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 intamussle promethazine in adult patients presenting in an academic emergency department. Participants: Inclusion criteria are patients18-65 years old with peripheral acute vertigo. Exclusion criteria are contraindications of promethazin and betahistine; pregnant and breast feeding women, central vertigo. Intervention: First group will receive Betahistine and intra muscle (IM) placebo and second group will receive oral placebo an IM promethazin. Outcome: Symptom relief will be recorded in 0 and 4 hours after treatment and side effects will be recorded after 4 hours in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062022834N1
Registration date:2015-07-11, 1394/04/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-07-11, 1394/04/20
Registrant information
Name
Zahra Izadi
Name of organization / entity
Jundishapur University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3554 9213
Email address
izadi.zahra@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundishapur University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral Betahistine and intramuscular promethazine in treatment of acute peripheral vertigo in emergency department
Public title
Comparison of oral Betahistine and intramuscular promethazine in treatment of acute peripheral vertigo in emergency department
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 18-65 years old with peripheral acute vertigo. Exclusion criteria: contraindications of promethazin and betahistine; pregnant and breast feeding women; central vertigo.
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:
160
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
Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical sciences, Farvardin st., Golestan
City
Ahvaz
Postal code
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
ir.ajums.rec.1394.93
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, 1, 2 and 4 hours after treatment
Method of measurement
VAG score
Secondary outcomes
1
Description
Occurance of drug side effects
Timepoint
During the first 4 hours
Method of measurement
Monitoring the patient
Intervention groups
1
Description
Betahistine 8 mg as treatment and stilled water 2 ml as placebo was given to first group
Category
Treatment - Drugs
2
Description
Promethazine 25 mg intramuscle and oral placebo was given to second group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Jundishapur University of Medical sciences, Farvardin st., Golestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundishapur 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
Jundishapur University of Medical Sciences
Full name of responsible person
Meisam Moezi
Position
Assistant Professor
Other areas of specialty/work
Street address
Jundishapur University of Medical sciences, Farvardin st., Golestan
City
Ahvaz
Postal code
Phone
+98 61 3374 3001
Fax
Email
Meisam-88@yahoo.com; moezi_m@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Meisam Moezi
Position
Assistant Professor
Other areas of specialty/work
Street address
Jundishapur University of Medical sciences, Farvardin st., Golestan
City
Ahvaz
Postal code
Phone
+98 61 3374 3001
Fax
Email
Meisam-88@yahoo.com; meisam_m@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Meisam Moezi
Position
Assistant Professor
Other areas of specialty/work
Street address
Jundishapur University of Medical sciences, Farvardin st., Golestan
City
Ahvaz
Postal code
Phone
+98 61 3374 3001
Fax
Email
Meisam-88@yahoo.com; moezi_m@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)