At a glance
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The Effects of Acetaminophen and Ibuprofen With and Without Magnesium in the Treatment of Primary Migraine in Childhood
In Brief
A Phase 4 clinical trial evaluating Magnesium 400Mg, Ibuprofen 10 mg/kg, and 1 other intervention for Migraine. Completed, enrolled 160 participants across 1 site.
Detailed Summary
Aim: The purpose of this study was to evaluate both the effects of ibuprofen and/or acetaminophen for the acute treatment of primary migraine in children in or out prophylactic treatment with magnesium. Methods: The study had been approved by the Researchers Ethics Committee of the "Pugliese-Ciaccio" Hospital (protocol number 720/2010; EUDRACT NUMBER 2012-005737-36) and the children ranging from the ages of 5 to 18 years with at least four attack/month of primary migraine were enrolled. A Visual Analogical Scale was used to evaluate pain intensity at the moment of admission to the study (start of the study) and every month up to 18 months later (end of the study).
Study Details
Timeline
Interventions
magnesium 400 mg + conventional treatment
ibuprofen 10 mg/kg oral single dose
Acetaminophen 15 mg/kg oral single dose