Health Condition 1: E860- Dehydration Health Condition 2: R197- Diarrhea, unspecified Health Condition 3: R111- Vomiting
Conditions
Interventions
Intervention1: Intramuscular Ondansetron: 0.2 mg/kg, single dose, via intramuscular route
Control Intervention1: Oral Ondansetron: 0.2mg/kg (0.5ml/kg of 2mg/5ml ondansetron syrup), single dose, via o
Sponsors
University College of Medical Sciences and GTB Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Children with acute diarrhea (duration <14 days) with some dehydration as per WHO criteria, and at least two reported episodes of non-bilious, non-bloody, vomiting within last 6 hours
Exclusion criteria
Exclusion criteria: 1. Severe malnutrition (weight for length / height 2. Conditions associated with edema (e.g. nephrotic syndrome, congestive heart failure) 3. Known hypersensitivity to ondansetron 4. Known cardiac disorder or previous history of arrhythmias 5. Unconscious or Convulsing 6. Presence of paralytic ileus or intestinal obstruction as evaluated clinically. 7. Children who have received any antiemetic or intravenous fluids within 24 hours before enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failure of ORT (defined as persistence of signs of some dehydration after 4 hours of ORT or need for intravenous fluids at any time during oral rehydration therapy)Timepoint: 4 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Need for unscheduled intravenous fluids 2. Amount of ORS (mL/kg) ingested after 4 hours 3. Frequency of vomiting episodes in each group 4. Adverse effects 5. Caregiver satisfaction measured on a Likert scale Timepoint: 4 hours | — |
Countries
India
Contacts
Public ContactDr Dheeraj Shah
University College of Medical Sciences and GTB Hospital, Delhi
Outcome results
None listed