ondansetron for dehydratation in childre

Phase 1

• Conditions: Vomiting; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-002601-19-ES
• Lead Sponsor: Basque Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-10
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 220

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified