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

March 23, 2020 updated by: Luca Gallelli, University of Catanzaro

The Effects of Acetaminophen and Ibuprofen With and Without Magnesium in the Treatment of 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design The present work is a single-blind, balanced recruitment, parallel-group, single center study in outpatient children enrolled at the Pediatric Unit-Pugliese Ciaccio Hospital in Catanzaro, Italy, between January 2010 and June 2010.

This study had been approved by the Researchers Ethics Committee of the "Pugliese-Ciaccio" Hospital (protocol number 720/2010; EUDRACT NUMBER 2012-005737-36), and was conducted following the Declaration of Helsinki and the Guidelines for Good Clinical Practice criteria.

Population Children with migraine without aura (MoA) of both sexes aged from 5 to 16 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) [22].

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.

Informed written consent was obtained by parents.

Experimental protocol In a balanced recruitment study eligible outpatients with primary acute migraine were assigned to receive at pain onset: acetaminophen (15mg/kg) or ibuprofen (10mg/kg). Moreover, in order to evaluate the prophylaxis effect of magnesium in another set of experiments eligible children were assigned to receive a daily magnesium supplement (400 mg/daily) and then one single dose of acetaminophen (15mg/kg) or ibuprofen (10 mg/kg) at the time of pain (Figure 1). In this study, in agreement with the Declaration of Helsinki (1991), we did not use a placebo group.

In each group, children were assigned in accordance to age, gender in order to obtain similar groups of treatment.

In order to assess the intensity of pain, before and up to 3 hours after the administration of both drugs used in the present protocol, a non standardized ad hoc scale and a visual analogical scale (VAS) were used.

Specifically, for the pre-dose assessments, the pain intensity was measured on an arbitrarily established categoric scales in response to the question, "What is your pain level at this time?" with response choices from 0 to 3, where 0 = none; 1 = mild; 2 = moderate; and 3 = severe. In addition, a visual analogical scale (VAS) was used to assess pain severity before, during and after the treatment. Patients were asked to draw a single vertical line on the 100-mm VAS, where 0 = no pain (score 0) and 100 mm = worst pain (score 10). This scale had been previously used to measure pain in pediatric populations .

The safety on medication studies was assessed in terms of frequency and nature of adverse drug reactions (ADRs). In order to evaluate the association between ADRs and drug treatment, the Naranjo Adverse Probability Scale was applied .

Number, duration, severity of pain attacks, analgesic intake and the occurrence of ADRs were recorded in a daily diary card 1 month prior to the trial and subsequently during the entire period of the study. For each patient, follow-up sessions were planned every month after enrollment and continued for 18 months (end of the study).

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • Pugliese Ciaccio Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • ibuprofen
Experimental: Acetaminophen + magnesium 400 mg
Acetaminophen 15 mg/kg oral single dose (n=40) + magnesium 400 mg
Drug: acetaminophen 15 mg/kg
Acetaminophen 15 mg/kg oral single dose
Other Names:
  • acetaminophen
Drug: Magnesium 400Mg
magnesium 400 mg + conventional treatment
Other Names:
  • magnesium
Experimental: ibuprofen + magnesium 400 mg
ibuprofen 10 mg/kg oral single dose (n=40) + magnesium 400 mg
Drug: Ibuprofen 10 mg/kg
ibuprofen 10 mg/kg oral single dose
Other Names:
  • ibuprofen
Drug: Magnesium 400Mg
magnesium 400 mg + conventional treatment
Other Names:
  • magnesium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catanzaro

Investigators

  • Principal Investigator: Francesco Peltrone, MD, Pugliese Ciaccio Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

December 19, 2012

First Posted (Estimate)

December 25, 2012

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Migraine2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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