1. Comparing the effectiveness of intravenous promethazine and diazepam in treating peripheral vertigo in patients who have referred to Emergency Unit of Baqiatullah (may Allah hasten his honorable appearance) Hospital during the time span from 2015 to 2016
Promethazine and diazepam effectiveness in treating peripheral vertigo in patients who have referred to emergency unit of Baqiatullah (may Allah hasten his honorable appearance) Hospital has been evaluated
Design
The present study is a randomized clinical trial conducted on peripheral vertigo patients who have referred to Baqiatullah (may Allah hasten his honorable appearance) Hospital during the time span from 2015 to 2016
Settings and conduct
The patients completed the demographic information form and VAS (visual analog scale) questionnaire in such a manner that the patients were asked to score their intensity of vertigo with a number ranging from 1 to 10. Next, the patients were randomly assigned to two groups (based on random numbers table). Afterwards, the group one received intravenous promethazine for a dosage of 25 mg/ml and the second group was administered 5 mg/ml intravenous diazepam. The patients were asked to complete VAS form for a second time two hours after being administered with the drug. In case of developing drug-induced symptoms, they were recorded in the questionnaire form. Higher dosages of the same drugs were administered in case that the desired response to the drug was not acquired. Finally, the information obtained from the patients was analyzed by the study executor. The study was implemented in emergency unit of Baqiatullah (may Allah hasten his honorable appearance) Hospital
Participants/Inclusion and exclusion criteria
The eighteen-year-old individuals with peripheral vertigo who have referred to the emergency unit. The patients with the following conditions were discarded from the study: expression of dissatisfaction to continue with the study, pregnant women, a history of allergy to the drugs administered in the study, taking antivertigo drugs during the past 24 hours, the development of signs of drug-induced dizziness, central vertigo symptoms and a history of traumatic brain injury. The aforementioned cases will be determined through self-report and examination
Intervention groups
17. Individuals with peripheral vertigo
Main outcome variables
The eighteen-year-old individuals with peripheral vertigo who have referred to the emergency unit
General information
Reason for update
Acronym
ipd
IRCT registration information
IRCT registration number:IRCT20171221037984N1
Registration date:2018-02-06, 1396/11/17
Registration timing:retrospective
Last update:2018-02-06, 1396/11/17
Update count:0
Registration date
2018-02-06, 1396/11/17
Registrant information
Name
ZOHREH NABIZADEH GHARGOZAR
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2269 2556
Email address
nabizadeh-z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
2015-03-21, 1394/01/01
Actual recruitment end date
2016-05-19, 1395/02/30
Trial completion date
empty
Scientific title
1. Comparing the effectiveness of intravenous promethazine and diazepam in treating peripheral vertigo in patients who have referred to Emergency Unit of Baqiatullah (may Allah hasten his honorable appearance) Hospital during the time span from 2015 to 2016
Public title
1. Comparing the effectiveness of intravenous promethazine and diazepam
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
7. The individuals, above 18 years of age, with motion sickness (peripheral vertigo) who have referred to emergency unit. The exclusion criteria are: expressing dissatisfaction to participate in the study, pregnant women, history of allergy to the drugs administered in the study, a history of taking antivertigo drugs during the past 24 hours, development of drug-induced motion sickness symptoms, existence of central vertigo and a history of traumatic brain injury. The abovementioned cases can be diagnosed in examinations and the patients’ self-report
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
164
Actual sample size reached:
164
Randomization (investigator's opinion)
Randomized
Randomization description
9. In such a way that the patients are asked to score their intensity of vertigo in a range from one to ten. Next, the patients will be randomly assigned to two groups (by the use of random numbers table). Then, one group will be treated by the use of intravenous promethazine (25 mg/ml) and the other will be subjected to IV diazepam (5mg/ml) treatment
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Ethics Committee Office of Shahid Beheshti University of Medical Sciences
Street address
Building Block One: No.5, ground floor, Medical Department, Shahid Beheshti Medical sciences University, Velenjak St., beside Taleqani Hospital, Tehran, Iran
City
tehran
Province
Tehran
Postal code
8156598765
Approval date
2016-03-30, 1395/01/11
Ethics committee reference number
IR-SBMU.MSP.REC.1395.385
2
Ethics committee
Name of ethics committee
Research and Ethics Committee Office of Shahid Beheshti University of Medical Sciences
Street address
31. Vanak Square, Baqiatullah (may Allah hasten his honorable appearance) Hospital
City
تهران
Province
Tehran
Postal code
8156598766
Approval date
2017-03-29, 1396/01/09
Ethics committee reference number
IR-SBMU.MSP.REC.1395.385
Health conditions studied
1
Description of health condition studied
Patients with peripheral vertigo
ICD-10 code
H81.3
ICD-10 code description
Other peripheral vertigo
Primary outcomes
1
Description
Vertigo Treatment
Timepoint
365 DAYS
Method of measurement
The Effectiveness OF Promethazine And Diazepam In tThe Treatment Of Peripheral Vertigo
Secondary outcomes
1
Description
The individuals who had referred to the emergency unit were asked to complete the demographic characteristic and visual analog scale (VAS) forms; in such a way that the patients were asked to give a number from 1 to 12 to the intensity of vertigo they experience. In the next stage, the patients were randomly assigned to two groups (based on random numbers table). Afterwards, the first group was given IV promethazine (25 mg/ml) and the second group received IV diazepam (5mg/ml). The patients were asked to fill in the VAS form two hours after being administered with the drugs. The drug-induced symptoms, if any, were recorded in the questionnaire form. In case that the patients do not respond to the treatment favorably, a second dosage of the same drug will be prescribed.
Timepoint
25 and 5
Method of measurement
the first group was given IV promethazine (25 mg/ml) and the second group received IV diazepam (5mg/ml). The patients were asked to fill in the VAS form two hours after being administered with the drugs. The drug-induced symptoms, if any, were recorded in the questionnaire form. In case that the patients do not respond to the treatment favorably, a second dosage of the same drug will be prescribed
Intervention groups
1
Description
Intervention group: the peripheral vertigo individuals who had referred to the emergency unit were subjected to treatment by IV promethazine for a dosage of 25mg/ml.
Category
Other
2
Description
Control group: the peripheral vertigo individuals who had referred to the emergency unit were subjected to treatment by IV diazepam for a dosage of 5mg/ml.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The study was carried out in the emergency unit of Baqiatullah (may Allah hasten his honorable appea
Full name of responsible person
23. Dr. Kamran Haidari
Street address
Vanak Square, Baqiatullah (may Allah hasten his honorable appearance) Hospital
City
tehran
Province
Tehran
Postal code
7158896858
Phone
+98 21 2661 8710
Email
nabizadehfaezeh85@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Kamran Haidari
Street address
24. Vanak Square, Baqiatullah (may Allah hasten his honorable appearance) Hospital
City
tehran
Province
Tehran
Postal code
8156598765
Phone
+98 21 2661 8710
Email
Heidari-k@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Kamran Haidari
Position
Emergency Medicine Associate Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tajrish Square, Shohaday-e-Tajrish Hospital
City
tehran
Province
Tehran
Postal code
7158896858
Phone
+98 21 2661 8710
Email
Heidari-k@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Javadzadeh
Position
Emergency Medicine Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Nursery
Street address
Vanak Square, Baqiatullah (may Allah hasten his honorable appearance) Hospital
City
tehran
Province
Tehran
Postal code
7158896859
Phone
+98 21 2661 8711
Email
nabizadehfaezeh85@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sayyed Mohsen Fayyazi
Position
Emergency Medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Nursery
Street address
Tajrish Square, Shohaday-e-Tajrish Hospital
City
tehran
Province
Tehran
Postal code
7158896862
Phone
+98 21 2661 8721
Email
mfayyazib@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Research and Ethics Committee Office of Shahid Beheshti University of Medical Sciences
When the data will become available and for how long
100 DAY
To whom data/document is available
Dr. Kamran Haidari
Under which criteria data/document could be used
Dr. Kamran Haidari
From where data/document is obtainable
33. Sayyed Mohsen Fayyazi
What processes are involved for a request to access data/document