Promethazine vs. Lorazepam for Treatment of Vertigo

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shadi Asadollahi, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01827293
First received: April 2, 2013
Last updated: June 13, 2013
Last verified: June 2013
  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
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 Medical University:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Medical University
  More Information

No publications provided

Responsible Party: Shadi Asadollahi, Research Assistant, Shaheed Beheshti Medical University
ClinicalTrials.gov 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:
Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders
Promethazine
Diphenhydramine
Lorazepam
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 31, 2014