Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo

Phase 4

Completed

• Conditions: Peripheral Vertigo
• Interventions: Drug: 2 g piracetam intravenous; Drug: Administration of 100 mg dimenhydrinate intravenous

• Registration Number: NCT01890538
• Lead Sponsor: Kocaeli University

Brief Summary

This study aims to investigate efficacy of two different intravenous drugs (dimenhydrinate and piracetam) in the symptomatic management of peripheral vertigo.

The patients will be randomized in two groups according to symptomatic treatment modalities: Dimenhydrinate (100 mg) and piracetam (2 g) will be given in 100 cc normal saline in 30 minutes. Each patient will be asked if her/his vertigo symptoms resolved or not, according to a numeric rating scale (0=no vertigo, 10=worst possible vertigo). The patient will be rate the intensity of symptoms in the following times:

* Numeric rating scale (1 to 10): Admission

* Numeric rating scale (1 to 10): After the study drug (No ambulation)\*

* Numeric rating scale (1 to 10): After the study drug (Ambulation)\*

* Ambulation refers to head movements or walking in the room, if applicable.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-07-01
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-02
• Last Update Posted: 2014-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Presenting to emergency department with vertigo symptoms
• Adult patients (over 18)
• Agree to participate to study (understanding the study protocol and signing the informed consent form)

Exclusion Criteria

• Patients under 18 years
• Patients diagnosed with ischemic/hemorrhagic stroke after neuroimaging
• Patient diagnosed with transient ischemic attack
• Pregnants
• Patients taking any analgesics or antihistaminic drugs last 24 hours
• Documented or declared allergy to dimenhydrinate, piracetam or benzodiazepines
• Patients who do not agree to participate to the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Piracetam	2 g piracetam intravenous	2 g intravenous piracetam
Dimenhydrinate	Administration of 100 mg dimenhydrinate intravenous	Dimenhydrinate 100 mg intravenous

Primary Outcome Measures

Name	Time	Method
Change in numeric rating scale	Change from baseline in numeric rating scale at 30th minute

Trial Locations

Locations (1)

Kocaeli University; 🇹🇷 Kocaeli, Turkey