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临床试验/NCT00662987
NCT00662987已完成不适用

Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2005年9月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

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

Active Comparator

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)

研究者

申办方类型
Other

研究点 (1)

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