Famotidine Versus Placebo in Emergency Pediatric Surgery As a Risk to Postoperative Nausea and Vomiting ꞉ a Comparative Study by Gastric Ultrasound Measurement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum by gastric ultrasound preoperatively and postoperatively by using 5mg famotidine versus placebo as a risk factor of postoperative nausea and vomiting
研究概览
简要总结
The aim of this study is to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum preoperatively and postoperatively by using 5mg famotidine versus placebo as a risk factor of PONV.
详细描述
Gastric ultrasound examinations will be performed preoperatively and postoperatively on patients undergoing emergency surgery in pediatric. Gastric cross-sectional area (CSA) will be measured, in order to estimate the gastric volume. The data that will be obtained will be used to evaluate a difference of the gastric volume between the two groups preoperatively and postoperatively and the possible relationship between the gastric volume difference and postoperative adverse event (PONV).
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 2 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatrics patients aging between 2-13 years .
- •pediatrics undergo urgent surgery (i.e., surgery that cannot be postponed for more than 48 h since clinical onset).
- •PatientPediatrics come in trauma
排除标准
- •PatientPediatrics severly shocked .
- •PatientPediatrics with diffusely distended abdomen as this will obstacle gastric ultrasound .
- •PatientPediatrics with history of hypersenstivity to famotidine .
- •PatientPediatrics with hepatic or renal impairments
研究组 & 干预措施
famotidine plus10ml normal saline
Group A:(n. 25) will receive a 5 mg of famotidine that will be diluted to 10ml normal saline in 2 minutes preinduction.
干预措施: famotidine plus10ml normal saline (Drug)
10ml normal saline
Group B: Controlled group (n. 25) will receive a10ml normal saline preinduction.
干预措施: 10ml normal saline (Other)
结局指标
主要结局
to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum by gastric ultrasound preoperatively and postoperatively by using 5mg famotidine versus placebo as a risk factor of postoperative nausea and vomiting
时间窗: 12 months
to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum by gastric ultrasound preoperatively and postoperatively by using 5mg famotidine versus placebo as a risk factor of postoperative nausea and vomiting
次要结局
未报告次要终点
研究者
Zaher Zaki Zaher
Director
Aswan University Hospital