drugset / Trial / NCT01756209

Acetaminophen and Ibuprofen With and Without Magnesium and Primary Migraine in Childhood

NCT01756209

Phase 4 Completed 160 enrolled University of Catanzaro
RandomizedParallel-groupSingle-blindTreatment

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).

Timeline

Start
2010-01
Primary completion
2012-02
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 15 mg/kg Oral
Subject Ibuprofen Small molecule 10 mg/kg Oral
Subject Magnesium Sulfate Other / unclassified 400 mg Oral

Indications