Status:
COMPLETED
Ondansetron Administration to WELL Children With Gastroenteritis Associated Vomiting in EDs in Pakistan
Lead Sponsor:
Dr. Stephen Freedman
Collaborating Sponsors:
Thrasher Research Fund
Bill and Melinda Gates Foundation
Conditions:
Dehydration
Gastroenteritis
Eligibility:
All Genders
6-59 years
Phase:
PHASE4
Brief 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) rehydrat...
Detailed Description
Gastroenteritis remains one of the most common causes of morbidity and mortality in children \<5 years of age worldwide. A critical factor in the reduction in mortality over the past 30 years has been...
Eligibility Criteria
Inclusion
- Age 6 - 59 months (0.5 - 5 years)
- Symptoms consistent with gastroenteritis (must have a \& b)
- 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).
- 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 NO dehydration (NO=not enough signs to classify as some or severe dehydration)
Exclusion
- Weight \<8 kg
- Vomiting or diarrhea for \> 7 days
- Malnutrition: The World Health Organization (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
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2017
Estimated Enrollment :
625 Patients enrolled
Trial Details
Trial ID
NCT01870635
Start Date
May 1 2014
End Date
February 3 2017
Last Update
March 2 2018
Active Locations (2)
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1
Aga Khan University Hospital
Karachi, Pakistan
2
Aga Khan Hospital for Women and Children (AKHWC)
Kharadar, Karachi, Pakistan