Ondansetron Administration to Children With Gastroenteritis, Vomiting and SOME Dehydration in EDs in Pakistan

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to determine if the administration of a single dose of oral ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in intravenous (IV) rehydration therapy in children presenting for emergency department care with some dehydration, vomiting and diarrhea in Pakistan.

SOME Dehydration is defined as 2 or more of the following signs and symptoms:

• Restlessness, irritability

• Sunken Eyes

• Drinks eagerly, thirsty

• Skin pinch goes back slowly

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Stephen Freedman; Sarah Williamson-Urquhart
• Collaborators: Aga Khan University; Bill and Melinda Gates Foundation; Thrasher Research Fund
• Treatments: Ondansetron

Criteria

Inclusion Criteria:

• Age 6 - 59 months (0.5 - 5 years)

• Symptoms consistent with gastroenteritis (must have a & b)

1. 1 episode of nonbilious, nonbloody vomiting within the 4 hours preceding triage The requirement for only 1 vomiting episode is based on prior work which similarly required 1 vomiting episode within 4 hours of triage. The later study reported a 17% absolute reduction in the use of IV rehydration. The vast majority of children seeking care and enrolled in the aforementioned study had a significantly greater number of vomiting episodes in the preceding 24 hour (mean >9 episodes).29

2. Presence of ≥ 1 episode of diarrhea during the illness We require the presence of only 1 diarrheal stool to enhance our probability of enrolling children with enteritis (as opposed to other diagnoses).

In fact, of the 8 RCTs performed using antiemetics in children with gastroenteritis in developed countries, only 1 even required the presence of any diarrhea as part of the eligibility criteria (and that study required a single diarrheal stool).

• Presence of "SOME" dehydration - 2 or more of the following signs: i. Restlessness, irritability; ii. Sunken Eyes; iii.Drinks eagerly, thirsty; iv.Skin pinch goes back slowly

Exclusion Criteria:

• Weight <8 kg

• Vomiting or diarrhea for > 7 days

• Malnutrition: The WHO definition will be employed - weight for height below -3z scores of the median WHO growth standards

• Severe dehydration (WHO criteria) or hypotension defined as a systolic blood pressure <70 mm Hg in infants 1 month to 12 months, < 70 mm Hg + (2 x age in years) in children 1-10 years, < 90 mm Hg in children ≥ 10 years

• Prior abdominal surgery (excluding hernia)

• Bilious or bloody vomitus

• Known hypersensitivity to ondansetron or any serotonin receptor antagonist

• History or family history of prolonged QT syndrome

• Taking apomorphine or any medication that is generally accepted as having a risk of causing torsades de pointes

• Patients previously enrolled in the study

• Follow-up will not be possible