Promethazine vs. Lorazepam for Treatment of Vertigo

This study has been completed.
Information provided by (Responsible Party):
Shadi Asadollahi, Shaheed Beheshti Medical University Identifier:
First received: April 2, 2013
Last updated: June 13, 2013
Last verified: June 2013
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.

Condition Intervention Phase
Peripheral Vertigo.
Drug: Promethazine
Drug: Lorazepam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promethazine vs. Lorazepam for Treatment of Vertigo in the Emergency Department: A Randomized Clinical Trial

Resource links provided by NLM:

Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • Mean change in vertigo intensity. [ Time Frame: At 2 hours after intervention. ] [ Designated as safety issue: No ]
    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:
  • Efficacy and Safety outcome measures (nausea change-second dose-adverse events). [ Time Frame: At 2-8 hours after intervention. ] [ Designated as safety issue: Yes ]
    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.

Enrollment: 210
Study Start Date: April 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Promethazine
IV promethazine (25 mg)
Drug: Promethazine Drug: Lorazepam
Active Comparator: lorazepam
IV lorazepam (2 mg)
Drug: Promethazine Drug: Lorazepam


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01827293

Iran, Islamic Republic of
Department of Neurology, Emam Hossein Hospital
Tehran, Nezam Abad, Iran, Islamic Republic of, 17666-33815
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
  More Information

Responsible Party: Shadi Asadollahi, Research Assistant, Shaheed Beheshti Medical University Identifier: NCT01827293     History of Changes
Other Study ID Numbers: SB-067 
Study First Received: April 2, 2013
Last Updated: June 13, 2013
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Ear Diseases
Labyrinth Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms
Vestibular Diseases
Anesthetics, Local
Anti-Allergic Agents
Anti-Anxiety Agents
Autonomic Agents
Central Nervous System Depressants
Dermatologic Agents
GABA Agents
GABA Modulators
Gastrointestinal Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Hypnotics and Sedatives processed this record on May 26, 2016