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Aliment. Pharmacol. Ther. · Feb 1997
Randomized Controlled Trial Comparative Study Clinical TrialAntiemetic activity of ondansetron in acute gastroenteritis.
- L X Cubeddu, L M Trujillo, I Talmaciu, V Gonzalez, J Guariguata, J Seijas, I A Miller, and W Paska.
- Department of Pharmacology, School of Pharmacy, Central University of Venezuela, Caracas.
- Aliment. Pharmacol. Ther. 1997 Feb 1;11(1):185-91.
BackgroundThe mechanism of nausea and vomiting associated with gastroenteritis is unknown. The role of 5-HT3 receptors in emesis associated with gastroenteritis was investigated in paediatric patients.MethodsA randomized, double-blind, placebo-controlled, parallel-group study was conducted in three groups of 12 patients each, receiving either a single i.v. dose of ondansetron (0.3 mg/kg), metoclopramide (0.3 mg/kg) or placebo (sterile saline). Food was restricted and oral rehydration was administered for 4 h.ResultsDuring 0-24 h, the number of emetic episodes experienced was significantly greater (P = 0.048) with placebo (mean = 5) than ondansetron (mean = 2) and the proportion of patients experiencing no emesis was significantly greater (P = 0.039) with ondansetron (58%) than placebo (17%). A numerical difference, in favour of ondansetron, was observed between ondansetron and metoclopramide groups for both of the above parameters. Fewer treatment failures were observed with ondansetron (17%) than placebo (33%) and metoclopramide (42 %). More diarrheal episodes were observed in the groups receiving anti-emetic treatment. All three treatments were well tolerated.ConclusionsOndansetron, a 5HT3 receptor antagonist, was significantly superior to placebo in preventing emesis associated with acute gastroenteritis, in paediatric patients. Therefore, serotonin, acting through 5HT3 receptors, may play a role in this form of emesis.
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