This study is designed to compare the efficacy of intravenous Promethazine versus intravenous Diazepam for the treatment of Peripheral Vertigo in the Emergency Department . This study is a double blind randomized clinical trial conducted on 150 patients. Inclusion criteria: male and female patients aged 18 to 65 years with complaints of vertigo , Exclusion criteria: patients with central vertigo; Head Trauma; Pregnancy. Patients with a diagnosis of Acute Peripheral Vertigo were randomly divided into two groups A and B. to Group A intravenous Diazepam 5 mg and to group B 25 mg Promethazine intravenously injected. The intensity of vertigo in patients is determined by VAS tool. Efficacy in 30 minutes, 2 and 4 hours after drug administration are examined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060122522N1
Registration date:2015-07-04, 1394/04/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-04, 1394/04/13
Registrant information
Name
Leila Shafipour
Name of organization / entity
Mazandaran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 9044
Email address
lshafipour@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University Of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intravenous Promethazine Versus Diazepam for Treatment of Peripheral Vertigo in the Emergency Department
Public title
Intravenous Promethazine Versus Diazepam for Treatment of Peripheral Vertigo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Aged 18 - 65 years; Complaining of Vertigo ; There is not contraindication for intravenous promethazine and diazepam
Exclusion criteria: Patient with centeral vertigo; Traumatic Brain Injury; Pregnant; Unable to provide informed consent
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
N/A
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
City
Sari
Postal code
Approval date
2015-06-01, 1394/03/11
Ethics committee reference number
IR.MAZUMS.REC.94.1175
Health conditions studied
1
Description of health condition studied
Vertigo
ICD-10 code
VIII
ICD-10 code description
Diseases of the ear and mastoid process
Primary outcomes
1
Description
Control Of Symptoms
Timepoint
30 minutes, 2 and 4 hours
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
In group A , 5 mg of diazepam intravenously injected.
Category
Treatment - Drugs
2
Description
In group B , 25 mg of promethazine intravenously injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hospital
Full name of responsible person
Dr Golikhatir
Street address
Imam Hospital Emergency Department
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Dr Golikhatir
Street address
Imam Hospital
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr golikhatir
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Hospital Emergency Department
City
Sari
Postal code
-
Phone
+98 11 3336 4044
Fax
-
Email
Drgolikhatir@gmail.com ; lshafipour@mazums.ac.ir
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Iraj Golikhatir
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Hospital Emergency Department
City
Sari
Postal code
-
Phone
+98 11 3336 4044
Fax
-
Email
lshafipour@mazums.ac.ir ; Drgolikhatir@gmail.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Dr Leila Shafipour
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
Imam Hospital
City
Sari
Postal code
4816633131
Phone
+98 11 3311 9044
Fax
Email
lshafipour@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)