Survey of treatment with ondansetron for pediatric acute gastroenteritis

Phase 1

Recruiting

• Conditions: Acute gastroenteritis; Vomitting; D005759

• Registration Number: JPRN-jRCTs031230305
• Lead Sponsor: Kishibe Shun

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

(1) Clinically diagnosed with acute gastroenteritis
(2) The patient has vomited at least twice within 24 hours
(3) The patient has vomited at least once within 4 hours
(4) Between 6 months and 15 years of age
(5) Written consent has been obtained
(6) 7 years of age or older has received ascent written explanation whenever possible

Exclusion Criteria

(1) Patients with bilious or bloody vomiting
(2) Patient with disturbance of consciousness
(3) Patient with severe dehydration or hypoglycemia requiring rapid infusion
(4) Patients who have received antiemetic drugs within 72 hours
(5) Patients whose weight is less than 8 kg
(6) Patients with underlying disease*
(7) Patients with a history of abdominal surgery
(8) Patients with an allergy to ondansetron
(9) Pregnant women or women who may be pregnant
(10) Patients with a history of epilepsy
(11) Patients who have been previously enrolled in this study.
(12) Patients who have been judged to be inappropriate to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of cases with resolution of emesis up to 4 hours after administration