Ondansetron orale per la gastroenterite pediatrica nelle cure primarie: uno studio randomizzato controllato che non dà utili indicazioni
Abstract
Oral Ondansetron for Paediatric Gastroenteritis in Primary Care: A Randomized Controlled Trial with no useful indications This randomized controlled pragmatic study carried out in three continuity care centers in the Netherlands promotes the use of Ondansetron as an antiemetic for acute gastroenteritis in primary care. Unfortunately, during the study, the authors changed the primary outcome from "referral to hospital treatment" to "vomiting in the first 4 hours after randomization" due to the low enrolment of patients (only 194 children enrolled in 2 years by almost 600 primary care doctors). The new outcome chosen, although statistically significant, is of little clinical interest. Enrolled patients arrived at late evaluation, after a mean symptom duration of 2 days. An earlier use of ondansetron for acute gastroenteritis in the context of primary care might therefore be effective in reducing the need for intravenous rehydration, but further studies are needed.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 194 participants or records.
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