Clinical trial NCT02619201: Antiemetic Efficacy of Ondansetron Versus Metoclopramide
Official title: Comparison of Efficacy of Ondansetron Versus Metoclopramide for Vomiting in Children With Acute Gastroenteritis: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Gastroenteritis
Vomiting
Keywords: vomiting in children
ondansetron
metoclopramide
antiemetics
Lead sponsor: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Sponsor class: OTHER_GOV
First posted: 2015-12-02
Enrollment: 250
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Cumulative rate of vomiting after cessation of drug administration
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Secretaria de Marina-Armada de México (Mexican Navy)
name: Yaneth Miranda Tecuautzin, medicine
role: PRINCIPAL_INVESTIGATOR
References:
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