A study to compare injection and oral formulation of a drug ondansetron to manage children suffering from diarrhea and vomiting
Not Applicable
Completed
- Conditions
- Health Condition 1: E860- DehydrationHealth Condition 2: R197- Diarrhea, unspecifiedHealth Condition 3: R111- Vomiting
- Registration Number
- CTRI/2020/01/023082
- Lead Sponsor
- niversity College of Medical Sciences and GTB Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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
1. Severe malnutrition (weight for length / height <â??3 SD of WHO standard)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method