Comparison of Ondansetron Oral Solution to Orally Disintegrating Tablets for the Management of Suspected Viral Gastroenteritis in a Pediatric Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 462
- 试验地点
- 1
- 主要终点
- proportion of patients who vomit within 15 minutes of administration of anti-emetic
研究概览
简要总结
In children aged 3 months to 10 years who present to the Pediatric Emergency Department (PED) with recent, significant vomiting and moderate dehydration, is treatment with Ondansetron Orally Disintegrating Tablet (ODT) better tolerated than treatment with Ondansetron Oral Solution (OS)? Our hypothesis is that children who receive Ondansetron ODT will have 10% less vomiting within 15 minutes of administration than those receiving Ondansetron OS.
详细描述
Vomiting related to viral gastroenteritis is the most common presentation to the Alberta Children's Hospital Pediatric Emergency Department. Recently, a clinical pathway was implemented to improve the care and flow of patients with vomiting and/or diarrhea through the department. Administration of an antiemetic, Ondansetron, is an integral part of improving the hydration status of children managed by the pathway. However it is not know whether Oral Solution or Oral Disintegrating Tablets are better tolerated in children who have active vomiting. The investigators aim to show that children receiving Oral Disintegrating Tablets have less vomiting immediately after medication administration than children receiving Oral Solution. By demonstrating this improved tolerability the investigators will provide health care providers the stimulus for implementing Ondansetron Oral Disintegrating Tablets into their practice for children with active vomiting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3 months to 10 years with recent,
- •significant vomiting and moderate dehydration who are managed according to the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting & Diarrhea Pathway.
- •The following definitions are used to determine inclusion according to the pathway: Recent, significant vomiting - Vomiting at least 6 episodes in the past 6 hours and at least once in the past hour; Moderate dehydration (Gorelick Score 2) - Two of the following: capillary refill time greater than 2 seconds, absence of tears, dry mucous membranes, ill general appearance.
排除标准
- •Children who are excluded from the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting & Diarrhea Pathway.
- •These criteria include: Vomiting or Diarrhea for greater than 7 days, Localized abdominal pain, Chronic medical conditions affecting major organ systems (Ex, diabetes, PKU, immunodeficiency), Likely GI Obstruction (abdominal distension, bilious vomiting, absent bowel sounds), Weight less than 8kg. Children who have received anti-emetics at home will not be excluded but will be tracked.
结局指标
主要结局
proportion of patients who vomit within 15 minutes of administration of anti-emetic
时间窗: 15 minutes
To determine the proportion of patients aged 3 months to 10 years who present to the PED with recent significant vomiting and moderate dehydration who vomit within 15 minutes of receiving either Ondansetron Oral Solution versus Orally Disintegrating Tablets.
次要结局
- # episodes of vomiting after ondansetron administration(While in the ED, anticipated to be on average < 5 hours)
- Discharged home without IV(Duration of ED visit, anticipated to be on average < 5 hours)
研究者
Dr. Graham Thompson
Physician
Alberta Children's Hospital