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Study aim: In this study, we intend to evaluate the effect of magnesium + propranolol versus placebo + propranolol in pediatrics afflicted with migraine. Design: A randomized double-blind placebo-controlled phase 3 clinical trial with parallel design. 140 patients are randomized to 2 groups and take the aforementioned medications for 3 months and complete a migraine diary. randomization is done using random table. Settings and conduct: The study is performed in Pediatrics neurology unit of Imam Reza clinic in Shiraz city, a governmental facility. eligible patients are randomized and provided with appropriate medications with identical shapes and packaging and, followed up for 3 months. studying physicians and patients are blind to the study group. Participants/Inclusion and exclusion criteria: Inclusion criteria: Children with 6-18 years of age and weights less than 90 Kg, having migraine diagnosed according to IHSC-3 criteria with at least 4 migraine attacks per month or 8 days-of-headache per month in the past month. Exclusion Criteria: Coexistence of another type of headache; having migraine headaches or using analgesics on at least 15 days per month; history of epilepsy or neurological comorbidity; mental retardation; Addiction; magnesium contraindications; propranolol contraindications; history of using migraine prophylaxis medications or magnesium supplements in the past month; history of psychiatric disorders; patient's poor medication compliance; Illiteracy of the patient and family Intervention groups: Half of the patients take Magnesium Oxide 10 mg/kg/day and another half take identical placebo; in addition, both groups also receive Propranolol 0.5 mg/kg/day. after the first visit, patients are evaluated 4 weeks and 12 weeks after the initiation. Main outcome variables: Amount of reduction in frequency of migraine attacks is the primary outcome of the study.
IRCTID: IRCT20221115056506N1
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