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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03296020
• Other study ID #: 0079-17-EMC
• Status: Recruiting
• Phase: N/A
• First received: September 25, 2017
• Last updated: February 27, 2018
• Start date: November 1, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: February 2018
• Source: HaEmek Medical Center, Israel
• Contact: Tzvi Chen, MD
• Phone: 972-546151054
• Email: tzvikachen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• HONEY
100% Natural pure Honey, produced by EIN HAROD CO-OPERATIVE, ISRAEL

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	'Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Amount of fluids	what is the amount of fluids intake daily	7 days
Primary	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