Acetaminophen and Ibuprofen With and Without Magnesium and Primary Migraine in Childhood
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 Type:||Observational [Patient Registry]|
|Study Design:||Time Perspective: Prospective|
|Target Follow-Up Duration:||18 Months|
|Official Title:||The Effects of Acetaminophen and Ibuprofen With and Without Magnesium in the Treatment of Primary Migraine in Childhood|
- pain-relief [ Time Frame: 3 and 18 months ] [ Designated as safety issue: No ]The primary endpoint was when pain-relief took place and pain intensity differences from baseline (0 hour) to 3 hours after drug treatment. This measurement was defined as the AUC for the sum of the 2 measurements (pain relief and pain intensity difference) at each time point from 0 to 3 hours.
Biospecimen Retention: Samples With DNA
|Study Start Date:||January 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756209
|Pugliese Ciaccio Hospital|
|Catanzaro, Italy, 88100|