comparision of the effect of intervenous promethazine and diazepam on the reduction of peripheral true vertigo symptom s among the patients admited to the emergency ward
This study is a double blind clinical trial designed to compare the effect of promethazine and diazepam regarding the ability of controling 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
A)The study population:The main study criteria is peripheral vertigo and central vertigo is the main exclusion criteria.Sample size: 154 individual
B) Intervention study:
Intervention groups are divided into two categories ,A and B that
The other intravenous promethazine, one of which they received intravenous diazepam
C)the time of intervention: 5 months
ِD)The outcome of study:Primary outcome,severity of vertigo ؛ Secondary outcome, vomiting ,ataxia , nystagmus
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100530095N2
Registration date:2016-11-18, 1395/08/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-11-18, 1395/08/28
Registrant information
Name
Seyed ashkan Tabibzadeh
Name of organization / entity
Hormozgan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 761333470015
Email address
dr.tabib52@gmail.com
Recruitment status
Recruitment complete
Funding source
Hormozgan university of medical sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-05-20, 1396/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparision of the effect of intervenous promethazine and diazepam on the reduction of peripheral true vertigo symptom s among the patients admited to the emergency ward
Public title
The comparison between Promethazine and diazepam in the treatment of peripheral vertigo.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria of study: patients admitted to Shahidmohammadi hospital with true vertigo؛ patients admitted to Shahidmohammadi 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 ؛ individuals who suffer from know drug"s allergy ؛ people who drink alcohol ؛ people who feel vertigo by using drugs ؛ people who seffer from advanced liver diseases ؛ patients who need to follow up with father checks ؛ people who do not cooperate in filling the questionaire
Age
From 18 years old to 70 years old
Gender
Both
Phase
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
Deputy of research and technology-Hormozgan university medical sciences
Street address
BandarAbbas- Jomhuri Blvd-East side of ShahidMohamadi hospital
City
BandarAbbas
Postal code
79199-15519
Approval date
2016-05-18, 1395/02/29
Ethics committee reference number
89-94/20
2
Ethics committee
Name of ethics committee
Hormozgan university of medical sciences
Street address
BandarAbbas-Jomhouri Blvd-East side of ShahidMohamadi hospital
City
BandarAbbbas
Postal code
79199-15519
Approval date
2016-05-18, 1395/02/29
Ethics committee reference number
HUMS.REC.1395.031
Health conditions studied
1
Description of health condition studied
The reduction of severity of peripheral true vertigo
ICD-10 code
H81.3
ICD-10 code description
Other peripheral vertigo
Primary outcomes
1
Description
severity of vertigo
Timepoint
The beging of study 30 minutes after drug's prescription
Method of measurement
The visual and verbal questionair
Secondary outcomes
1
Description
vomiting ,ataxia , nystagmus
Timepoint
The begining of study 30 minutes after intaking medicine
Method of measurement
The visual and verbal questionair
Intervention groups
1
Description
A) Type of intervention in the intervention group: The use of an injection of is promethazine (25mg) is dissolved in 100ml of normal-saline solution and infusion with in 20-30 minutes
Category
Treatment - Drugs
2
Description
B)Type of intervention in the control group:The use of an injection of diazepam (10mg) is dissolved in 100ml of normal-saline solution and infusion with in 20-30 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ShahidMohammadi hospital
Full name of responsible person
Dr. Seyed Ashkan Tabibzadeh
Street address
The emergency department of ShahidMohamadi hosptal
City
BandarAbbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan university medical sciences
Full name of responsible person
Dr.seyed Ashkan Tabibzadeh
Street address
The emergency department of ShahidMohammadi hospital
City
BandarAbbas
Grant name
بوجه طرح های آزمایشی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan university 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 medical sciences
Full name of responsible person
Dr.Seyed Ashkan Tabibzadeh
Position
Emergency medicine specialist /Director of emergency medicine
Other areas of specialty/work
Street address
The emergency department of ShahidMohamadi
City
BandarAbbas
Postal code
79199-15519
Phone
+98 76 3333 4700
Fax
Email
ashkantz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan university medical sciences
Full name of responsible person
Dr.Seyed Ashkan Tabibzadeh
Position
Emergency medicine specialist/full- time faculty member
Other areas of specialty/work
Street address
The emergency department of ShahidMohamadi hospital
City
BandarAbbas
Postal code
79199-15519
Phone
+98 76 3333 4700
Fax
Email
ashkantz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hormozgan university medical sciences
Full name of responsible person
Dr.Seyed Ashkan Tabibzadeh
Position
Emergency medicine specialist/full- time faculty member
Other areas of specialty/work
Street address
The emergency department of ShahidMohamadi hospital
City
BandarAbbas
Postal code
79199-15519
Phone
+98 76 3333 4700
Fax
Email
ashkantz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)