Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT03296020
Status:
UNKNOWN
Last Update Posted:
2018-02-28
First Post:
2017-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study
Sponsor:
HaEmek Medical Center, Israel
Organization:
Study Overview
Official Title:
The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: