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
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|
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
- 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
- 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
- Previous abdominal surgery
- Suspected surgical abdominal
- vomiting bile
- Hypersensitivity to Ondansetron and Metoclopramide
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
An intravenous dose of ondansetron ( 0.15mg /kg / doses ) Diluted in 20 ml of saline and administer intravenously in 5 minutes
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
An intravenous dose of metoclopramide ( 0.15mg /kg / doses ) .
Other Name: MT
- Cumulative rate of vomiting after cessation of drug administration [ Time Frame: 4 hours ]
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
|Contact: Yaneth Miranda Tecuautzin, medicine||66 91 60 07 email@example.com|
|Contact: Jose de Jesus Gutierrez Escobedo, firstname.lastname@example.org|
|Principal Investigator:||Yaneth Miranda Tecuautzin, medicine||Secretaria de Marina-Armada de México (Mexican Navy)|