Antiemetic Efficacy of Ondansetron Versus Metoclopramide

NCT02619201 | Unknown Phase 3

• 1 other identifier: HGNAE-10
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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

Conditions

Acute Gastroenteritis; Vomiting

Keywords

vomiting in children; ondansetron; metoclopramide; antiemetics

Outcome Measures

Primary Outcomes (1)

• Cumulative rate of vomiting after cessation of drug administration

  4 hours

Study Arms (2)

ondansetron

EXPERIMENTAL

An intravenous dose of ondansetron ( 0.15mg /kg / doses ) Diluted in 20 ml of saline and administer intravenously in 5 minutes

Drug: Ondansetron

metoclopramide

ACTIVE COMPARATOR

An intravenous dose of metoclopramide ( 0.15mg /kg / doses ) Diluted in 20 ml of saline and administer intravenously in 5 minutes

Drug: metoclopramide

Interventions

Ondansetron DRUG

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

Also known as: OD

ondansetron

metoclopramide DRUG

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

Also known as: MT

metoclopramide

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Previous abdominal surgery
• Suspected surgical abdominal
• Vomiting bile
• Hypersensitivity to Ondansetron and Metoclopramide

Sponsors & Collaborators

• Hospital General Naval de Alta Especialidad - Escuela Medico Naval: lead

Related Publications (10)

• Herikstad H, Yang S, Van Gilder TJ, Vugia D, Hadler J, Blake P, Deneen V, Shiferaw B, Angulo FJ. A population-based estimate of the burden of diarrhoeal illness in the United States: FoodNet, 1996-7. Epidemiol Infect. 2002 Aug;129(1):9-17. doi: 10.1017/s0950268801006628.

  PMID: 12211601 BACKGROUND

• Guarino A, Albano F, Ashkenazi S, Gendrel D, Hoekstra JH, Shamir R, Szajewska H; ESPGHAN/ESPID Evidence-Based Guidelines for the Management of Acute Gastroenteritis in Children in Europe Expert Working Group. European Society for Paediatric Gastroenterology, Hepatology, and Nutrition/European Society for Paediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe: executive summary. J Pediatr Gastroenterol Nutr. 2008 May;46(5):619-21. doi: 10.1097/MPG.0b013e31816e219e. No abstract available.

  PMID: 18493225 BACKGROUND

• Haque KN, al-Frayh A, el-Rifai R. Is it necessary to regraduate milk after acute gastroenteritis in children? Trop Geogr Med. 1983 Dec;35(4):369-73.

  PMID: 6689452 BACKGROUND

• Carter B, Fedorowicz Z. Antiemetic treatment for acute gastroenteritis in children: an updated Cochrane systematic review with meta-analysis and mixed treatment comparison in a Bayesian framework. BMJ Open. 2012 Jul 19;2(4):e000622. doi: 10.1136/bmjopen-2011-000622. Print 2012.

  PMID: 22815462 BACKGROUND

• National Collaborating Centre for Women's and Children's Health (UK). Diarrhoea and Vomiting Caused by Gastroenteritis: Diagnosis, Assessment and Management in Children Younger than 5 Years. London: RCOG Press; 2009 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK63844/

  PMID: 22132432 BACKGROUND

• Atia AN, Buchman AL. Oral rehydration solutions in non-cholera diarrhea: a review. Am J Gastroenterol. 2009 Oct;104(10):2596-604; quiz 2605. doi: 10.1038/ajg.2009.329. Epub 2009 Jun 23.

  PMID: 19550407 BACKGROUND

• Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med. 2006 Apr 20;354(16):1698-705. doi: 10.1056/NEJMoa055119.

  PMID: 16625009 BACKGROUND

• Rerksuppaphol S, Rerksuppaphol L. Randomized study of ondansetron versus domperidone in the treatment of children with acute gastroenteritis. J Clin Med Res. 2013 Dec;5(6):460-6. doi: 10.4021/jocmr1500w. Epub 2013 Oct 12.

  PMID: 24171058 BACKGROUND

• Das JK, Kumar R, Salam RA, Freedman S, Bhutta ZA. The effect of antiemetics in childhood gastroenteritis. BMC Public Health. 2013;13 Suppl 3(Suppl 3):S9. doi: 10.1186/1471-2458-13-S3-S9. Epub 2013 Sep 17.

  PMID: 24564795 BACKGROUND

• Roslund G, Hepps TS, McQuillen KK. The role of oral ondansetron in children with vomiting as a result of acute gastritis/gastroenteritis who have failed oral rehydration therapy: a randomized controlled trial. Ann Emerg Med. 2008 Jul;52(1):22-29.e6. doi: 10.1016/j.annemergmed.2007.09.010. Epub 2007 Nov 19.

  PMID: 18006189 BACKGROUND

MeSH Terms

Conditions

Vomiting

Interventions

Ondansetron; Metoclopramide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Yaneth Miranda Tecuautzin, medicine

  Secretaria de Marina-Armada de México (Mexican Navy)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaneth Miranda Tecuautzin, medicine

CONTACT

66 91 60 07 39; missin1821@hotmail.com

Jose de Jesus Gutierrez Escobedo, medicine

CONTACT

5516910741; abi2228@msn.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 2, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 2, 2015

Record last verified: 2015-10