Recurrent migraine headaches in children aged 5 to 15 years. Migraine without aura [common migraine] ,Migraine with aura [classical migraine]
Conditions
Interventions
Intervention 1: Group 1: Oral melatonin at a dose of 0.3 mg/kg (maximum 6 mg) once daily before bedtime for 90 days. Intervention 2: Intervention group: Oral amitriptyline at a dose of 1 mg/kg (maximu
Sponsors
Vice-Chancellor for Research, Isfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
5 Years to 15 Years
Inclusion criteria
Inclusion criteria: 1.Age between 5 and 15 years 2.Diagnosis of migraine headache (with or without aura) based on the second edition of the International Classification of Headache Disorders (ICHD-II), confirmed by a pediatric neurologist 3.Experiencing at least one headache episode per week 4.Having moderate to severe migraine-related disability, defined as a PedMIDAS score >10 5.No use of any migraine prophylactic medications prior to enrollment in the study
Exclusion criteria
Exclusion criteria: 1.Children with secondary headaches or systemic diseases (e.g., renal or hepatic failure, cardiac, hematologic, or endocrine disorders), based on physical examination and paraclinical findings (e.g., lab tests or neuroimaging if increased intracranial pressure is suspected) 2.Children or parents unwilling to participate in the study 3.Children with a history of drug allergy 4.Children with epilepsy or complex migraine 5.Children showing severe and uncontrolled adverse effects to melatonin or amitriptyline 6.Children receiving other migraine prophylactic drugs (except melatonin or amitriptyline) 7.Children with migraine and significant psychiatric comorbidities (e.g., depression or ADHD) who use analgesics more than 4 times per week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of migraine attacks per month before and after the intervention. Timepoint: Outcome variables will be measured at baseline (before intervention) and then every two weeks during the 3-month treatment period. Method of measurement: The number of migraine attacks will be recorded daily by the parents and children in a headache diary. Additionally, headache intensity will be assessed using the Numerical Rating Scale (NRS), and headache-related disability will be evaluated by the Pediatric Migraine Disability Assessment Scale (PedMIDAS) during biweekly visits. All data will be collected and recorded by a trained research assistant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Headache Frequency. Timepoint: Every 2 weeks during the 3-month treatment period. Method of measurement: Number of headache attacks recorded daily by parents and child in a headache diary.;Headache Severity. Timepoint: Every 2 weeks at each visit. Method of measurement: Headache severity assessed using Numeric Rating Scale (NRS) or Visual Analog Scale (VAS).;Headache Disability (pedMIDAS). Timepoint: At baseline and at the end of the 3-month treatment period. Method of measurement: Disability assessed by the Pediatric Migraine Disability Assessment Score (pedMIDAS) questionnaire.;Analgesic Use. Timepoint: Throughout the treatment period. Method of measurement: Number of days the child used analgesics recorded in the diary.;Drug Side Effects. Timepoint: Every 2 weeks at each visit. Method of measurement: Side effects recorded through parent reports and clinical examinations.;Treatment Response. Timepoint: At the end of the 3-month treatment period. Method of measurement: More than 50% reduction in monthly headache frequency considered as good response. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNeda Hoseini Meshkenani
Esfahan University of Medical Sciences
Outcome results
None listed