Comparison of the efficacy of intravenous sodium valproate and acetaminophen(paracetamol) in attacks of headaches
Design
Patients with acute headache attack were admitted to emergency department and neurology department of Amiral-Momenin Hospital enter this study. Study is a double-blind and clinical trial. The sample size is 70 people.
Settings and conduct
Patients with acute headache attack were admitted to emergency department and neurology department of Amiral-Momenin Hospital enter this study. Study is a double-blind and clinical trial. Simple individual randomization with random number table in division of groups in two groups A and B.This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor
Participants/Inclusion and exclusion criteria
Inclusion criteria: Normal systemic and neurological examinations, 20 to 50 yeras
Exclusion criteria: Allergy to acetaminophen, Hyperammonium ,lack of cooperation
Intervention groups
In the first group, we inject valproate 400 milligram intravenously and infused slowly, and second group we inject ampule of acetaminophen (paracetamol, apothel) of 500 milligram.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N102
Registration date:2019-04-07, 1398/01/18
Registration timing:registered_while_recruiting
Last update:2019-04-07, 1398/01/18
Update count:0
Registration date
2019-04-07, 1398/01/18
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of intravenous sodium valproate and acetaminophen(paracetamol) in attacks of headaches
Public title
Comparison of the efficacy of intravenous sodium valproate and acetaminophen in attacks of headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Normal systemic and neurological examinations
20 to 50 yeras
Exclusion criteria:
Allergy to acetaminophen
Hyperammonium
Lack of cooperation
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random number table in division of groups in two groups A and B.
Randomization method: Simple randomization.
Random unit: Individual.
How to build sequences: First, we set the framework for our statistical society. We started from a table point in a row or column. Given the type of code in the row, we chose the same number of digits. After that, the numbers control the path. We noticed smaller numbers of the statistical community. We have to continue this work so that the number of samples is completed.Even numbers were used for intervention group and odd numbers were used for the control group.
Allocation concealment:Numbered drug containers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2018-12-30, 1397/10/09
Ethics committee reference number
IR.ARAKMU.REC.1397.260
Health conditions studied
1
Description of health condition studied
Migraine headach
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
pain
Timepoint
One and six hours after the start of the study
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first group, we inject valproate 400 milligram intravenously and infused slowly
Category
Treatment - Drugs
2
Description
Intervention group: In second group we inject ampule of acetaminophen (paracetamol, apothel) of 500 milligram.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Fardin Faraji
Street address
Sardasht, Basij squre,Amiralmomenin hospital
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
faraji@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandadegan
Street address
Vice Chancellor For Research, Arak University Of Medical Science
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Behzadi nia
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street