Promethazine vs. Lorazepam for Treatment of Vertigo

Shahid Beheshti University of Medical Sciences210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

210

Conditions

Peripheral Vertigo.

Interventions

PromethazineDRUG

LorazepamDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Neurology, Emam Hossein Hospital

Tehran, Nezam Abad, Iran

Outcomes

Primary Outcomes

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.

Time frame: At 2 hours after intervention.

Secondary Outcomes

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.

Time frame: At 2-8 hours after intervention.

Data from ClinicalTrials.gov

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