This one blinded randomized controlled trial is planned to investigate the effect of intravenous propofol versus sodium valproate on acute migraine headache in patients who refer to emergency ward of Farshchian hospital. After signing informed consent, the eligible patients will be assigned randomly into two different groups, propofol (P) versus sodium valproate (V). The P group will receive a single dose of 200 mg propofol mixed with 500 ml normal saline within 45 minute. The V group will receive 500 mg sodium valproate mixed with 500 ml normal saline within 45 minute. Severity of pain assists with Numerical Rating Scale (NRS) before administration of drugs and each 15 min during drug infusion and each 30 min for two hours. Also, in patient with reduced severity of pain we will assist pain severity for next 24 and 48 hours through the telephone.
General information
Acronym
ASA: American Society of Anesthesiologists; NRS: Numerical Rating scale
IRCT registration information
IRCT registration number:IRCT2012121911822N1
Registration date:2013-04-04, 1392/01/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-04, 1392/01/15
Registrant information
Name
Behrooz Karkhanei
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0574
Email address
karkhanei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of Research and Technology, Hamadan University of Medical Science
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-09-06, 1392/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous infusion of propofol and sodium valproate on alleviation of acute migraine
Public title
Comparison of intravenous infusion of propofol and sodium valproate on alleviation of acute migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Acute migraine attack; 20 to 50 years; ASA≤II
Exclusion criteria: Patient refuse; Allergy to propofol or sodium valproate; Allergy to egg or soya
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
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
Local Human Subject Review Board
Street address
Hamadan University Of Medical Sciences, Shaheed Famideh Street
City
Hamadan
Postal code
6517838695
Approval date
2013-02-24, 1391/12/06
Ethics committee reference number
D/P/16/35/9/4165
Health conditions studied
1
Description of health condition studied
Migraine Headache
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Headache severity
Timepoint
Before administration of drugs and each 15 min during drug infusion and each 30 min for two hours. Also, in patient with reduced severity of pain we will assist pain severity for next 24 and 48 hours.
Method of measurement
Numerical Rating Scale (NRS), 0 for without pain and 10 for worst pain
Secondary outcomes
1
Description
Any side effect such as allergy
Timepoint
Each 15 min during drug infusion and each 30 min for two hours. Also, in patient with reduced pain for next 24 and 48 hours through the telephone.
Method of measurement
Ask from patient according to Questionnaire
Intervention groups
1
Description
َA single dose of 200 mg propofol mixed with 500 ml normal saline within 45 minute.
Category
Treatment - Drugs
2
Description
A single dose 500 mg sodium valproate mixed with 500 ml normal saline within 45 minute.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
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
Vice chancellor of Research and Technology, Hamadan University of Medical Science
Full name of responsible person
Ahmad Tavilani
Street address
Vice chancellor of Research and Technology, Hamadan University of Medical Sciences, Shaheed Fahmideh Street
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research and Technology, Hamadan University of Medical Science
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
Hamadan University of Medical Sciences
Full name of responsible person
Behrooz Karkhanei
Position
MD. Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Medicine Faculty, Hamadan University of Medical Sciences, Shaheed Fahmideh
City
Hamadan
Postal code
Phone
+98 81 1838 0574
Fax
Email
karkhanei@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Behrooz Karkhanei
Position
MD. Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Medicine Faculty, Hamadan University of Medical Sciences, Shaheed Fahmideh
City
Hamadan
Postal code
Phone
+98 81 1838 0574
Fax
Email
karkhanei@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Zohreh Kheradmand
Position
Medical student
Other areas of specialty/work
Street address
Medicine Faculty, Hamadan University of Medical Sciences, Shaheed Fahmideh Street
City
Hamadan
Postal code
Phone
Fax
Email
kheradmand.zohreh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)