Promethazine vs. Lorazepam for Treatment of Vertigo
- Registration Number
- NCT01827293
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lorazepam Promethazine IV lorazepam (2 mg) lorazepam Lorazepam IV lorazepam (2 mg) Promethazine Promethazine IV promethazine (25 mg) Promethazine Lorazepam IV promethazine (25 mg)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Department of Neurology, Emam Hossein Hospital
🇮🇷Tehran, Nezam Abad, Iran, Islamic Republic of