<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03296020</url>
  </required_header>
  <id_info>
    <org_study_id>0079-17-EMC</org_study_id>
    <nct_id>NCT03296020</nct_id>
  </id_info>
  <brief_title>The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study</brief_title>
  <official_title>The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HaEmek Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the effect of honey administration on pain following&#xD;
      pediatric tonsillectomy or adenotonsilectomy.&#xD;
&#xD;
      The patients( children 2-18 years old) will divide into two groups by simple randomization&#xD;
      method( the control group and the case group).&#xD;
&#xD;
      After surgery the case group: would instructed to use honey twice a day( 5 ml- one tea spoon&#xD;
      each time)+acetaminophen syrup+ syrup oxycode( as necessary).&#xD;
&#xD;
      the control group would get as is customary in our ENT department :acetaminophen syrup+ syrup&#xD;
      oxycode( as necessary).&#xD;
&#xD;
      The families would ask to follow treatment protocols for 7 days. From the first to the 7th&#xD;
      day after the operation , the parents would ask to fill a questionnaire every day for&#xD;
      assessment of pain intensity by visual analouge scale(VAS) , the numbers of painkillers taken&#xD;
      daily, the number of times the child awaking at night due to pain, the amount of fluids&#xD;
      intake daily, the time of commencement of regular oral intake.&#xD;
&#xD;
      patient would follow up 7-14 days after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was approved by the regional ethics committe of the Hospital. The participants&#xD;
      would be: Children (2-18 years old, male and female), who will have the indication of&#xD;
      tonsillectomy and will undergo classic tonsillectomy with or without adenoidectom in&#xD;
      otolaryngology departement in HaEmek Hospital and they ate already honey in their lives.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  Allergy to honey&#xD;
&#xD;
        -  Allergy to Acetaminophen&#xD;
&#xD;
        -  Patients with Diabeties mellitus&#xD;
&#xD;
        -  pregnent/breast feeding patients&#xD;
&#xD;
        -  patients with coagulation disorders&#xD;
&#xD;
        -  patients who undrego another operation in addition to tonsillectomy with or without&#xD;
           adenoidectomy ( except insertion of ventilation tubes surgery).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>randomized clinical trials that included 2 armes: the control group and the case group</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>7 days</time_frame>
    <description>pain intensity by visual analouge scale(VAS), the numbers of painkillers taken daily, the number of times the child awaking at night due to pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of fluids</measure>
    <time_frame>7 days</time_frame>
    <description>what is the amount of fluids intake daily</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The time of commencement of regular oral intake.</measure>
    <time_frame>7-14 days</time_frame>
    <description>How long is take post surgery for the child to return to his regular oral intake</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>After the surgery, during the hospitalization ,the control group would get as is customary in our ENT department :acetaminophen syrup+ syrup oxycode( as necessary).&#xD;
After the discharge from the hospital - the patients would take( as is customary in our ENT department): acetaminophen syrup ( as necessary) and other painkillers ( as necessary).&#xD;
The families would ask to follow treatment protocols for 7 days and will fill a questionnarie every day during the 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>case group-&quot;HONEY&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After the surgery, during the hospitalization ,the case group would instructed to use honey twice a day( 5 ml- one tea spoon each time)+acetaminophen syrup + syrup oxycode( as necessary).&#xD;
After the discharge from the hospital - the patients would take:acetaminophen syrup ( as necessary) and other painkillers+honey twice a day( 5 ml- one tea spoon each time) .&#xD;
The families would ask to follow treatment protocols for 7 days and will fill a questionnarie every day during the 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HONEY</intervention_name>
    <description>100% Natural pure Honey, produced by EIN HAROD CO-OPERATIVE, ISRAEL</description>
    <arm_group_label>case group-&quot;HONEY&quot;</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children ages 2-18 years old that candidates for Tonsillectomy with or without&#xD;
             adenoidectomy surgery, in otolaryngolgy department , HaEmek Hospital, Afula.&#xD;
&#xD;
          -  Parents' signature on informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to honey&#xD;
&#xD;
          -  Allergy to Acetaminophen&#xD;
&#xD;
          -  Patients with Diabeties mellitus&#xD;
&#xD;
          -  pregnent/breast feeding patients&#xD;
&#xD;
          -  patients with coagulation disorders&#xD;
&#xD;
          -  patients who undrego another operation in addition to tonsillectomy with or without&#xD;
             adenoidectomy ( except insertion of ventilation tubes surgery).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>tzvi chen</last_name>
    <role>Study Chair</role>
    <affiliation>haemek medical center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>tzvi chen</last_name>
    <role>Study Director</role>
    <affiliation>haemek medical center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>TZVI CHEN</last_name>
    <role>Principal Investigator</role>
    <affiliation>haemek medical center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tzvi Chen, MD</last_name>
    <phone>972-546151054</phone>
    <email>tzvikachen@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>HaEmek Medical Center</name>
      <address>
        <city>'Afula</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tzvi chen, MD</last_name>
      <phone>972546151054</phone>
      <email>TZVIKACHEN@GMAIL.COM</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>February 27, 2018</last_update_submitted>
  <last_update_submitted_qc>February 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03296020
org study id: 0079-17-EMC
nct id: NCT03296020
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the effect of honey administration on pain following
      pediatric tonsillectomy or adenotonsilectomy.

      The patients( children 2-18 years old) will divide into two groups by simple randomization
      method( the control group and the case group).

      After surgery the case group: would instructed to use honey twice a day( 5 ml- one tea spoon
      each time)+acetaminophen syrup+ syrup oxycode( as necessary).

      the control group would get as is customary in our ENT department :acetaminophen syrup+ syrup
      oxycode( as necessary).

      The families would ask to follow treatment protocols for 7 days. From the first to the 7th
      day after the operation , the parents would ask to fill a questionnaire every day for
      assessment of pain intensity by visual analouge scale(VAS) , the numbers of painkillers taken
      daily, the number of times the child awaking at night due to pain, the amount of fluids
      intake daily, the time of commencement of regular oral intake.

      patient would follow up 7-14 days after surgery.
This study was approved by the regional ethics committe of the Hospital. The participants
      would be: Children (2-18 years old, male and female), who will have the indication of
      tonsillectomy and will undergo classic tonsillectomy with or without adenoidectom in
      otolaryngology departement in HaEmek Hospital and they ate already honey in their lives.

      Exclusion criteria:

        -  Allergy to honey

        -  Allergy to Acetaminophen

        -  Patients with Diabeties mellitus

        -  pregnent/breast feeding patients

        -  patients with coagulation disorders

        -  patients who undrego another operation in addition to tonsillectomy with or without
           adenoidectomy ( except insertion of ventilation tubes surgery).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized clinical trials that included 2 armes: the control group and the case group
primary purpose: Other
masking: None (Open Label)
measure: Pain intensity
time frame: 7 days
description: pain intensity by visual analouge scale(VAS), the numbers of painkillers taken daily, the number of times the child awaking at night due to pain
measure: Amount of fluids
time frame: 7 days
description: what is the amount of fluids intake daily
measure: The time of commencement of regular oral intake.
time frame: 7-14 days
description: How long is take post surgery for the child to return to his regular oral intake
arm group label: control group
arm group type: No Intervention
description: After the surgery, during the hospitalization ,the control group would get as is customary in our ENT department :acetaminophen syrup+ syrup oxycode( as necessary).
After the discharge from the hospital - the patients would take( as is customary in our ENT department): acetaminophen syrup ( as necessary) and other painkillers ( as necessary).
The families would ask to follow treatment protocols for 7 days and will fill a questionnarie every day during the 7 days.
arm group label: case group-"HONEY"
arm group type: Experimental
description: After the surgery, during the hospitalization ,the case group would instructed to use honey twice a day( 5 ml- one tea spoon each time)+acetaminophen syrup + syrup oxycode( as necessary).
After the discharge from the hospital - the patients would take:acetaminophen syrup ( as necessary) and other painkillers+honey twice a day( 5 ml- one tea spoon each time) .
The families would ask to follow treatment protocols for 7 days and will fill a questionnarie every day during the 7 days.
intervention type: Other
intervention name: HONEY
description: 100% Natural pure Honey, produced by EIN HAROD CO-OPERATIVE, ISRAEL
arm group label: case group-"HONEY"
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: tzvi chen
role: Study Chair
affiliation: haemek medical center
last name: tzvi chen
role: Study Director
affiliation: haemek medical center
last name: TZVI CHEN
role: Principal Investigator
affiliation: haemek medical center
last name: Tzvi Chen, MD
phone: 972-546151054
email: tzvikachen@gmail.com
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: Undecided