Phase 4 N=160 Randomized Single-blind Treatment

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

Migraine

Bottom Line

View on ClinicalTrials.gov: NCT01756209 ↗

Enrolled (actual)

160

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Pain-relief — 5.6; 5.1; 2.25; 2.2 units on a scale*hr

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Magnesium 400Mg (Drug); Ibuprofen 10 mg/kg (Drug); acetaminophen 15 mg/kg (Drug)
Age: Pediatric, Adult · 5+ yrs
Sex: All
Sponsor: University of Catanzaro
Primary completion: Feb 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain-relief	5.6; 5.1; 2.25; 2.2	—

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).

Eligibility Criteria

Inclusion Criteria

Children with migraine without aura (MoA) diagnosed according to the criteria for pediatric age of the International Classification of Headache Disorders (IHS-2)
aged from 5 to 18 years
at least four attacks /month

Exclusion Criteria

mental retardation (IQ 95 percentiles),
liver or renal diseases,
gastrointestinal disorders such as peptic or duodenal ulcer, dyspepsia, or heartburn;
hypersensitivity to medication studies.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01756209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.