<?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>IRCT20180717040509N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-27</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of pre-emptive metoclopramide and ondansetron on patients' pain, discomfort and nausea</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of pre-emptive metoclopramide and ondansetron on patients' pain, discomfort and nausea associated with NG Tube insertion</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43465</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with Independent samples. The 46 sample units were divided into two independent groups with equal volume according to the random number table. Random Unit: individual; random tool: Random Number Table, Blinding description: Participants, physicians, nurses, and patient evaluators are not aware of the group allocation.</study_design>
      <phase>3</phase>
      <hc_freetext>Pain, nausea and discomfort from nasal-gastric tube insertion.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: for the intervention group 15 minutes before NG tube placement, 10 mg Ondansetron (manufactured by Alawi Pharmaceutical Company)  injected intravenously. Intervention 2: Intervention group 2: for the intervention group 15 minutes before NG tube placement, 10 mg Metoclopramide (manufactured by Alawi Pharmaceutical Company) injected intravenously. Intervention 3: Control group: patients in the control group received 10 mg of normal saline (as placebo) 15minutes before NG tube placement.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Mohammad Hoseininejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir Mazandarani Street</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816633131</zip>
        <telephone>+98 11 3336 1700</telephone>
        <email>drhoseininejad@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Mohammad Hoseininejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir Mazandarani Street</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816633131</zip>
        <telephone>+98 11 3336 1700</telephone>
        <email>drhoseininejad@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with NG tube Indication</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age less than 18 years old
Lack of consciousness
Patients with unstable hemodynamic status (systolic blood pressure less than 90 mmHg)
Having a nose bleed
Anatomical problems in the nose
Traumatic patients
Sensitivity to Metoclopramide and Ondansetron
Use of Metoclopramide and Ondansetron  interfering drugs
Pregnancy
Patients with nausea and vomiting problem
NG tube more than twice</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: for the intervention group 15 minutes before NG tube placement, 10 mg Ondansetron (manufactured by Alawi Pharmaceutical Company)  injected intravenously.</i_keyword>
      <i_keyword>Intervention group 2: for the intervention group 15 minutes before NG tube placement, 10 mg Metoclopramide (manufactured by Alawi Pharmaceutical Company) injected intravenously.</i_keyword>
      <i_keyword>Control group: patients in the control group received 10 mg of normal saline (as placebo) 15minutes before NG tube placement.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Immediately, 30 and 60 minutes after NG tube insertion. Method of measurement: Visual Analgesic Score.</prim_outcome>
      <prim_outcome>Nausea. Timepoint: Immediately, 30 and 60 minutes after NG tube insertion. Method of measurement: Visual Analgesic Score.</prim_outcome>
      <prim_outcome>Discomfort. Timepoint: Immediately, 30 and 60 minutes after NG tube insertion. Method of measurement: Visual Analgesic Score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bleeding after NG tube insertion. Timepoint: Immediately, 30 and 60 minutes after NG tube placement. Method of measurement: Visual Analgesic Score.</sec_outcome>
      <sec_outcome>Vomiting after NG tube insertion. Timepoint: Immediately, 30 and 60 minutes after NG tube placement. Method of measurement: Visual Analgesic Score.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-02</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Moallem Ave, Moallem Square, Deputy of Research and Technology of Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
