Comparsion of effect of 1200 mg IV Sodiom Valproate and 8 mg IV Dexametazone in treatment of Severe Migrain Headache ,
Design
After approval for participating in the study, patients will be numbered from 101 to 208 sequentially (medications will be prepared by a pharmacist in uniform and uni-shape packages and will be randomized and numbered from 101 to 208). based on the numbers each package will be allocated to each patient. Medications will be infused by a nurse. This study is a double blind clinical trial with intervention and control groups. Sample size is 108 (54 in each group).
Settings and conduct
Golestan Hospital , Ahwaz ,Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria : Patients who come with : Acute migrainous headache which VAS score equal or more than 4 , Age equal or more than 18 to less or equal 58 years old and body weight equal or more than 50 to less or equal 80 kg. Exclusion criteria : Pregnancy or lactation , Presens of systemic disease( Cardiovascular ,Pulmonary ,Metabolic ,Liver &Renal insufficiency ,Cancer ,Seizure , Use of Anticoagolants & Anticonvulsants drugs . Use of any Sedative , Hypnotic drugs recently upto 4 h, Use of Ergot &Triptamin component recently to 24 h. Positive hypersensitivity to Dexamethazon & Sodiom Valproate
Intervention groups
Control group: 8 mg Dexametasone; (in 150 ml N/S during 10 mins).
Intervention group: 1200 mg Na Valproate (in 150 ml N/S during 10 mins).
Main outcome variables
Decrease of Migrainous Headache severity and related symptoms ,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180223038830N1
Registration date:2019-07-20, 1398/04/29
Registration timing:retrospective
Last update:2019-07-20, 1398/04/29
Update count:0
Registration date
2019-07-20, 1398/04/29
Registrant information
Name
Mohammadreza Dadkhahtehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3001
Email address
dadkhahtehrani.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of IV Sodiom Valproate in contrast to IV Dexametazon for treatment of patient with severe Migraine Headache
Public title
Effect Of IV Sodiom Valproate in Migraine , Effect of IV Dexametazon in Migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The chief complaint of patients is acute headache.
Positive past history of Migraine headache
Intensity of headache equal or more than four base on VAS score
Age equal or more than 18 to less or equal than 58 years old.
Body weight equal or more than 50 to less or equal than 80 kg.
Exclusion criteria:
BP more than 160/100 mmHg
SBP less than 100 mmHg
PR less than 50 /Min
Pregnancy or lactation
Presens of systemic disease( Cardiovascular ,Pulmonary ,Metabolic ,Liver &Renal insufficiency ,Cancer ,Seizure )
Use of Anticoagolant & Anticonvulsant & Antimetobolit drugs.
Use of any IV sedative drugs in 4 h. ago.
Use of Ergot &Triptamin component recently to 24 h.
Positive history of hypersensitivity to Dexamethazon & Sodiom Valproate
Age
From 18 years old to 58 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization , based on ETCETERA Version 3.26 ,Balanced randomization [module A3]
Blinding (investigator's opinion)
Double blinded
Blinding description
The research pharmacist will prepare 108 uniform and unishape boxes , which 54 those medications are 1200 mg Na Valproate ,and the rest of 54 medications are 8 mg Dexametason that will be placed into sequentially numbered from 101 to 208 , in order determined by balanced allocation of 108 subjects to groups A and B .
Patients that will be enrolled to the study , if they would have inclusion criteria and not have any exclusion criteria , who will be numberd from 101 to 208 respectively .
Placebo
Not used
Assignment
Parallel
Other design features
In this study , range of patients , body weight (50- 80 kg) is one of our parameters , so that , this has not been in any other same studies.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahwaz JondiShapour University of Medical Sciences
Street address
Farvardin St.
City
َAhwaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2017-12-19, 1396/09/28
Ethics committee reference number
IR.AJUMS.REC.1396.718
Health conditions studied
1
Description of health condition studied
Migraine without aura(common migraine)
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura
2
Description of health condition studied
Migraine with aura ( classic migraine )
ICD-10 code
G43.1
ICD-10 code description
Migraine with aura
Primary outcomes
1
Description
Decrease of Migrainuos Headache severity and related symptoms,
Timepoint
0.5 , 1 , 2 hour after use of medication,
Method of measurement
VAS score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sodiom Valproate (Depakine), manufactured by Sanofi S.P.A./Italy , 1200 mg in 250 cc Normal Salin , administerd intravenously over 15 minutes for the patients.
Category
Treatment - Drugs
2
Description
Control group: Dexamethasone ,manufactured by Iran Hormone Pharmaceuticals , 8 mg in 250 cc Normal Salin ,administerd intravenouslyover 15 minutes for the patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital , Ahwaz
Full name of responsible person
Mohammad Reza Dadkhah Tehrani
Street address
Farvardin
City
Ahwaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3001
Fax
+98 61 3374 3030
Email
dadkhahtehrani.m@ajums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Tirandaz
Street address
Farvardin
City
Ahwaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3001
Fax
+98 61 3374 3030
Email
Fatemetirandaz@gmial.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Reza Dadkhah Tehrani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Farvradin
City
Ahwaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3001
Fax
+98 61 3374 3030
Email
dadkhahtehrani.m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fateme Tirandaz
Position
Emergency medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Farvardin
City
Ahwaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3001
Fax
+98 61 3374 3030
Email
Fatemetirandaz@gmial.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad reza dadkhah Tehrani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Farvardin
City
Ahwaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3001
Fax
+98 61 3374 3030
Email
dadkhahtehrani.m@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available