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The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
HONEY
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Pain

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • children ages 2-18 years old that candidates for Tonsillectomy with or without adenoidectomy surgery, in otolaryngolgy department , HaEmek Hospital, Afula.
  • Parents' signature on informed consent form.

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).

Sites / Locations

  • HaEmek Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

case group-"HONEY"

Arm 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.

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.

Outcomes

Primary Outcome Measures

Pain intensity
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
Amount of fluids
what is the amount of fluids intake daily
The time of commencement of regular oral intake.
How long is take post surgery for the child to return to his regular oral intake

Secondary Outcome Measures

Full Information

First Posted
September 25, 2017
Last Updated
February 27, 2018
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT03296020
Brief Title
The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study
Official Title
The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
October 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized clinical trials that included 2 armes: the control group and the case group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm 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 Title
case group-"HONEY"
Arm Type
Experimental
Arm 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(s)
HONEY
Intervention Description
100% Natural pure Honey, produced by EIN HAROD CO-OPERATIVE, ISRAEL
Primary Outcome Measure Information:
Title
Pain intensity
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
Time Frame
7 days
Title
Amount of fluids
Description
what is the amount of fluids intake daily
Time Frame
7 days
Title
The time of commencement of regular oral intake.
Description
How long is take post surgery for the child to return to his regular oral intake
Time Frame
7-14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: children ages 2-18 years old that candidates for Tonsillectomy with or without adenoidectomy surgery, in otolaryngolgy department , HaEmek Hospital, Afula. Parents' signature on informed consent form. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tzvi Chen, MD
Phone
972-546151054
Email
tzvikachen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tzvi chen
Organizational Affiliation
haemek medical center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
tzvi chen
Organizational Affiliation
haemek medical center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
TZVI CHEN
Organizational Affiliation
haemek medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
HaEmek Medical Center
City
'Afula
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tzvi chen, MD
Phone
972546151054
Email
TZVIKACHEN@GMAIL.COM

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study

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