Peripheral Vertigo. Clinical Trial
Official title:
Promethazine vs. Lorazepam for Treatment of Vertigo in the Emergency Department: A Randomized Clinical Trial
| Verified date | June 2013 |
| Source | hahid Beheshti University of Medical Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Iran: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 210 |
| Est. completion date | June 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Iran, Islamic Republic of | Department of Neurology, Emam Hossein Hospital | Tehran | Nezam Abad |
| Lead Sponsor | Collaborator |
|---|---|
| hahid Beheshti University of Medical Sciences |
Iran, Islamic Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean change in vertigo intensity. | 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. | At 2 hours after intervention. | No |
| Secondary | Efficacy and Safety outcome measures (nausea change-second dose-adverse events). | 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. | At 2-8 hours after intervention. | Yes |