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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.
 
ClinicalTrials.gov Identifier: NCT01756209
Recruitment Status : Completed
First Posted : December 25, 2012
Results First Posted : March 25, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Luca Gallelli, University of Catanzaro

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 Intervention/treatment Phase
Migraine Drug: Magnesium 400Mg Drug: Ibuprofen 10 mg/kg Drug: acetaminophen 15 mg/kg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: Acetaminophen
Acetaminophen 15 mg/kg oral single dose (n=40)
Drug: acetaminophen 15 mg/kg
Acetaminophen 15 mg/kg oral single dose
Other Name: acetaminophen

Active Comparator: Ibuprofen
Ibuprofen 10 mg/kg oral single dose (n=40)
Drug: Ibuprofen 10 mg/kg
ibuprofen 10 mg/kg oral single dose
Other Name: ibuprofen

Experimental: Acetaminophen + magnesium 400 mg
Acetaminophen 15 mg/kg oral single dose (n=40) + magnesium 400 mg
Drug: Magnesium 400Mg
magnesium 400 mg + conventional treatment
Other Name: magnesium

Drug: acetaminophen 15 mg/kg
Acetaminophen 15 mg/kg oral single dose
Other Name: acetaminophen

Experimental: ibuprofen + magnesium 400 mg
ibuprofen 10 mg/kg oral single dose (n=40) + magnesium 400 mg
Drug: Magnesium 400Mg
magnesium 400 mg + conventional treatment
Other Name: magnesium

Drug: Ibuprofen 10 mg/kg
ibuprofen 10 mg/kg oral single dose
Other Name: ibuprofen




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.

    Pain was measured using the vas analogue scale (range 0-10, where 0 = no pain (score 0) and 100 mm = worst pain (score 10)




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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   In each group, children were assigned in accordance to age and gender in order to obtain similar groups of treatment.
Accepts Healthy Volunteers:   No
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 <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 ClinicalTrials.gov identifier (NCT number): NCT01756209


Locations
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Italy
Pugliese Ciaccio Hospital
Catanzaro, Italy, 88100
Sponsors and Collaborators
University of Catanzaro
Investigators
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Principal Investigator: Francesco Peltrone, MD Pugliese Ciaccio Hospital
Additional Information:

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Responsible Party: Luca Gallelli, MD, PhD, University of Catanzaro
ClinicalTrials.gov Identifier: NCT01756209    
Other Study ID Numbers: Migraine2010
First Posted: December 25, 2012    Key Record Dates
Results First Posted: March 25, 2020
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action