Peripheral Vertigo.
Conditions
Brief summary
This study was a prospective, randomized, double-blind, parallel group clinical trial designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the treatment of peripheral vertigo in Emergency Department setting.
Interventions
DRUGPromethazine
DRUGLorazepam
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Background history of positional vertigo
Exclusion criteria
* Unable to provide informed consent * Pregnant or possibly pregnant * Known allergy to study medications * Use of antiemetic agents in the previous 24 hours * Evidence of drug-induced vertigo or orthostatic hypotension * Central pathologies/central origin for vertigo
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in vertigo intensity. | At 2 hours after intervention. | The primary efficacy outcome was the mean change in the vertigo intensity score between pre- and post-intervention at 2 hours after administration of study medications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy and Safety outcome measures (nausea change-second dose-adverse events). | At 2-8 hours after intervention. | Secondary outcomes included, mean change in nausea VAS score, need for second dose of study medications, and the rate of drug-related adverse events for the subjects in each study group after intervention. |
Countries
Iran
Outcome results
None listed