A Randomized Double-blind Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Moderate Vomiting Due to Acute Gastroenteritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of good outcome, defined as 1 episode or less of vomiting 24 hours after the first dose of drug administration.
研究概览
简要总结
Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis.
RESEARCH QUESTION
Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
详细描述
STRUCTURED RESEARCH ABSTRACT
Background: The use of antiemetic drugs to treat nausea and vomiting during an episode of acute gastroenteritis in children remains controversial. To date, there have been a limited number of clinical trials studying this subject matter and health authorities' recommendations are only based on expert opinion. Surveys have shown that despite this lack of evidence, physicians do quite frequently prescribe these drugs. Dimenhydrinate, a histamine receptor blocker, has been proven safe and effective in controlling post-operative nausea and vomiting in children. To our knowledge, no clinical trial has been conducted to study its efficacy in children with acute gastroenteritis.
Objective: To evaluate the efficacy and safety of oral dimenhydrinate in the treatment of vomiting due to acute gastroenteritis in children.
Design: Randomized, double-blind, placebo controlled clinical trial.
Setting: Emergency Department (ED) of an urban pediatric university-affiliated center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged from 1 to 12 years old with more than 5 episodes of vomiting in the 12 hours preceding their diagnosis of acute gastroenteritis by an ED attending physician
排除标准
- •Pre-existing chronic medical condition such as gastro-intestinal disease, malignancy, metabolic, cardiac, endocrine, immunologic or neurologic disorder
- •Suspected secondary diagnosis of surgical abdomen or gynecologic condition, urinary tract infection, migraine or meningitis
- •Use of antiemetic therapy within 48 hours prior to ED visit
- •Use of medication other than acetaminophen or ibuprofen in the previous 48 hours
- •History of allergy or adverse reaction to dimenhydrinate
- •Severe dehydration requiring immediate intravenous fluid therapy
- •Hematemesis or hematochezia
研究组 & 干预措施
Dimenhydrinate
dimenhydrinate PO x 4 doses
干预措施: Dimenhydrinate (Drug)
Placebo
placebo PO x 4 doses
干预措施: Placebo (Drug)
结局指标
主要结局
Number of good outcome, defined as 1 episode or less of vomiting 24 hours after the first dose of drug administration.
时间窗: 24 hours
次要结局
- Need for intravenous fluid administration(24 hours)
- Number and duration of vomiting and diarrhea(7 days)
- Side effects(7 days)
- Revisit rates(7 days)
- Parental absenteeism from work will be compared between the two groups(7 days)
研究者
Serge Gouin
Associate professor
St. Justine's Hospital