Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE December 19, 2012
First Posted Date  ICMJE December 25, 2012
Results First Submitted Date  ICMJE May 11, 2016
Results First Posted Date  ICMJE March 25, 2020
Last Update Posted Date March 25, 2020
Study Start Date  ICMJE January 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acetaminophen and Ibuprofen With and Without Magnesium and Primary Migraine in Childhood
Official Title  ICMJE The Effects of Acetaminophen and Ibuprofen With and Without Magnesium in the Treatment of Primary Migraine in Childhood
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).

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • 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
  • Drug: acetaminophen 15 mg/kg
    Acetaminophen 15 mg/kg oral single dose
    Other Name: acetaminophen
Study Arms  ICMJE
  • Active Comparator: Acetaminophen
    Acetaminophen 15 mg/kg oral single dose (n=40)
    Intervention: Drug: acetaminophen 15 mg/kg
  • Active Comparator: Ibuprofen
    Ibuprofen 10 mg/kg oral single dose (n=40)
    Intervention: Drug: Ibuprofen 10 mg/kg
  • Experimental: Acetaminophen + magnesium 400 mg
    Acetaminophen 15 mg/kg oral single dose (n=40) + magnesium 400 mg
    Interventions:
    • Drug: Magnesium 400Mg
    • Drug: acetaminophen 15 mg/kg
  • Experimental: ibuprofen + magnesium 400 mg
    ibuprofen 10 mg/kg oral single dose (n=40) + magnesium 400 mg
    Interventions:
    • Drug: Magnesium 400Mg
    • Drug: Ibuprofen 10 mg/kg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2012)
160
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
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.
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01756209
Other Study ID Numbers  ICMJE Migraine2010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Luca Gallelli, University of Catanzaro
Study Sponsor  ICMJE University of Catanzaro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francesco Peltrone, MD Pugliese Ciaccio Hospital
PRS Account University of Catanzaro
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP