number of injections and reduce the severity of the pain and the duration of the pain reduction per minute.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effect of the drug combination of midazolam, diphenhydramine and morphine on pain relief. Timepoint: In 5, 10, 15, 30 minutes after the operation, the severity pain was measured. Method of measurement: visual analog scal.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patients' agitation evaluation. Timepoint: In 5, 10, 15 and 30 minutes after surgery. Method of measurement: richmond agitation scale.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-19</approval_date>
        <contact_name>Ethics committee of ،tehran University of Medical Sciences</contact_name>
        <contact_address>sina hospital, imam khomeini st. tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
