NCT03296020

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

7 months

First QC Date

September 25, 2017

Last Update Submit

February 27, 2018

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (3)

  • 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

    7 days

  • Amount of fluids

    what is the amount of fluids intake daily

    7 days

  • The time of commencement of regular oral intake.

    How long is take post surgery for the child to return to his regular oral intake

    7-14 days

Study Arms (2)

control group

NO INTERVENTION

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.

case group-"HONEY"

EXPERIMENTAL

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.

Other: HONEY

Interventions

HONEYOTHER

100% Natural pure Honey, produced by EIN HAROD CO-OPERATIVE, ISRAEL

case group-"HONEY"

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaEmek Medical Center

Afula, Israel

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Honey

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • tzvi chen

    haemek medical center

    STUDY CHAIR

  • tzvi chen

    haemek medical center

    STUDY DIRECTOR

  • TZVI CHEN

    haemek medical center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzvi Chen, MD

CONTACT

972-546151054tzvikachen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized clinical trials that included 2 armes: the control group and the case group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2017

First Posted

September 28, 2017

Study Start

November 1, 2017

Primary Completion

June 1, 2018

Study Completion

October 1, 2018

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations

IL(1)