Promethazine vs. Lorazepam for Treatment of Vertigo

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Peripheral Vertigo.

Treatments: Drug: Promethazine; Drug: Lorazepam

Study type: Interventional

Funder types: Other

Identifiers

NCT01827293

SB-067

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 2 patient groups

Promethazine

Active Comparator group

Description:

IV promethazine (25 mg)

Treatment:

Drug: Promethazine

Drug: Lorazepam

lorazepam

Active Comparator group

Description:

IV lorazepam (2 mg)

Treatment:

Drug: Promethazine

Drug: Lorazepam