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Promethazine vs. Lorazepam for Treatment of Vertigo

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01827293
First Posted: April 9, 2013
Last Update Posted: June 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shadi Asadollahi, Shaheed Beheshti Medical University
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Shadi Asadollahi, Shaheed Beheshti Medical University:

Primary 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.


Secondary Outcome 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.


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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827293


Locations
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
ClinicalTrials.gov Identifier: NCT01827293     History of Changes
Other Study ID Numbers: SB-067
First Submitted: April 2, 2013
First Posted: April 9, 2013
Last Update Posted: June 14, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders
Lorazepam
Diphenhydramine
Promethazine
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents


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