The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Pain intensity
时间窗: 7 days
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 time of commencement of regular oral intake.
时间窗: 7-14 days
How long is take post surgery for the child to return to his regular oral intake
Amount of fluids
时间窗: 7 days
what is the amount of fluids intake daily
次要结局
未报告次要终点