Promethazine vs. Lorazepam for Treatment of Vertigo

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01827293
• Collaborator: (none)
• Enrollment: 210
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 104.8

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Peripheral Vertigo.	Drug: Promethazine; Drug: Lorazepam	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 210 participants
• 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
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mean change in vertigo intensity. [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

1. Efficacy and Safety outcome measures (nausea change-second dose-adverse events). [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurology, Emam Hossein Hospital	Tehran	Nezam Abad	Iran, Islamic Republic of	17666-33815

Sponsors and Collaborators

• Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shadi Asadollahi, Research Assistant, Shahid Beheshti University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT01827293
• Other Study ID Numbers: SB-067
• First Posted: Apr 9, 2013
• Last Update Posted: Jun 14, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Vertigo; Dizziness; Promethazine; Diphenhydramine; Lorazepam

Study Results

No Results Posted as of Jun 14, 2013