Promethazine vs. Lorazepam for Treatment of Vertigo
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ClinicalTrials.gov Identifier: NCT01827293
: April 9, 2013
Last Update Posted
: June 14, 2013
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
Shadi Asadollahi, Shaheed Beheshti Medical University
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.
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.
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Aged 18 years or older
Background history of positional vertigo
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