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

Kocaeli University

Status and phase: Completed; Phase 4

Conditions: Peripheral Vertigo

Treatments: Drug: 2 g piracetam intravenous; Drug: Administration of 100 mg dimenhydrinate intravenous

Study type: Interventional

Funder types: Other

Identifiers

NCT01890538

KOU KAEK 2013/174

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups

Piracetam

Active Comparator group

Description:

2 g intravenous piracetam

Treatment:

Drug: 2 g piracetam intravenous

Dimenhydrinate

Active Comparator group

Description:

Dimenhydrinate 100 mg intravenous

Treatment:

Drug: Administration of 100 mg dimenhydrinate intravenous