Antiemetic Efficacy of Ondansetron Versus Metoclopramide

November 30, 2015 updated by: Hospital General Naval de Alta Especialidad - Escuela Medico Naval

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jose de Jesus Gutierrez Escobedo, medicine
  • Phone Number: 5516910741
  • Email: abi2228@msn.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ondansetron
An intravenous dose of ondansetron ( 0.15mg /kg / doses ) Diluted in 20 ml of saline and administer intravenously in 5 minutes
Drug: Ondansetron
An intravenous dose of ondansetron ( 0.15mg /kg / doses ) .
Other Names:
  • OD
Active Comparator: metoclopramide
An intravenous dose of metoclopramide ( 0.15mg /kg / doses ) Diluted in 20 ml of saline and administer intravenously in 5 minutes
Drug: metoclopramide
An intravenous dose of metoclopramide ( 0.15mg /kg / doses ) .
Other Names:
  • MT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative rate of vomiting after cessation of drug administration
Time Frame: 4 hours
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 2, 2015

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGNAE-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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