The effect of intravenous sodium valproate versus dexamethasone on headache relief in patients with acute migraine headache: a double blinded randomized clinical trial
Objectives: To investigate the effect of intravenous sodium valproate versus dexamethasone on acute migraine headache Design: Double blinded randomized controlled trial Setting and conduct: Patients who will refer to emergency ward of Beasat and Farshchian hospitals during study period Participants including major eligibility criteria: age of 18 to 65 years; history of having migraine for at least one year; severity of headache equal to or greater than 5 VAS Intervention: A single dose of 400 mg sodium valproate plus 50 mL saline normal solution within 15 min intravenously, versus a single dose of 16 mg dexamethasone plus 50 mL saline normal solution within 15 min intravenously Main outcome measures: Severity of headache using VAS scale will be measured at baseline, one half and two hours later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202199014N1
Registration date:2012-03-24, 1391/01/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-24, 1391/01/05
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-04-21, 1391/02/02
Expected recruitment end date
2012-10-23, 1391/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous sodium valproate versus dexamethasone on headache relief in patients with acute migraine headache: a double blinded randomized clinical trial
Public title
The effect of intravenous sodium valproate versus dexamethasone on acute migraine headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 65 years; history of having migraine for at least one year; severity of headache equal to or greater than 5 VAS
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Local Human Subject Review board of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Approval date
2012-02-27, 1390/12/08
Ethics committee reference number
D/P/16/35/9/4452
Health conditions studied
1
Description of health condition studied
Acute migraine headache
ICD-10 code
G43
ICD-10 code description
Migraine with or without aura
Primary outcomes
1
Description
Severity of headache
Timepoint
At baseline and then 0.5 hour and 2 hours later
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Any side effect such as allergy
Timepoint
0.5 hour and 2 hours later
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention 1: A single dose of 400 mg sodium valproate plus 50 mL saline normal solution within 15 min intravenously.
Category
Treatment - Drugs
2
Description
Intervention 2: A single dose of 16 mg dexamethasone plus 50 mL saline normal solution within 15 min intravenously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat and Farshchian Hospitals
Full name of responsible person
Shahir Mazaheri
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vic-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Ahmad Tavilani
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Grant name
از محل يك درصد بودجه طرحهاي تحقيقاتي دانشگاه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Research Center for Health Sciences, Department of Epidemiology & Biostatistics
Full name of responsible person
Jalal Poorolajal
Position
MD, PhD, Assistant Professor of Epidemiology
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.