Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- analgesic use
研究概览
简要总结
To determine whether a 3-day course of postoperative antibiotics is effective as a 7-day course in reducing pain and reducing time to resumption of normal diet and activity following pediatric tonsillectomy
详细描述
STUDY DESIGN : A prospective, randomized, placebo-controlled trial METHODS : All pediatric patients (under the age of 18) scheduled to undergo a tonsillectomy with or without adenoidectomy from an outpatient otolaryngology practice will be recruited for the study. Exclusion criteria include prior use of antibiotics 7 days before surgery, penicillin allergy or medical comorbidity necessitating antibiotic use. Preoperative demographic information will be obtained. Tonsillectomy with or without adenoidectomy will be performed by a single surgeon (JJ) using electrocautery. Patients will be randomized to receive either a 3- or 7-day course of amoxicillin. Parents will be asked to record the following information: analgesic use for the first 7 postoperative days, postoperative days the child initiated her usual diet and level of activity and medical treatment for oral hemorrhage or dehydration. Statistical analysis will be performed to determine a real difference between the two groups with regard to analgesic use, resumption to normal diet and activity, and incidence of oral hemorrhage or dehydration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •tonsillectomy with or without adenoidectomy
- •under the age of 18
排除标准
- •penicillin allergy
- •took antibiotics within 7 days of surgery
- •medical comorbidity requiring treatment with antibiotics
研究组 & 干预措施
Group B
Received 3 days of amoxicillin followed by 4 days of placebo
干预措施: 3 days of amoxcillin followed by 4 days of placebo (Drug)
Group A
Received 7 days of amoxicillin
干预措施: 7 days of amoxicillin (Drug)
结局指标
主要结局
analgesic use
时间窗: 1 week
次要结局
- time of resumption of normal diet(1 week)
- time of resumption of normal activity(1 week)
