<?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>IRCT20190113042346N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-10</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of normal saline cold grass with honey   and normal saline  cold on the pain of children`s tonsillectomy/adenotonsillectomy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of normal saline cold grass with honey   and normal saline  cold on the pain of children`s tonsillectomy/adenotonsillectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37119</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be referred to on a regular basis. Patient allocation will be done in groups of this study using Block Randomization. In this way, by determining the blocks and randomly choosing blocks, the patient number received by the group of three The frequency is determined and then the number of patients in the group according to the requirements of the code is specified and according to the codes, gradually, by referring the patients to the intervention is done. To determine the normal saline (NC) intervention groups, the normal saline group with honey (NH) and normal saline is also characterized by temperature (control group) (N). And patients are given four-digit code, Blinding description: To blind people, patients who do not wake up will not notice that they are in the group's custody, and the pain assessor will not be informed about which group the patient is in.</study_design>
      <phase>3</phase>
      <hc_freetext>Post-operative pain Tansillectomy / Adenotonsillectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervetion groupe: First intervention: In the normal group of saline with honey (NH) at the end of the operation, the pharyngeal cavity and around the tonsils at the end of the operation with normal saline 0.9%, the temperature with the room washed and cleaned and then suctioned, and after the operation, the patient's pain It is recorded in the recovery at the time of discharge and every 6 hours for two days gargle the normal solution of saline 0.9% to 100 cc at a concentration of 10/10 with mixed honey (100 ml of honey mixed per liter of normal saline) The patient is given and after each time gargle the pain is recorded and the pain will be recorded on the first and second day after the sharp operation. Second intervention: In the normal saline group, 4 ° C (NC) was washed and cleaned at the end of the oral cavity and around the tonsil with normal saline 0.9% and then suctioned and recorded in the recovery procedure at the time of discharge. A normal saline solution was placed in the refrigerator and using the thermometer in the refrigerator, the solution temperature would be used when it reached 4 ° C, and every 6 hours the normal solution of saline was 0.9% cold at 4 ° C at 100 cc by the gargoyle patient And the amount of pain after gargoying each time and on the first and second day after the operation will be recorded. Intervention 2: Control group: In the control group (N), the routine routine washing of the pharyngeal cavity and around the tonsils at the end of the surgery will be done, and the pain will be recorded in recovery and every 6 hours on the first and second day after the operation. And there will be no intervention.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
We will record the data obtained after the illness.

When:
Get started 6 months after printing resultsمحققین

To whom:
Researchers and researchers at academic and academic institutions

Conditions:
Using the source and the researchers' satisfaction, this study is applicable

Where to obtain:
Can contact Hosnieh Raufiyan at h.raufyian@gmail.com

How to obtain:
Upon receipt of a request for access to the document, it will be delivered to the maximum of up to two months

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hosnieh Raufiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Toos Boulevard, Toos 65, Najaf 34, Milan 1st to the right, Third door to the right</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9198185477</zip>
        <telephone>+98 51 3657 6830</telephone>
        <email>h.raufyian@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ebrahim Nasiri Formi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sari, Three streams Joyber, Beginning of Valiasr highway, central headquarters of Mazandaran University of Medical Sciences and Health Services</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48157-33971</zip>
        <telephone>+98 11 3304 4000</telephone>
        <email>rezanf2002@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Tonsillectomy / Elective adenotonsillectomy
ASA class one and two
Aged 5-14 years old
Obtaining written consent from the patient</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Need to re-intubate
Bleeding and needing re-operation
Failure to intubate the chip
Bleeding disorders
Systemic diseases like diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R07.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain in throat</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervetion groupe: First intervention: In the normal group of saline with honey (NH) at the end of the operation, the pharyngeal cavity and around the tonsils at the end of the operation with normal saline 0.9%, the temperature with the room washed and cleaned and then suctioned, and after the operation, the patient's pain It is recorded in the recovery at the time of discharge and every 6 hours for two days gargle the normal solution of saline 0.9% to 100 cc at a concentration of 10/10 with mixed honey (100 ml of honey mixed per liter of normal saline) The patient is given and after each time gargle the pain is recorded and the pain will be recorded on the first and second day after the sharp operation. Second intervention: In the normal saline group, 4 ° C (NC) was washed and cleaned at the end of the oral cavity and around the tonsil with normal saline 0.9% and then suctioned and recorded in the recovery procedure at the time of discharge. A normal saline solution was placed in the refrigerator and using the thermometer in the refrigerator, the solution temperature would be used when it reached 4 ° C, and every 6 hours the normal solution of saline was 0.9% cold at 4 ° C at 100 cc by the gargoyle patient And the amount of pain after gargoying each time and on the first and second day after the operation will be recorded.</i_keyword>
      <i_keyword>Control group: In the control group (N), the routine routine washing of the pharyngeal cavity and around the tonsils at the end of the surgery will be done, and the pain will be recorded in recovery and every 6 hours on the first and second day after the operation. And there will be no intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative pain Tonsillectomy / Adenotonsillectomy. Timepoint: When clearance is recovered, and at intervals every 6 hours on the first day, the end of the first day, the end of the second day. Method of measurement: For the assessment of pain, Wang Baker's scale for children will be used for children.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-05</approval_date>
        <contact_name>Deputy of Research and Technology of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Sari, Three streams Joybar, Beginning of Valiasr highway, central headquarters of Mazandaran University of Medical Sciences and Health Services Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
