Ondansetron Administration to Children With Gastroenteritis, Vomiting and SOME Dehydration in EDs in Pakistan (OSEP)
Dehydration, Gastroenteritis, Vomiting
About this trial
This is an interventional treatment trial for Dehydration focused on measuring Low-middle income country, Dehydration, Intravenous Rehydration, Pakistan
Eligibility Criteria
Inclusion Criteria:
- 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).29
- 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
Sites / Locations
- Aga Khan University Hospital
- Aga Khan Hospital for Women and Children (AKHWC)
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Ondansetron
Placebo (sugar pill)
4 mg oral disintegrating tablet of ondansetron Participant weight 8-15 kg = half dose (2mg) Participant weight greater than 15 kg = full dose (4mg)