Vomiting
Conditions
Interventions
Trade Name: Ondansetron Normon
Pharmaceutical Form: Tablet
INN or Proposed INN: Ondansetron
CAS Number: 99614-02-5
Other descriptive nam
Sponsors
Basque Health Service
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Presence of two vomits during the last 4 h - Failed oral rehydration tolerance - Informed consent signature by the parents or legal guardian - Vomits or acute gastroenteritis with vomits diagnosis -Pacients with weight higher or equal to 15 Kg Are the trial subjects under 18? yes Number of subjects for this age range: 220 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Consciousness alteration. - Acute abdomen suspicion (appendicitis…). - Obstruction symptoms suspicion. - Previous known digestive illnesses (Chron disease…) - Food poisoning suspicion. - Previous known pharmacy allergy. - Severe grade of dehydration. - Bilious vomiting. - Previous abdominal surgery. - Previous illness who will affect the patient hydration. - Hospitalization or intravenous rehydration is need.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the percentage of the children who revisit the physician during the same episode of vomiting.;Primary end point(s): Re-visits the physician during the same episode of vomiting.;Timepoint(s) of evaluation of this end point: Within 24, 48 hours and 7 days after de emrgency visit.; Secondary Objective: 1. To compare the percentage of children who vomit during 8, 24 and 48 hours after the first dose of ondansetron has been taken. 2. To compare the number of vomits provided by the parents after the first dose of ondansetron has been taken. 3. To compare the duration of the vomits in each group. 4. To compare the percentage of the children who exhibit diarrhea in each group. 5. To compare the percentage of children who present adverse effects in each group. 6. To compare the results of the children who visit a physician in the Primary Care Center due to the same episode. 7. To compare the results of the children who visit a physician in the Hospital Emergency Area due to the same episode. 8. To compare the percentage of children who need intravenous rehydration. 9. To compare the percentage of children who need hospitalization during the same period. 10. To compare satisfaction of the parents during the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Vomiting. Sickneess/nausea. Visits anda hospitalization. Intravenous rehydration. Adverse effects. parents satisfaction with the treatment. ;Timepoint(s) of evaluation of this end point: Within 8, 24 , 48 hours anda 7 days after de emrgency visit. | — |
Countries
Spain
Contacts
Public ContactLizar Aguirre
Basque Health Service
Outcome results
None listed