Promethazine vs. Lorazepam for Treatment of Vertigo

Promethazine vs. Lorazepam for Treatment of Vertigo in the Emergency Department: A Randomized Clinical Trial

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 Overview

• Status: Completed
• Conditions: Peripheral Vertigo.
• Intervention / Treatment: Drug: Lorazepam; Drug: Promethazine

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Nezam Abad
    • Tehran, Nezam Abad, Iran, Islamic Republic of, 17666-33815
      • Department of Neurology, Emam Hossein Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Promethazine; IV promethazine (25 mg)	Drug: Lorazepam; Drug: Promethazine
Active Comparator: lorazepam; IV lorazepam (2 mg)	Drug: Lorazepam; Drug: Promethazine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 2, 2013
• First Submitted That Met QC Criteria: April 4, 2013
• First Posted (Estimate): April 9, 2013

Study Record Updates

• Last Update Posted (Estimate): June 14, 2013
• Last Update Submitted That Met QC Criteria: June 13, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Dizziness; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Anesthetics, Local; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Diphenhydramine; Promethazine; Lorazepam
• Other Study ID Numbers: SB-067