Triage Administration of Ondansetron for Gastroenteritis in Children; a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Disposition
研究概览
简要总结
The investigators aim to assess whether ondansetron given at triage can reduce the number of patients requiring emergency department observation in children with acute gastroenteritis. The investigators will also assess the improvement of patient comfort and total length of stay
详细描述
Background:
Acute gastroenteritis is one the most common cause of emergency room visits. Studies have demonstrated that ondansetron is effective in reducing vomiting in children with gastroenteritis and improve outcomes by decreasing intravenous rehydration and hospital admission of those patients. Giving ondansetron to children with suspected gastroenteritis immediately at triage could reduce the number of patients requiring observation in the emergency department after medical consultation and improve patients' outcomes.
Objective:
The aim of this study is to assess the effectiveness of triage-initiated administration of ondansetron for suspected gastroenteritis in the paediatric emergency department. The investigators aim to assess whether ondansetron given at triage can reduce the number of patients requiring observation in children with acute gastroenteritis. The investigators will also assess the improvement of patient comfort and total length of stay.
Methods:
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
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged more than 6 months and weight ≥ 8kg
- •At least 4 non-bilious, non-bloody vomiting in the preceding 24 hours
- •The last vomiting occured less than 2 hours ago
- •No other diagnostic more likely than gastroenteritis suspected by the nurse at triage.
排除标准
- •Severe dehydration (based on poor capillary refill or hypotension)
- •Underlying disease that could affect the assessment of hydration (such as renal failure or hypoalbuminemia)
- •Bilious or bloody vomiting
- •Bloody stool
- •A history of abdominal surgery
- •Allergy to ondansetron
- •Long QT syndrome or major cardiac condition
- •Previous enrolment in the study.
- •Girl at risk of pregnancy (pubertal girl)
- •Inability to obtain parental informed consent (language barrier, absence, etc.)
研究组 & 干预措施
Ondansetron
Patients allocated to this arm will receive ondansetron in the ED triage. Posology of ondansetron will be adapted to weight: doses of 2 mg for children weighting between 8 and 15 kg, 4 mg for children weighting between 15 to 30 kg and 8 mg for children heavier than 30 kg
干预措施: Ondansetron (Drug)
control
Patients allocated to this arm will receive an identical looking/tasting placebo in the ED triage.
干预措施: Placebos (Drug)
结局指标
主要结局
Disposition
时间窗: 12 hours
The number of patients that are discharged immediately after initial medical assessment
次要结局
- Length of Stay(12 hours)
- ED vomiting(12 hours)
- 48 hours vomiting(48 hours)
- Return visit(48 hours)
- Nausea level(12 hours)
- Alternative diagnosis(12 hours)
- Left without being sen(12 hours)
- Rescue medication(12 hours)
研究者
Jocelyn Gravel
Principal investigator
St. Justine's Hospital