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Comorbidity-Based Propranolol Use in Pediatric Migraine

K

Kayseri University

Status

Completed

Conditions

Pediatric Migraine
Vitamin D Deficiency
Migraine Disorders, Brain

Treatments

Drug: Propranolol
Behavioral: Behavioral therapy

Study type

Observational

Funder types

Other

Identifiers

NCT07103031
KayseriUniversity12
EC/IRB Number- 2021/12-14 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

488 patients

Sex

All

Ages

2 to 19 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children aged 0-20 years
  • Diagnosed with primary headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)
  • Clinical and/or neurological evaluation consistent with primary headache
  • Completed baseline PedMIDAS and VAS assessments
  • Available for 3-month follow-up after initiation of treatment

Exclusion criteria

  • Diagnosis of secondary headache, based on clinical history, family history, neurological examination, or laboratory/imaging findings
  • Failure to meet ICHD-3 diagnostic criteria for primary headache
  • Presence of structural brain lesions or other neurological disorders
  • Chronic systemic illness or current use of other migraine prophylactic medications
  • Incomplete data or loss to follow-up within the 3-month period

Trial design

488 participants in 2 patient groups

Group 1
Description:
Behavioral therapy group
Treatment:
Behavioral: Behavioral therapy
Group 2
Description:
Propranolol group
Treatment:
Drug: Propranolol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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