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Antiemetic Efficacy of Ondansetron Versus Metoclopramide

NCT02619201 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2015-12-02

No results posted yet for this study

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

Conditions

Interventions

DRUG

Ondansetron

An intravenous dose of ondansetron ( 0.15mg /kg / doses ) .

DRUG

metoclopramide

An intravenous dose of metoclopramide ( 0.15mg /kg / doses ) .

Sponsors & Collaborators

  • Hospital General Naval de Alta Especialidad - Escuela Medico Naval

    lead OTHER_GOV

Principal Investigators

  • Yaneth Miranda Tecuautzin, medicine · Secretaria de Marina-Armada de México (Mexican Navy)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-05-31
Completion
2016-11-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02619201 on ClinicalTrials.gov