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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: Magnesium 400Mg
Drug: Ibuprofen 10 mg/kg
Drug: acetaminophen 15 mg/kg
Enrollment 160
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acetaminophen Ibuprofen Mg + Acetaminophen Mg + Ibuprofen
Hide Arm/Group Description Acetaminophen 15 mg/kg oral single dose Ibuprofen 10 mg/kg oral single dose Magnesium 400 mg/daily + Acetaminophen 15 mg/kg oral single dose Magnesium 400 mg/daily + Ibuprofen 10 mg/kg oral single dose
Period Title: Overall Study
Started 40 40 40 40
Completed 40 40 40 40
Not Completed 0 0 0 0
Arm/Group Title Acetaminophen Ibuprofen Mg + Acetaminophen Mg + Ibuprofen Total
Hide Arm/Group Description Acetaminophen 15 mg/kg oral single dose Ibuprofen 10 mg/kg oral single dose Magnesium 400 mg/daily + Acetaminophen 15 mg/kg oral single dose Magnesium 400 mg/daily + Ibuprofen 10 mg/kg oral single dose Total of all reporting groups
Overall Number of Baseline Participants 40 40 40 40 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 40 participants 160 participants
<=18 years
40
 100.0%
40
 100.0%
40
 100.0%
40
 100.0%
160
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 40 participants 160 participants
Female
20
  50.0%
20
  50.0%
20
  50.0%
20
  50.0%
80
  50.0%
Male
20
  50.0%
20
  50.0%
20
  50.0%
20
  50.0%
80
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 40 participants 40 participants 40 participants 40 participants 160 participants
40 40 40 40 160
pain visual analog scale (range 0 (better) -100 (worse) mm)  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 40 participants 40 participants 40 participants 40 participants 160 participants
6.95  (2.9) 6.55  (2.85) 7.57  (2.55) 7.35  (2.93) 7.11  (2.81)
1.Primary Outcome
Title Pain-relief
Hide Description

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)

Time Frame 3 and 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Ibuprofen Mg + Acetaminophen Mg + Ibuprofen
Hide Arm/Group Description:
Acetaminophen 15 mg/kg oral single dose
Ibuprofen 10 mg/kg oral single dose
Magnesium 400 mg/daily + Acetaminophen 15 mg/kg oral single dose
Magnesium 400 mg/daily + Ibuprofen 10 mg/kg oral single dose
Overall Number of Participants Analyzed 40 40 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale*hr
5.6  (0.5) 5.1  (0.6) 2.25  (0.3) 2.2  (0.4)
Time Frame [Not Specified]
Adverse Event Reporting Description adverse events were collected in the clinical diary of each patient
 
Arm/Group Title Acetaminophen Ibuprofen Mg + Acetaminophen Mg + Ibuprofen
Hide Arm/Group Description Acetaminophen 15 mg/kg oral single dose Ibuprofen 10 mg/kg oral single dose Magnesium 400 mg/daily + Acetaminophen 15 mg/kg oral single dose Magnesium 400 mg/daily + Ibuprofen 10 mg/kg oral single dose
All-Cause Mortality
Acetaminophen Ibuprofen Mg + Acetaminophen Mg + Ibuprofen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%) 
Hide Serious Adverse Events
Acetaminophen Ibuprofen Mg + Acetaminophen Mg + Ibuprofen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acetaminophen Ibuprofen Mg + Acetaminophen Mg + Ibuprofen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Francesco Peltrone, Responsible of clinical trial
Organization: Pugliese Hospital of Catanzaro
Phone: +.39 0961 7123222
EMail: gallelli@unicz.it
Layout table for additonal information
Responsible Party: Luca Gallelli, University of Catanzaro
ClinicalTrials.gov Identifier: NCT01756209    
Other Study ID Numbers: Migraine2010
First Submitted: December 19, 2012
First Posted: December 25, 2012
Results First Submitted: May 11, 2016
Results First Posted: March 25, 2020
Last Update Posted: March 25, 2020