Objectives: Comparative assessment of intravenous caffeine citrate vs. intravenous magnesium sulfate intravenous administration efficacy in acute Migraine headaches
Inclusion criteria: Moderate to severe pain (pain score>4) in ages 18-60 year old with diagnosis of migraine headache
Exclusion criteria: History of Arrhythmia; Ischemic heart disease; Hypertension; Peptic ulcer disease; Inflammatory bowel disease; Obsessive disorder; Pregnancy; Breast feeding period; Homeostasis disorder; Renal failure; Hepatic failure; Sleep disorder
Participants: Patients with complaint of moderate to severe headache who are consist with diagnosis of common migraine according to IHS criteria without any contraindication for caffeine and magnesium
Sample size: 70 patients
Setting and conduct: Eligible patients based on study design (available sampling) after pain assessment with Visual Analog Scale (VAS) will treated with drug administration and reassessed 30min, 1hr and 2hr after. 30 mm (3 score) reduction in measured scale will be acceptable response.
Main outcome measures: Pain Score change 30 min, 1 and 2 hours after drug administration
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061315640N2
Registration date:2016-07-02, 1395/04/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-02, 1395/04/12
Registrant information
Name
Alireza Baratloo
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 0432
Email address
alirezabaratloo@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-09-21, 1395/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative assessment of Intravenous Magnesium Sulphate vs. Intravenous Caffeine in Acute Migraine Headache Presenting to the Emergency Department
Public title
Intravenous Caffeine Citrate versus Magnesium Sulphate for Pain control of Acute Migraine Headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Moderate to severe pain (pain score>4) in ages 18-60 year old; with History of at least five attacks lasts 4 to 72 hours (untreated or unsuccessfully treated) and headache has at least two of the following characteristics: Unilateral location, Pulsating quality, Moderate to severe pain intensity, Aggravation by or causing avoidance of routine physical activity; At least one of the following during headache: Nausea or vomiting (or both), Photophobia and phonophobia; Not attributable to another disorder
Exclusion criteria: History of ... Arrhythmia; Ischemic heart disease; Hypertension; Peptic ulcer disease; Inflammatory bowel disease; Obsessive disorder; Pregnancy; Breast feeding period; Homeostasis disorder; Renal failure; Hepatic failure; Sleep disorder
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comittee of Shahid Beheshti University of Medical Sciences
Street address
Vice Chancellor for Research, Shahid Beheshti University of Medical Sciences, Velenjak Street
City
Tehran
Postal code
Approval date
2014-05-26, 1393/03/05
Ethics committee reference number
IR.SBMU.MSP.REC.1395.134
Health conditions studied
1
Description of health condition studied
Common Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]
Primary outcomes
1
Description
pain
Timepoint
30 min, 1 and 2 hour after drug administration
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
1
Description
side effects
Timepoint
from starting drug administration to 2 hours after end
Method of measurement
Serial physical exam
Intervention groups
1
Description
Caffeine citrate 60 mg Intravenously/ slow infusion in 30 min (one time)
Category
Treatment - Drugs
2
Description
Magnesium sulfate 2 g Intravenously/ slow infusion in 30 min (one time)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Dr. Alireza Baratloo
Street address
Tajrish Square
City
Tehran
2
Recruitment center
Name of recruitment center
Imam Hosein Hospital
Full name of responsible person
Dr. Majid Shojaee
Street address
Shahid Madani Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fariba Tadayon
Street address
Velenjak Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?