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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flunarizine group | Experimental | Patients will be receiving flunarizine beginning with 5 mg at bedtime and increasing it to 10 mg at bedtime after 1 month, over a 3-month treatment period. |
|
| Propranolol group | Experimental | Patients will be given propranolol beginning with 10 mg/24 hours and increasing at the rate of 10 mg/week to the maximum of 60 mg/24 hours over a 3-month treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flunarizine | Drug | Patients will be receiving flunarizine beginning with 5 mg at bedtime and increasing it to 10 mg at bedtime after 1 month, over a 3-month treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in migraine disability | Any reduction in migraine disability score measured by PedMIDAS will be labeled as reduction (efficacy). | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ishafaq Ahmed, FCPS | Contact | +923334957171 | quaidian245ishfaq@gmail.com | |
| Muhammad Zia-ur-Rehman, FCPS | Contact | +923334202863 | drzia81@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ishafaq Ahmed, FCPS | The Children's Hospital Lahore | Principal Investigator |
| Muhammad Zia-ur-Rehman, FCPS | The Children's Hospital Lahore | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital Lahore | Recruiting | Lahore | Punjab Province | 54600 | Pakistan |
Data can be shared on a reasonable request.
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D005444 | Flunarizine |
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D050198 | Phenoxypropanolamines |
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| Propranolol | Drug | Patient will be given propranolol beginning with 10 mg/24 hours and increase at the rate of 10 mg/week to the maximum of 60 mg/24 hour, over a 3-month treatment period. |
|
| D009422 | Nervous System Diseases |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |