Assessment of Analgesic Efficacy and Safety of Intravenous Hyoscine-N-Butylbromide in Patients With Abdominal Colic Associated With Acute Gastroenteritis; a Randomized, Double-blind, Placebo Controlled Study
试验速览
- 阶段
- 4 期
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in the mean pain intensity scores on visual analog scale
研究概览
简要总结
This study aims to assess the analgesic efficacy and safety of intravenous 20 mg Hyoscine-N-Butylbromide versus placebo for the treatment of abdominal colic associated with acute gastroenteritis in the emergency department.
详细描述
Acute gastroenteritis is a frequent cause of emergency department (ED) presentation. Mainstays of ED treatment are rehydration and antiemetics when needed. Since crampy abdominal pain accompanies (diarrhea) acute gastroenteritis in 67-90% of patients, emergency physicians may have to deal with spasmodic colics in these patients.
Hyoscine-N-butylbromide (HNB), is an anticholinergic agent which has been in use as an antispasmodic agent for sixty years all over the world. It has been studied and revealed various efficacy for several conditions (e.g; biliary colic, renal colic, endoscopic interventions, radiologic interventions, during labor, nonspecific abdominal pain and irritable bowel syndrome).
HNB is commonly used for symptomatic relief of abdominal cramps associated with acute gastroenteritis in the EDs, whereas the literature lacks evidence regarding its efficacy and safety for this condition.
The aim of this study is to assess the analgesic efficacy and safety of intravenous 20 mg hyoscine-n-butylbromide versus placebo in patients with abdominal colic associated with acute gastroenteritis in the emergency department.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Presenting to the emergency department with abdominal cramps associated with acute gastroenteritis
- •The pain intensity score upon screening is at least 20 mm on visual analog scale
- •Patients who agree to participate and sign the informed consent
排除标准
- •Patients younger than 18 years
- •Pain of > 7 days
- •Use of any analgesic within 6 hours of ED presentation
- •Concomitant medication with spasmolytics, anticholinergics, drugs affecting gastrointestinal motility such as metoclopramide, loperamide, opioid analgesics
- •Patients who were administered dopamine antagonists before screening
- •Documented or self-reported hypersensitivity to hyoscine-n-butylbromide
- •Confirmed or suspected pregnancy
- •Breastfeeding
- •Myasthenia gravis
- •Benign prostatic hyperplasia or urinary obstruction
- •Any suspected other cause of acute abdominal pain
- •Peritonism
- •Mechanical stenosis of the gastrointestinal tract, paralytic ileus, megacolon
- •Previous intestinal resection
- •History of inflammatory bowel disease
- •Tachyarrhythmia
- •Severe dehydration requiring fluid resuscitation immediately
- •Unable to consent
- •Refused to participate
研究组 & 干预措施
Hyoscine-N-Butylbromide
20 mg Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL)
干预措施: Hyoscine-N-Butylbromide (Drug)
Placebo
100 mL normal saline
干预措施: Hyoscine-N-Butylbromide (Drug)
结局指标
主要结局
Change in the mean pain intensity scores on visual analog scale
时间窗: 15, 30, 60 minutes
Change in the mean pain intensity scores on visual analog scale
次要结局
- Incidence of rescue analgesia(at 30 minute)
- Adverse events(6 hours)
研究者
Elif Yaka
Assistant Professor
Kocaeli University