Antiemetic Efficacy of Ondansetron Versus Metoclopramide

Study Overview
=================
Brief Summary
-----------------
Acute gastroenteritis (GEA) is a public health problem at present, the main cause of vomiting and consultation in emergencies in children under 5 years. Worldwide, there are about 2 million deaths per year due to gastroenteritis in children under 5 years. In Mexico, the mortality rate by age in 2013, recorded 28 deaths per 100,000 boys and girls, in 2013 in our country 2.5 million children between 5 and 17 years engaged in an economic activity. The occupancy rate for the child population was 8.6: 11.4 for boys and 5.8 for girls. NICE guidance gastroenteritis defined as a transient disorder caused by an enteric infection and characterized by a sudden onset of diarrhea with or without vomiting

Detailed Description
-----------------
It will be conducted a randomized controlled double-blinded study in the Emergency service of the Naval General Hospital of High Specialty in the Mexico City. The period of patient inclusion in the study is November 2015 to November 2016. The selections of the patients are children between 1 and 5 years who come to the emergency room with symptoms of acute gastroenteritis with vomiting and intolerance of oral route. Treatments were randomly assigned eligible patients on admission in the emergency department The primary endpoint was evaluated at 15 minutes after treatment application: Treatment 1: Ondansetron was administered intravenous dose (0.15mg/kg/doses) Diluted in 20 ml saline and administered intravenously 5 minutes Treatment 2: Metoclopramide was administered intravenous dose (0.15mg/kg/doses) Diluted in 20 ml saline and administered intravenously 5 minutes The administration of intravenous medications, will be held in the observation area of the emergency department of pediatrics under monitoring continuo vital signs during application and 15 minutes after treatment. At 15 minutes after administration, the mouth with oral electrolyte begins by assessing your tolerance, 30 minutes to progress to the astringent diet. It will follow up with patient assessment in the emergency department of pediatrics, 3 hours after having established the treatment, in order to corroborate the remission of vomiting, it is graduation of home otherwise he will enter hospital. Primary objective Cumulative rate of cessation of vomiting secondary objectives Compare the number of vomiting episodes with the administration of ondansetron vs metoclopramide Compare time duration in which the oral route is restarted. Compare hospital admission rate Describe adverse effects in both groups Inclusion Criteria: Orally intolerance More than 2 vomiting in the last 24 hours Without antiemetic therapy within 24 hours of the clinical picture Patients with or without diarrhea Exclusion Criteria: Previous abdominal surgery Suspected surgical abdominal vomiting bile Hypersensitivity to Ondansetron and Metoclopramide

Official Title
-----------------
Comparison of Efficacy of Ondansetron Versus Metoclopramide for Vomiting in Children With Acute Gastroenteritis: Randomized Controlled Clinical Trial

Conditions
-----------------
Acute Gastroenteritis, Vomiting

Intervention / Treatment
-----------------
* Drug: Ondansetron
* Drug: metoclopramide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Orally intolerance More than 2 vomiting in the last 24 hours Without antiemetic therapy within 24 hours of the clinical picture Patients with or without diarrhea Exclusion Criteria: Previous abdominal surgery Suspected surgical abdominal Vomiting bile Hypersensitivity to Ondansetron and Metoclopramide

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ondansetron<br>An intravenous dose of ondansetron ( 0.15mg /kg / doses ) Diluted in 20 ml of saline and administer intravenously in 5 minutes | Drug: Ondansetron<br>* An intravenous dose of ondansetron ( 0.15mg /kg / doses ) .<br>* Other names: OD;|
| Active Comparator: metoclopramide<br>An intravenous dose of metoclopramide ( 0.15mg /kg / doses ) Diluted in 20 ml of saline and administer intravenously in 5 minutes | Drug: metoclopramide<br>* An intravenous dose of metoclopramide ( 0.15mg /kg / doses ) .<br>* Other names: MT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative rate of vomiting after cessation of drug administration |  | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vomiting in children, ondansetron, metoclopramide, antiemetics