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Completed

NCT Number: NCT01827293

Promethazine vs. Lorazepam for Treatment of Vertigo

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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Key information

Conditions

Peripheral Vertigo. Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Neurology, Emam Hossein Hospital

Tehran, Nezam Abad, 17666-33815, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Promethazine

Drug

Lorazepam

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 9, 2013
Registry last updated
Jun 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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