Background: Acute peripheral vertigo is a common complaint in emergency department and oligoanalgesia is a known phenomenon due to staff involvements and the chaotic environment of emergency department. Thus oral forms of drugs are the preferred forms in emergency departments.
This trial compares the efficacy and safety of oral betahistine and intravenous diazepam in adult patients presenting in an academic emergency department with 50'000 patients annually.
Participants: Inclusion criteria are patients over 18 years old with peripheral acute vertigo.
Exclusion criteria are contraindications of diazepam and betahistine;
advanced cardiac, pulmonary and cerebrovascular diseases.
Intervention: First group will receive Betahistine and intravenous(IV) placebo and second group will receive oral placebo an IV Diazepam.
Outcome: Symptom relief will be recorded in 0 and 6 hours after treatment and side effects will be recorded after 6 hours in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112208104N2
Registration date:2012-09-16, 1391/06/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-16, 1391/06/26
Registrant information
Name
Mohammad Amin Zare
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 5327
Email address
ma-zare@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-01-01, 1389/10/11
Expected recruitment end date
2011-06-02, 1390/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral betahistine with intravenous diazpam in acute peripheral vertigo
Public title
Comparison of oral betahistine with intravenous diazpam in acute peripheral vertigo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patiets over 18 yeras old with peripheral acute vertigo
Exclusion criteria:
contraindications of diazepam and betahistine;
advanced cardiac, pulmonary and cerebrovascular diseases.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences ethics committee
Street address
Deputy of research, Ghods street, Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
144574311
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
133
Health conditions studied
1
Description of health condition studied
Acute peripheral vertigo
ICD-10 code
VIII
ICD-10 code description
Diseases of the ear and mastoid process
Primary outcomes
1
Description
Symptom control
Timepoint
0,2,4 and 6 hours after treatment
Method of measurement
Vertigo severity chart
Secondary outcomes
1
Description
Occurance of drug side effects
Timepoint
during the first 6 hours
Method of measurement
Monitoring the patient
Intervention groups
1
Description
beta histine 8 mg as treatment and stilled water 5 ml as placebo was given to first group
Category
Treatment - Drugs
2
Description
Diazepam 5 mg intravenous and oral placebo was given to second group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Rasool Hospital
Full name of responsible person
Mohammad Amin Zare
Street address
Niyayesh street, sattarkhan, tehran, iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical sciences; Deputy of research
Full name of responsible person
Shahin Akhoundzade
Street address
Poursina st, Keshavarz blv, Faculty of medicine
City
Tehran
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran university of medical sciences; Deputy of research