drugset / Trial / NCT02619201
Antiemetic Efficacy of Ondansetron Versus Metoclopramide
RandomizedParallel-groupDouble-blindTreatment
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
Timeline
- Start
- 2015-11
- Primary completion
- 2016-05
- Completion
- 2016-11
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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/
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metoclopramide | Small molecule | 0.15 mg/kg | Intravenous |
| Subject | Ondansetron | Other / unclassified | 0.15 mg/kg | Intravenous |