Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Promethazine

+ Lorazepam

+ Promethazine

Drug
Who is being recruted

Ear Diseases+6

+ Labyrinth Diseases

+ Nervous System Diseases

From 18 to 65 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorShahid Beheshti University of Medical Sciences
Last updated: June 14, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01827293
Principal SponsorShahid Beheshti University of Medical Sciences
Last updated: June 14, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

210 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ear DiseasesLabyrinth DiseasesNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVestibular DiseasesVertigo

Criteria

2 inclusion criteria required to participate
Aged 18 years or older
Background history of positional vertigo
6 exclusion criteria prevent from participating
Central pathologies/central origin for vertigo
Evidence of drug-induced vertigo or orthostatic hypotension
Known allergy to study medications
Pregnant or possibly pregnant
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
IV promethazine (25 mg)

Group II

Active Comparator
IV lorazepam (2 mg)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Neurology, Emam Hossein Hospital

Tehran, IranOpen Department of Neurology, Emam Hossein Hospital in Google Maps
CompletedOne Study Center