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

HaEmek Medical Center, Israel

Status: Unknown

Conditions: Postoperative Pain

Treatments: Other: HONEY

Study type: Interventional

Funder types: Other

Identifiers

NCT03296020

0079-17-EMC

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

control group

No Intervention group

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.

case group-"HONEY"

Experimental group

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.

Treatment:

Other: HONEY