NCT04318847Unknown4 期
Efficacy and Safety of the Administration of Ondansetron Versus Habitual Clinical Practice for the Treatment of Vomiting in Children With Mild and Moderate Dehydration: Randomized Clinical Trial
Lizar Aguirre Pascasio0 个研究点目标入组 220 人开始时间: 2021年10月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 220
- 主要终点
- Percentage of children who return to medical/pediatric consultation for de same episode
研究概览
简要总结
This clinical trial is intended to evaluate the efficacy and safety of the administration of ondansetron in children with mild-moderate dehydration.
The target population will be children between 4 and 13 years old who present vomiting.
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
- None
入排标准
- 年龄范围
- 4 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of at least 2 vomits in the last 4 hours.
- •Negative tolerance test.
- •Signature of the informed consent by the parents or legal guardians.
- •Diagnosis of vomiting or diagnosis of acute gastroenteritis with vomiting.
- •Patients weighing 15 kg or more.
排除标准
- •Altered conciousness.
- •Sospected acute abdomen (appendicitis, invaginations...).
- •Suspicion or presence of obstructive disease.
- •Known severe digestive disease (Chron´s disease, ulcerative colitis...).
- •Suspected food poisoning.
- •Allergy to any of the drugs used in the study.
- •Severe dehydration.
- •Bilious vomiting.
- •Previous abdominal surgery.
- •Pathology that may affective degree of hydration of the patient (kidney failure, hypoalbuminemia..).
- •Admission requirement or intravenous rehydration for any reason.
- •Concomitant use of apomorphine.
- •In relation to the possible lengthening of the QT, patients with problems of previous arrhythmia should be excluded or that they are receiving concomitant medication that can lengthen the QT, that have electrolyte disturbances.
- •Patients receiving other serotonergic drugs.
- •Patients who have undergone a previous adenotonsillectomy.
- •Patients with hypocalcemia and/or hypomagnesemia.
- •Patients with hereditary fructose intolerance.
- •Diabetes patients.
- •Lactose intolerant patients.
- •Patients with indication of the low sodium diets.
- •Hypersensitivity to ondansetron or other antagonists of the 5-HT3.
研究组 & 干预措施
Ondransetron
Experimental
Administration of ondansetron
干预措施: Ondansetron 4 MG (Drug)
结局指标
主要结局
Percentage of children who return to medical/pediatric consultation for de same episode
时间窗: An average of 24 months
Is calculated percentage of children who return to medical/pediatric consultation for de same episode of vomiting
次要结局
未报告次要终点
研究者
Lizar Aguirre Pascasio
Doctor in Medicine
Basque Health Service
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