Overview
Flunarizine and propranolol have demonstrated efficacy in reducing migraine frequency across age groups, though evidence in pediatric populations remains limited and inconsistent. Therefore, the current study has been planned to evaluate and compare the effectiveness of flunarizine and propranolol in reducing migraine frequency in children aged 8-15 using the Pediatric Migraine Disability Assessment Scale (PedMIDAS) score.
Description
Despite the clinical use of flunarizine and propranolol, direct comparisons between these two drugs in children are scarce. This study aims to bridge that gap by evaluating their relative effectiveness and safety as prophylactic treatments for pediatric migraine, addressing a critical unmet need in current research. Considering the routine use of both drugs in clinical practice, the findings would help clinicians to choose the more convenient drug between flunarizine and propranolol as preventive therapy for migraine in their local settings.
Eligibility
Inclusion Criteria:
- Children of any gender
- Aged 8-15 years
- Diagnosed with migraine (with/without aura) per International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria
- A history of ≥4 migraine attacks/month for the preceding 3 months
- With a PedMIDAS score ≥11 (moderate-to-severe impact)
Exclusion Criteria:
- Children with secondary headache disorders (e.g., due to infections, trauma, structural brain lesions)
- Known hypersensitivity or contraindications to flunarizine or propranolol
- Presence of cardiovascular disorders (e.g., bradycardia, heart block, hypotension, asthma)
- Non-compliance or inability to attend regular follow-ups
- Participation in another clinical trial within the last 3 months