Single Intraoperative Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Full Oral Course in Prevention of Post Adenotonsillectomy Morbidity:A Randomised Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- POSTOPERATIVE FEVER
研究概览
简要总结
Null hypothesis; The efficacy of Enhancin]Co-Amoxiclav given as a single intravenous dose at induction is not better than a five days oral course of the same given postoperatively in reducing postoperative morbidity after adenotonsillectomy.
详细描述
Adenotonsillectomy results in morbidity that is reduced by the use of antibiotics.This study had the sole objective of comparing two route of administration to see which has superior results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients below 12year scheduled to undergo adenotonsillectomy whose parents or guardians give consent for recruitment into the study.
排除标准
- •Non consenting parents or guardians. Antibiotic use in the week preceding surgery. Patients with co mordities. Known allergies to Co-amoxiclav. Patients who develop complication that warrant change of antibiotic.
研究组 & 干预措施
Intravenous intraoperative Enhancin
Patients received a dose of intravenous Enhancin at induction and only oral Paracetamol in the postoperative period.
干预措施: Enhancin (Drug)
Postoperative oral Enhancin.
Patients received postoperative oral Enhancin for five days in addition to oral Paracetamol for the same duration. They did not receive an antibiotic during the operation.
干预措施: Enhancin (Drug)
结局指标
主要结局
POSTOPERATIVE FEVER
时间窗: OPERATION DAY TO 7 DAYS POSTOPERATIVELY
Temperature monitored at 1st ,4th and 7th postoperative days.
次要结局
未报告次要终点