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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01756209
Recruitment Status : Completed
First Posted : December 25, 2012
Last Update Posted : December 25, 2012
Information provided by (Responsible Party):
Luca Gallelli, University of Cantanzaro

Brief 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).

Condition or disease

Study Type : Observational [Patient Registry]
Actual Enrollment : 160 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Primary Outcome Measures :
  1. pain-relief [ Time Frame: 3 and 18 months ]
    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
whole blood

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
we peformed a single blind study in outpatient children enrolled at the Pediatric Unit-Pugliese Ciaccio Hospital in Catanzaro

Inclusion Criteria:

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

Exclusion Criteria:

Exclusion criteria were the following: mental retardation (IQ <70), genetic syndromes (e.g., Down syndrome, Prader-Willi syndrome, fragile X syndrome), hypothyroidism, psychiatric disorders (i.e.: schizophrenia, mood disorders, ADHD), neuromuscular disorders, epilepsy, obesity (BMI>95 percentiles), liver or renal diseases, gastrointestinal disorders such as peptic or duodenal ulcer, dyspepsia, or heartburn; hypersensitivity to medication studies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01756209

Pugliese Ciaccio Hospital
Catanzaro, Italy, 88100
Sponsors and Collaborators
University of Cantanzaro

Additional Information:

Responsible Party: Luca Gallelli, MD, PhD, University of Cantanzaro Identifier: NCT01756209     History of Changes
Other Study ID Numbers: Migraine2010
First Posted: December 25, 2012    Key Record Dates
Last Update Posted: December 25, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action