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

• 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: University of Catanzaro
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Acetaminophen	Ibuprofen	Mg + Acetaminophen	Mg + Ibuprofen
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

Baseline Characteristics

Arm/Group Title		Acetaminophen	Ibuprofen	Mg + Acetaminophen	Mg + Ibuprofen	Total
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
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)

Outcome Measures

1. Primary Outcome

Title	Pain-relief
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen	Ibuprofen	Mg + Acetaminophen	Mg + Ibuprofen
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)

Adverse Events

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
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%)
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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr Francesco Peltrone, Responsible of clinical trial
• Organization: Pugliese Hospital of Catanzaro
• Phone: +.39 0961 7123222
• EMail: gallelli@unicz.it

• 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