Ondansetron Vs Metoclopramide in the Treatment of Vomiting in Gastroenteritis Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- is the proportion of patients with cessation of vomiting after study medication administration in each group.
研究概览
简要总结
Is intravenous metoclopramid as effective as intravenous ondansetron in the treatment of persistent vomiting in patients with acute gastroenteritis.
详细描述
In this study, we will compare the efficacy of a single intravenous dose of ondansetron versus intravenous metoclopramide in the treatment of persistent vomiting in simple gastroenteritis in a larger RCT.
PEC Al Saad is the main Pediatric Emergency Center in the state of Qatar with approximately 200,000 visits annually. It has a capacity of 42 observation beds providing most of the inpatient facilities except for intensive care monitoring. Patients admitted to the PEC are managed there for 48 hours or longer if needed, they are then transferred to Hamad General Hospital for further investigation and completion of their treatment. Hamad General Hospital is the main tertiary care hospital in Qatar with a capacity of around 100 pediatric beds.
All acute gastroenteritis patient between 1-14 years presenting to PEC Al Saad with diarrhea, persistent vomiting , fail oral rehydration and admitted to the observation unit for intravenous hydration will be eligible for the study.
Patients were excluded from the study if they had one or more of the following: Previous abdominal surgery,Suspicion of surgical abdominal,Bile stained vomitus,History of hepatic illness,Metabolic diseases, including diabetes mellitus and in-born error of metabolism,Children with shock or impending shock,Sever dehydration,Previous hypersensitivity or abnormal reaction to metoclopramide or ondansetron,Parenteral antiemetic treatment in the previous 24hrs or Seizure disorder
One group will receive a single IV dose of Ondansetron after enrollment and the second group will receive a single IV dose of Metoclopramide On arrival to the PEC, patients with simple gastroenteritis will be assessed by the pediatric specialist on-call, patients with persistent vomiting who fail ORS therapy will be admitted for observation and management as usual. The pediatric specialist in the observation room will take history, perform full physical examination and evaluate the degree of dehydration . Patients will be assessed for eligibility to the study based on the aforementioned inclusion criteria.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All acute gastroenteritis patient between 1-14 years presenting to PEC Al Saad with diarrhea, persistent vomiting , fail oral rehydration and admitted to the observation unit for intravenous hydration will be eligible for the study.
排除标准
- •Previous abdominal surgery
- •Suspicion of surgical abdominal
- •Bile stained vomitus
- •History of hepatic and renal illnesses
- •In-born error of metabolism
- •Children with shock or impending shock
- •Sever dehydration.
- •Previous hypersensitivity or abnormal reaction to metoclopramide or ondansetron
- •Antiemetic treatment within 48 hours prior to presentation.
- •Seizure disorder
研究组 & 干预措施
Treatment 1.
Metoclopramide 0.3 mg/kg max 10 mg in burette and mixed with normal saline to make up 50 cc of medication and normal saline as a single intravenous dose. Complete blood count,serum electrolytes,renal function,HCO3 level will be requested.Oral fluid will be started thereafter and increased gradually until patient discharge.
干预措施: Treatment 1. Metoclopramide (Drug)
Treatment2.
Ondansetron 0.15 mg/kg max 4 mg in burette and mixed with normal saline to make up 50 cc of medication and normal saline to be given over 10 minutes,then patient will be kept NPO for one hour after completion of the anti emetic infusion and last episode of vomiting . Oral fluid will be started thereafter and increased gradually until fully tolerated and the patient is ready for discharge
干预措施: Treatment 2 Ondansetron (Drug)
结局指标
主要结局
is the proportion of patients with cessation of vomiting after study medication administration in each group.
时间窗: one year
次要结局
- Time to complete cessation of vomiting, time to successful oral therapy,length of hospital stay, parents perception of the child nausea symptom and oral tolerance on discharge and daily follow up for 3 days.(one year)