Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide: Randomized Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain Change
研究概览
简要总结
One of the most common complaints of admission to the emergency room is gastroenteritis. One of the most common complaints in acute gastroenteritis is abdominal pain. The aim of our study is to investigate whether hyoscine butylbromide used within the indication has an effect on abdominal pain due to acute gastroenteritis. The main purpose of our study is to reduce the pain of the patient at 30th and 60th minutes compared to 0th minute.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with watery stools starting in the last 2 weeks and 3 times in 24 hours and abdominal pain
排除标准
- •Peritonitis
- •Hemodynamic instability
- •Pregnancy
- •Inability to give consent
- •Medication given in the emergency room before being included in the study
- •Taking pain medication within 4 hours
- •Diabetes Mellitus and other neuropathic diseases
研究组 & 干预措施
Placebo
In the placebo arm, patients will be slowly injected with 2 ml of normal saline within 30 seconds
干预措施: Placebo (Other)
Hyoscine N butylbromide
In the treatment arm, the patient will be injected intravenously with 1ml 20 mg of Hyoscine butylbromide and 1 ml of normal saline intravenously within 30 seconds.
干预措施: Hyoscine N Butylbromide (Drug)
结局指标
主要结局
Pain Change
时间窗: 30 minute and1 hour
Pain change after intervention at 30th and 60th minute. Pain will assesed with Visual Analog Scale (100 mm). 13 mm of change at Visual Analog Scale will assesed as clinically significant.
次要结局
未报告次要终点
研究者
Cagdas Yildirim
Ass. Prof.
Ankara City Hospital Bilkent