Efficacy of Ondansetron on Vomiting Due to Acute Gastroenteritis in Pediatric During Winter (Ondangapi)
Vomiting, Gastroenteritis
About this trial
This is an interventional treatment trial for Vomiting focused on measuring gastroenteritis, pediatrics, vomiting
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 6 months and ≤ 15 years
- Children who had more than 3 non bilious vomiting and bloodless within 12 hours before emergency department visit
- Children whose parents agree to be contacted by phone
- Completion of a medical examination (to communicate results to the patient)
- Informed consent and written / holder (s) of parental authority (s) present
Exclusion Criteria:
- Children with a congenital long QT (ECG prior to inclusion required)
- Children with and / or current symptomatic cardiovascular
- Children with a shock
- Children with a concomitant surgical pathology
- Notion of head trauma within 3 days before the emergency department visit
- Suspicion of intracranial hypertension (intracranial hypertension)
- Children who underwent surgery within 14 days before the emergency department visit
- Suspected acute can be alone responsible for vomiting, such as: discovery of diabetes, acute adrenal insufficiency, including acute neurological acute meningitis, acute respiratory illness with cough emetogenic acute otitis media, acute pyelonephritis, .. . .
- Child tracking to one of the following chronic conditions treated:
heart o
- pulmonary
- digestive (except gastroesophageal reflux)
- kidney
- hematologic (immunosuppression / SCD)
endocrine / metabolic (diabetes, adrenal insufficiency)
- Phenylketonuria
- Allergy or intolerance to ondansetron or any of the ingredients of the syrup
- Children who received treatment with an anti-emetic (Primperan ®, Motilium ®, vogalene ®) within 24 hours before emergency department visit
- Pregnancy or breastfeeding
- No affiliation to a social security scheme (beneficiary or assignee)
- Family not speaking
Sites / Locations
- Vincent Gajdos
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Ondansetron
placebo
The treatments in the form of cases numbered 1 vial of 50 ml of ondansetron 0.8 mg / ml oral solution + 5 ml syringe for oral administration. No special storage conditions ondansetron syrup.The treatment is administered orally as a single dose of 2.5 ml = 2 mg per 5 kg weight of the child, not to exceed a maximum dose of 10mg. A second outlet, at the same dose, is restored if the child vomits within 15 minutes after the first administration.
The treatments in the form of cases numbered 1 vial of 50 ml of placebo 0.8 mg / ml oral solution + 5 ml syringe for oral administration. No special storage conditions placebo syrup.The treatment is administered orally as a single dose of 2.5 ml = 2 mg per 5 kg weight of the child, not to exceed a maximum dose of 10mg. A second outlet, at the same dose, is restored if the child vomits within 15 minutes after the first administration.