Clinical trial NCT03296020: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trials that included 2 armes: the control group and the case group
Primary purpose: OTHER

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).

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).

Primary outcomes:
measure: Pain intensity
timeFrame: 7 days
measure: Amount of fluids
timeFrame: 7 days
measure: The time of commencement of regular oral intake.
timeFrame: 7-14 days
Secondary outcomes:
Other outcomes:
Locations:
city: 'Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
affiliation: haemek medical center
name: tzvi chen
role: STUDY_CHAIR
affiliation: haemek medical center
name: tzvi chen
role: STUDY_DIRECTOR
affiliation: haemek medical center
name: TZVI CHEN
role: PRINCIPAL_INVESTIGATOR
References: