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| ID | Type | Description | Link |
|---|---|---|---|
| EC/IRB Number- 2021/12-14 | Other Identifier | Tepecik Training and Research Hospital |
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This observational retrospective cohort study aims to identify clinical and biochemical predictors of response to propranolol prophylaxis in pediatric migraine. A total of 178 children diagnosed with migraine between 2021 and 2023 were evaluated based on headache-related disability (PedMIDAS) and pain severity (VAS). Patients were treated either with behavioral therapy or propranolol (1-3 mg/kg/day) for 3 months.
Migraine is a common and disabling neurological condition in the pediatric population, often requiring prophylactic treatment to reduce attack frequency and improve quality of life. Propranolol is frequently prescribed for pediatric migraine prevention; however, treatment response varies considerably among individuals. Understanding the clinical and biochemical factors that predict treatment efficacy could enhance individualized care and reduce unnecessary medication use.
This retrospective cohort study evaluated 178 children diagnosed with pediatric migraine between January 2021 and December 2023 at a tertiary neurology outpatient clinic. All participants were assessed using the Pediatric Migraine Disability Assessment Scale (PedMIDAS) and Visual Analog Scale (VAS) before and after treatment. Patients received either behavioral therapy or oral propranolol (1-3 mg/kg/day) for a duration of 3 months, based on clinical indication and family preference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Behavioral therapy group |
| |
| Group 2 | Propranolol group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral therapy | Behavioral | Patients in PedMIDAS stage 1-2 (score ≤ 30) received behavioral therapy including lifestyle counseling, stress management techniques, sleep hygiene education, and individualized headache triggers review. Additionally, each patient was provided with a headache report card to self-monitor symptoms, triggers, and medication use over a 3-month period. |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Migraine Disability Assessment Scale (PedMIDAS) Score | The primary outcome is the change in PedMIDAS score from baseline to 3 months after treatment. PedMIDAS is a validated questionnaire that quantifies migraine-related disability in children and adolescents. A greater reduction indicates improved clinical response. | Baseline to 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Pain Scores | VAS pain scores range from 0 (no pain) to 10 (worst imaginable pain). The change in VAS score after 3 months of treatment reflects the patient's subjective pain improvement. | Baseline to 3 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consisted of pediatric patients aged [2-19] who were diagnosed with primary headache disorders, specifically migraine, according to the International Classification of Headache Disorders, 3rd edition (ICHD-3). Participants were evaluated and followed at the pediatric neurology outpatient clinic of a tertiary care hospital between January 2021 and December 2023. Patients with confirmed comorbid conditions (e.g., anxiety, benign paroxysmal vertigo, essential tremor) and/or vitamin deficiencies were included to assess the impact of these factors on treatment response. Those with secondary headache, neurological disorders, or incomplete records were excluded.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kayseri University | Kayseri | 38130 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D015928 | Cognitive Behavioral Therapy |
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
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| Propranolol | Drug | Patients in PedMIDAS stage 3-4 (score > 30) received oral propranolol treatment at a dose of 1-3 mg/kg/day, adjusted by weight and tolerance, for a total of 3 months. The medication was prescribed and monitored by a pediatric neurologist. Patients were followed with routine check-ups and adverse effects were recorded. |
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| D009422 | Nervous System Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| 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 |