Comparison of the effect of intravenous promethazine and diazepam on the reduction of peripheral true vertigo symptom among the patient admitted to the emergency ward in Shahid Mohammadi hospital
This study is a double blind clinical trial designed to compare the effect of promethazine and diazepam regarding the ability of controlling the symptom of peripheral vertigo in emergency department. Due to uncertainty of their prescribed priority in emergency reference books, the design of this study seems essential central vertigo is the main exclusion criteria. study time is considered as a 6 month interval.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061210330N2
Registration date:2017-06-26, 1396/04/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-26, 1396/04/05
Registrant information
Name
Seyed Ashkan Tabibzadeh
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 1333 7192
Email address
dr.atabibzadeh@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intravenous promethazine and diazepam on the reduction of peripheral true vertigo symptom among the patient admitted to the emergency ward in Shahid Mohammadi hospital
Public title
Comparison of the effect of promethazine and diazepam on the treatment of peripheral vertigo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria of study :patients admitted to Shahid Mohammadi hospital with true vertigo; patients admitted to Shahid Mohammadi hospital over 18 years old and less than 70 years old;patients who do not intake anti-vertigo drugs before comming to hospital.
Exclusion criteria: pregnant women; individual who suffer from know drug's allergy; people who drink alcohol; patients who feel vertigo by using drugs; patients who suffer from advanced liver disease; patients who need to follow up with more checks.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
154
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
Hormozgan University of Medical Sciences
Street address
Bandar abbas -Jomhoori eslami Blvd-The east side of the hospital Shaid Mohammadi
City
Bandar abbas
Postal code
Approval date
2016-12-22, 1395/10/02
Ethics committee reference number
IR.HUMS.REC.1395.031
Health conditions studied
1
Description of health condition studied
Vertigo
ICD-10 code
R42
ICD-10 code description
Dizziness and giddiness
Primary outcomes
1
Description
Severity of vertigo
Timepoint
At the start of study and 30 minutes after prescription
Method of measurement
The visual and verbal questionnaire
Secondary outcomes
1
Description
vomiting
Timepoint
the start of study-30 minutes after Prescription
Method of measurement
the visual and verbal questionare
2
Description
ataxia
Timepoint
the start of study-30 minutes after Prescription
Method of measurement
the visual and verbal questionare
3
Description
nystagmus
Timepoint
the start of study-30 minutes after Prescription
Method of measurement
the visual and verbal questionare
Intervention groups
1
Description
Diazepam is an injection of 10 mg should be dissolved in 100 ml of normal saline solution a infusion within 20 -30 minutes.
Category
Treatment - Drugs
2
Description
Promethazine an injection of 25 mg should be dissolved in 100 ml of normal saline solution a infusion within 20 -30 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The emergency ward in Shahid Mohammadi hospital
Full name of responsible person
Seyed AshkanTabibzade
Street address
Shaid Mohammadi hospital, Jomhoori eslami Blvd.
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Seyed Ashkan Tabibzade
Street address
Ostandari Blvd -Hormozgan University of Medical Sciences
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan 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
Hormozgan University of Medical Sciences
Full name of responsible person
Seyed Ashkan Tabibzade
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Hormozgan University of Medical Sciences, Ostandari Blvd.
City
Bandar Abbas
Postal code
Phone
+98 763337192
Fax
Email
dr.tabib52@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Seyed Ashkan Tabibzade
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Hormozgan University of Medical Sciences, Ostandari Blvd.
City
Bandar Abbas
Postal code
Phone
+98 763337192
Fax
Email
dr.tabib52@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Seyed Ashkan Tabibzade
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Hormozgan University of Medical Sciences, Ostandari Blvd.
City
Bandar Abbas
Postal code
Phone
+98 763337192
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)