Only first 10,000 results will be saved in the file.
No item is selected. Use checkboxes to select search results.
Displaying 1-1 of 1 results.
{{ selectedCountPage }} items selected on this page,{{ selectedCountPage }} item selected on this page,{{ selectedCountTotal }} item in total{{ selectedCountTotal }} items in total
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.