Promethazine vs. Lorazepam for Treatment of Vertigo

NCT01827293 — Phase 3, Completed, 210 participants, Shahid Beheshti University of Medical Sciences

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Promethazine vs. Lorazepam for Treatment of Vertigo in the Emergency Department: A Randomized Clinical Trial

Registry	NCT01827293
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	210 (Actual)
Sponsor	Shahid Beheshti University of Medical Sciences (Other)
Conditions	Peripheral Vertigo.
Interventions	Promethazine, Lorazepam (Drug)
Dates	start 2013-04-01, primary completion 2013-06-01, completion 2013-06-01, first posted 2013-04-09, last updated 2013-06-14
Locations	1 site in Iran

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Promethazine	Active comparator	Drug: Promethazine; Drug: Lorazepam	IV promethazine (25 mg)
lorazepam	Active comparator	Drug: Promethazine; Drug: Lorazepam	IV lorazepam (2 mg)

Promethazine (Drug)
Lorazepam (Drug)

+Outcome measures

Primary outcomes

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 outcomes

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

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Department of Neurology, Emam Hossein Hospital	Tehran, Nezam Abad	Iran