ISRCTN53730137已完成不适用
Doubleblind randomised multicenter trial to investigate the influence of dimenhydrinate suppositories versus placebo on oral rehydration in infants and children with infectious enteritis and vomiting
niversity of Leipzig (Germany)0 个研究点目标入组 270 人开始时间: 2005年10月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Acute vomiting started 8-24 hours prior to the inclusion due to suggested infectious enteritis with at least 2 episodes of vomiting in the last 12 hours
- •2. Age: 6 months-5 years
- •3. Weight over 7,000 g
- •4. Outpatients
- •5. Informed consent of at least one caregiver
排除标准
- •1. Contraindications against the study drug
- •2. Receipt of the following medications:
- •2.1. Treatment with medicinal products with suspected interactions with dimenhydrinate
- •2.2. Treatment with antiemetics or secretion inhibitors
- •3. Severe disease with one of the following criteria:
- •3.1. Bloody stool with this disease
- •3.2. Suggested requirement of intravenous (IV) rehydration
- •3.3. Confirmed weight loss of more than 7.5% body weight
- •3.4. Metabolic acidosis (i.e. pH <7.25) and/or electrolyte disturbances (measured by blood test in the emergency clinic originated in the responsibility of the investigator)
- •4. Suspected lack of cooperation and compliance by the patient or the caregiver(s) or linguistic problems of the parents
- •5. Participation in other medical trials
研究者
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