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

NCT01756209 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2020-03-25

Study results available
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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).

Conditions

Interventions

DRUG

Magnesium 400Mg

magnesium 400 mg + conventional treatment

DRUG

Ibuprofen 10 mg/kg

ibuprofen 10 mg/kg oral single dose

DRUG

acetaminophen 15 mg/kg

Acetaminophen 15 mg/kg oral single dose

Sponsors & Collaborators

  • University of Catanzaro

    lead OTHER

Principal Investigators

  • Francesco Peltrone, MD · Pugliese Ciaccio Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01756209 on ClinicalTrials.gov