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.
Full Title of Study: “Promethazine vs. Lorazepam for Treatment of Vertigo in the Emergency Department: A Randomized Clinical Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: June 2013
- Drug: Promethazine
- Drug: Lorazepam
Arms, Groups and Cohorts
- Active Comparator: Promethazine
- IV promethazine (25 mg)
- Active Comparator: lorazepam
- IV lorazepam (2 mg)
Clinical Trial Outcome Measures
- Mean change in vertigo intensity.
- Time Frame: 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.
- Efficacy and Safety outcome measures (nausea change-second dose-adverse events).
- Time Frame: 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.
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Provider of Information About this Clinical Study
- Principal Investigator: Shadi Asadollahi, Research Assistant – Shahid Beheshti University of Medical Sciences
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