Migraine is a chronic neurologic disorder that it defined by frequent headache, nausea, photophobia and phonophobia for duration 4-72. Sodium valproate has been shown to have both central and peripheral that may have relevance in its ant migraine effects. In the most of studies high dose dexamethasone and valproate are used for treatment of migraine. In this study we will use low dose drugs. Ninety patients, aged 15 to 65 years, presenting with typical migraine according to IHS criteria that admit at Booali hospital were enrolled. This study is prospective randomized double blind clinical trials. Participants are in two group A and B. a group get amp. Dexamethasone 8 mg and another group get Depakine 400 mg intravenous slowly. For assessing severity of headache used from grading scale. Pain, photophobia, phonophobia and vomiting recorded at 0.5,1, 3, 6, 24 hours after injection. Inclusion criteria: age (15-65); acute migraine headache according to criteria HIS; duration: lower than 48 hours; a history of migraine headache from 6 month ago; not consumption NSAID from 24 hours ago and valproate Na as prophylaxis from 2 weeks ago. Exclusion criteria: pregnancy; breastfeeding; fever; allergy to drug. Peptic ulcer; GIB from 1 year ago; diabetes and liver disorder and urea cycle defect.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014022116666N1
Registration date:2014-06-22, 1393/04/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-22, 1393/04/01
Registrant information
Name
Narges Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 6275
Email address
n.karimi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sicences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of single dose sodium valproate (Depakine) versus Dexamethasone Intravenously for treatment of acute migraine headache
Public title
Comparison of single dose sodium valproate versus Dexamethasone Intravenously for treatment of acute migraine headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 15-65 years old; acute migraine headache according to criteria IHS; duration lower than 48 hours; history of migraine headache from 6 month ago; no consumption NSAID from 24 hours ago and valproate Na as prophylaxis from 2 weeks ago. Exclusion criteria: pregnancy; breastfeeding; fever; allergy to drugs; peptic ulcer, GIB from 1 year ago; diabetes melitus and liver disorder and urea cycle defect.
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Jooybar three way, Valiasr blv.
City
Sari
Postal code
Approval date
2014-03-05, 1392/12/14
Ethics committee reference number
565
Health conditions studied
1
Description of health condition studied
Migraine headache
ICD-10 code
G43.9
ICD-10 code description
Migraine, unspecified
Primary outcomes
1
Description
Headache severity
Timepoint
30 minutes, 1, 3, 6 and 24 hours after intervention
Method of measurement
Grading 1-4 and qualitative
Secondary outcomes
1
Description
Photophobia
Timepoint
1, 3, 6, 24 and 72 hours after intervention
Method of measurement
Questionnaire
2
Description
Vomiting
Timepoint
1, 3, 6, 24 and 72 hours after intervention
Method of measurement
Questionnaire
3
Description
phonophobia
Timepoint
1,3,6,24,72 hours
Method of measurement
questionnaire
Intervention groups
1
Description
Control group: amp dexamethasome 8 mg interavenously