Vertigo is among the most common reasons for emergency department visits, in which benign positional vertigo is a common etiology. Unlike repositioning maneuvers for the management of vertigo, evidence regarding drug therapy is very limited. This study aim to compare the effects of diazepam and promethazine in relieving ataxia in patients with acute peripheral vertigo. In a single blind clinical trial phase 3, seventy patients with acute peripheral vertigo and ataxia will be enrolled to the study. Patients were excluded from the study if any of the following criteria was present: syncope or cardiac event, central origin for vertigo, drug-induced vertigo or orthostatic hypotension, adverse reaction to diazepam and promethazine. Patients will divided into two intervention groups using simple randomization, first arm, include 35 patients who receive 5 mg of intravenous diazepam and the second arm has also 35 patients who receive 12.5 mg of intramuscular promethazine. The patients will reassessed 60 and 120 minutes after receiving the medication. The focus was on the effects of the medication on their ataxia, which was examined using both Romberg test and Tandem gait. Systolic and diastolic blood pressure as well as heart rate were measured and recorded. The patients were also questioned regarding any of the common medication side effects. The researchers will be masked about the study. The results of both groups will be compared with each other and statistically analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120722777N2
Registration date:2015-12-26, 1394/10/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-26, 1394/10/05
Registrant information
Name
Abdolghader Pakniyat
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 344 9177
Email address
a.pakniyat@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2014-08-28, 1393/06/06
Expected recruitment end date
2015-06-14, 1394/03/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of diazepam and promethazine in relieving ataxia in patients with acute peripheral vertigo, a clinical trial
Public title
treatment of ataxia in patients with acute peripheral vertigo.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged between 18-60 years old; acute peripheral vertigo and ataxia.
exclusion criteria: history of syncope or cardiac event; considerations of a central origin for vertigo; focal neurological deficits; known pregnancy; evidence of drug-induced vertigo or orthostatic hypotension; known dystonic or adverse reaction to diazepam and promethazine or other similar agents; report of taking medication within 24 hours of ED presentation that might affect the results (e.g., antihistamines, antipsychotics, opioid analgesics or sedatives).
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Simple randomization was performed by using a random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of َArak University of Medical Sciences
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Postal code
Approval date
2014-09-17, 1393/06/26
Ethics committee reference number
93-167-1
Health conditions studied
1
Description of health condition studied
Acute peripheral vertigo
ICD-10 code
H81.1
ICD-10 code description
Benign paroxysmal vertigo
Primary outcomes
1
Description
Ataxia
Timepoint
60 and 120 minutes after intervention
Method of measurement
Romberg Test and tandem gait test
Secondary outcomes
1
Description
blood pressure
Timepoint
60 and 120 minutes after intervention
Method of measurement
Sphygmomanometer
2
Description
Heart Rate
Timepoint
60 and 120 minutes after intervention
Method of measurement
Pulse oximetry
Intervention groups
1
Description
Intervention 1:
Patients with acute peripheral vertigo enroll to the study considering inclusion and exclusion criteria. First arm, include 35 patients who receive 5 mg of intravenous diazepam. The patients will reassessed 60 and 120 minutes after receiving the medication. The focus was on the effects of the medication on their ataxia, which was examined using both Romberg test and Tandem gait. Systolic and diastolic blood pressure as well as heart rate were measured and recorded. The patients were also questioned regarding any of the common medication side effects. The results of both groups will be compared with each other and statistically analyzed.
Category
Treatment - Drugs
2
Description
Intervention 2:
Patients with acute peripheral vertigo enroll to the study considering inclusion and exclusion criteria. First arm, include 35 patients who receive 12.5 mg of intramuscular promethazine. The patients will reassessed 60 and 120 minutes after receiving the medication. The focus was on the effects of the medication on their ataxia, which was examined using both Romberg test and Tandem gait. Systolic and diastolic blood pressure as well as heart rate were measured and recorded. The patients were also questioned regarding any of the common medication side effects. The results of both groups will be compared with each other and statistically analyzed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-Asr Hospital
Full name of responsible person
Maryam Vakili
Street address
Vali-Asr Sq.
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiei
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Arak University of Medical Sciences