The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study
NCT ID: NCT03296020
Last Updated: 2018-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2017-11-01
2018-10-01
Brief Summary
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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.
Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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control group
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.
No interventions assigned to this group
case group-"HONEY"
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.
HONEY
100% Natural pure Honey, produced by EIN HAROD CO-OPERATIVE, ISRAEL
Interventions
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HONEY
100% Natural pure Honey, produced by EIN HAROD CO-OPERATIVE, ISRAEL
Eligibility Criteria
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Inclusion Criteria
* Parents' signature on informed consent form.
Exclusion Criteria
* 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).
2 Years
18 Years
ALL
Yes
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Principal Investigators
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tzvi chen
Role: STUDY_CHAIR
haemek medical center
tzvi chen
Role: STUDY_DIRECTOR
haemek medical center
TZVI CHEN
Role: PRINCIPAL_INVESTIGATOR
haemek medical center
Locations
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HaEmek Medical Center
Afula, , Israel
Countries
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Central Contacts
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Facility Contacts
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Tzvi chen, MD
Role: primary
Other Identifiers
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0079-17-EMC
Identifier Type: -
Identifier Source: org_study_id