Evaluation of efficacy of add-on oral ibuprofen in children with tuberculous meningitis aged 1 month - 18 years
- Conditions
- Health Condition 1: A170- Tuberculous meningitis
- Registration Number
- CTRI/2023/04/051721
- Lead Sponsor
- AIIMS Rishikesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Presenting to department of pediatrics, AIIMS Rishikesh with a diagnosis of TB meningitis as per Maraiâ??s criteria and parents willing to comply with the study protocol and follow up
1. Preexisting major chronic systemic illness including cardiovascular, respiratory, gastrointestinal system or chronic renal disease
2. Preexisting developmental delay or intellectual disability
3. Already started on ATT for >2 weeks before presenting to our center
4. Caregivers not giving informed consent
5. History of allergy to ibuprofen previously
6. Deranged RFT (serum urea, creatinine or blood urea-nitrogen
7. Total platelet count < 50,000/ul
8. HIV positivity
9. Children in whom ibuprofen canâ??t be administered orally or through nasogastric tube within 72 hours of presenting to our institute due to clinical contraindications
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in FSS scale score at 4 weeks as compared to baseline in both groupsTimepoint: Change in FSS scale score at 4 weeks as compared to baseline in both groups
- Secondary Outcome Measures
Name Time Method 1. Change in FSS score at 12 weeks as compared to baseline <br/ ><br>2. Change in PCPC score at 4 and 12 weeks as compared to baseline <br/ ><br>3. Change in radiological severity score at 12 weeks as compared to baseline <br/ ><br>4. Mortality at 4 and 12 weeks in both arms <br/ ><br>5. Duration of hospitalization in both arms <br/ ><br>6. Number of patients with paradoxical reaction within 12 weeks <br/ ><br>7. Social quotient by VSMS at 12 weeks <br/ ><br>8. Childhood Behavioural Checklist internalizing, externalizing and total <br/ ><br>score at 12 weeksTimepoint: 4 and 12 weeks