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Antiemetic Efficacy of Ondansetron Versus Metoclopramide

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ClinicalTrials.gov Identifier: NCT02619201
Recruitment Status : Unknown
Verified October 2015 by Hospital General Naval de Alta Especialidad - Escuela Medico Naval.
Recruitment status was:  Not yet recruiting
First Posted : December 2, 2015
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Hospital General Naval de Alta Especialidad - Escuela Medico Naval

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


Condition or disease Intervention/treatment Phase
Acute Gastroenteritis Vomiting Drug: Ondansetron Drug: metoclopramide Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy of Ondansetron Versus Metoclopramide for Vomiting in Children With Acute Gastroenteritis: Randomized Controlled Clinical Trial
Study Start Date : November 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : November 2016


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 Name: 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 Name: MT




Primary Outcome Measures :
  1. Cumulative rate of vomiting after cessation of drug administration [ Time Frame: 4 hours ]


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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619201


Contacts
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Contact: Yaneth Miranda Tecuautzin, medicine 66 91 60 07 39 missin1821@hotmail.com
Contact: Jose de Jesus Gutierrez Escobedo, medicine 5516910741 abi2228@msn.com

Sponsors and Collaborators
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Investigators
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Principal Investigator: Yaneth Miranda Tecuautzin, medicine Secretaria de Marina-Armada de México (Mexican Navy)
Publications:

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Responsible Party: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
ClinicalTrials.gov Identifier: NCT02619201    
Other Study ID Numbers: HGNAE-10
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: October 2015
Keywords provided by Hospital General Naval de Alta Especialidad - Escuela Medico Naval:
vomiting in children
ondansetron
metoclopramide
antiemetics
Additional relevant MeSH terms:
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Gastroenteritis
Vomiting
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Digestive System Diseases
Ondansetron
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents