Promethazine vs. Lorazepam for Treatment of Vertigo

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.

Full Title of Study: “Promethazine vs. Lorazepam for Treatment of Vertigo in the Emergency Department: A Randomized Clinical Trial”

Study Type

  • 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

Interventions

  • 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

Primary 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.

Secondary Measures

  • 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

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • 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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