Health Condition 1: null- Acute diarrhea Health Condition 2: A09- Infectious gastroenteritis and colitis, unspecified
Conditions
Interventions
Intervention1: ondansetron: 0.2 mg/Kg (0.5 mL/kg) single dose orally, syrup form
Control Intervention1: Placebo: 0.5 mL/kg identicaly looking and packaged inert liquid
Sponsors
DR DHEERAJ SHAH
Eligibility
Inclusion criteria
Inclusion criteria: Clinical diagnosis of acute diarrhea (Duration less than 14 days) with some dehydration (WHO criteria) and at least two reported episodes of non-bilious, non-bloody vomiting within last 6 hours
Exclusion criteria
Exclusion criteria: ? Severe malnutrition (weight for length / height less than 3 SD of WHO standard or bipedal edema) ? Conditions associated with edema such as nephrotic syndrome, congestive heart failure, chronic liver disease ? Unconscious or convulsing child ? Presence of paralytic ileus as evaluated clinically
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Requirement for unscheduled intravenous fluids. 2. Failure to respond to ORT after 4 hours (Features of some dehydration persisting after 4 hours of ORT or going into severe dehydration at any time during assessment) 3. Amount of ORS intake after 4 hours. Timepoint: 4 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of rehydration correction 2. Number of vomiting episodes. 3. Adverse effects e.g. rash, headache etc. 4. Caregiver satisfaction as assessed on a Likert scale Timepoint: 4 hours | — |
Countries
India
Contacts
Public ContactDR DHEERAJ SHAH
Department of Pediatrics, University Colllege of Medical Sciences
Outcome results
None listed