Oral Granisetron Versus Oral Ondansetron for Treatment of Gastroenteritis: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- To compare the effectiveness of Granisetron oral solution and Ondansetron oral dispersible film for treatment of vomiting in pediatric patients.
研究概览
简要总结
The current clinical trial will include 160 children who will be presented with vomiting to the Outpatient Department of the Children's Hospital, Faculty of Medicine, Ain Shams University. Participants will be assigned randomly to receive either a dispersible film Ondansetron or oral Granisetron. After initial assessment, both groups will be followed up after 6 and 48 hours to check the frequency of vomiting, diarrhea, fever, headache as well as the return of appetite and the need for further treatment. The impact of nausea and vomiting on patients' daily lives will be assessed using a modified version of the Functional Living Index-Emesis (FLIE).
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 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with vomiting within the past 24 hours, including patients without dehydration and those who have mild to moderate dehydration.
排除标准
- •Patients who are severely dehydrated.
- •Patients who have bloody vomiting.
- •Children with chronic diseases like type 1 diabetes mellitus, end stage renal disease and who are receiving chemotherapy.
- •Patients who have vomiting due to surgical causes like intestinal obstruction.
研究组 & 干预措施
arm I (group A) who will receive dispersible film ondansetron
arm I (group A) who will receive dispersible film ondansetron in a dose of 4 mg for those who will weigh more than 15 Kg up to 30 kg, and 8 mg for those who will weigh more than 30 Kg. The dose will be repeated if the patient had another vomiting episode within 15 minutes of taking the medicine.
干预措施: Ondansetron Oral Film (Drug)
Arm II (group B) who will receive oral Granisetron
Arm II (group B) who will receive oral Granisetron in a dose of 40 microgram/kg/dose; the dose could be repeated if needed after 12 hours.
干预措施: Granisetron Oral Liquid Product (Drug)
结局指标
主要结局
To compare the effectiveness of Granisetron oral solution and Ondansetron oral dispersible film for treatment of vomiting in pediatric patients.
时间窗: at 6 hours and at 48 hours of adminsteration
The number of vomiting episodes.
次要结局
未报告次要终点
研究者
Haya Essam Ibrahim
lecturer of pediatrics
Ain Shams University