drugset / Trial / NCT01756209
Acetaminophen and Ibuprofen With and Without Magnesium and Primary Migraine in Childhood
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 15 mg/kg | Oral |
| Subject | Ibuprofen | Small molecule | 10 mg/kg | Oral |
| Subject | Magnesium Sulfate | Other / unclassified | 400 mg | Oral |