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Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo
Sponsor: University of Monastir
Summary
This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED
Official title: Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo: A Randomized Controlled Double Blinded Study
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2024-05-01
Completion Date
2026-03-30
Last Updated
2024-04-02
Healthy Volunteers
No
Conditions
Interventions
Diazepam 5mg
For the intervention, patients will be randomly allocated into three groups. Each patient will be randomized to one of three treatment groups: diazepam 5 mg (5 mg/1 mL), . Medications will be diluted with 5 mL of normal saline solution slowly intravenously injected (over 5 minutes). The associate clinical research coordinator was responsible for preparation and dispensing the study drug. The investigators, treating physicians, nurses, and patients were blinded to the treatment.
Diazepam 10 mg
For the intervention, patients will be randomly allocated into three groups. Each patient will be randomized to one of three treatment groups: diazepam10 mg (5 mg/1 mL), . Medications will be diluted with 5 mL of normal saline solution slowly intravenously injected (over 5 minutes). The associate clinical research coordinator was responsible for preparation and dispensing the study drug. The investigators, treating physicians, nurses, and patients were blinded to the treatment.
Placebo
For the intervention, patients will be randomly allocated into three groups. Each patient will be randomized to one of three treatment groups:Placebo . Medications will be diluted with 5 mL of normal saline solution slowly intravenously injected (over 5 minutes). The associate clinical research coordinator was responsible for preparation and dispensing the study drug. The investigators, treating physicians, nurses, and patients were blinded to the treatment.