Valerian for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2003-08-31

Brief Summary

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The aim of the present study was to evaluate the efficacy of Valeriana officinalis L. 100 mg in single oral doses one hour preoperative as conscious sedation during the impacted lower third molar surgery.

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Detailed Description

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Evaluate the efficacy of Valeriana officinalis L. (Valerian) for control of anxiety during third molar surgery. Study design: A single oral dose of either valerian (100 mg) or placebo was randomly administered one hour before each surgical procedure to 20 volunteers between 17 and 31 years of age. Anxiety level was assessed through questionnaires, physiological parameters (blood pressure and heart rate) and the observation of signs.

Conditions

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Dental Anxiety Blood Pressure Heart Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Valeriana officinalis L (100mg)

100 mg of Valeriana officinalis L. (Valerian)

Group Type EXPERIMENTAL

100 mg of Valeriana officinalis L

Intervention Type DRUG

A single dose of 100 mg of Valeriana officinalis L., 1 hour prior to surgical procedures

Placebo (100 mg)

Placebo 100mg

Group Type PLACEBO_COMPARATOR

Placebo 100mg

Intervention Type DRUG

A single dose of 100 mg of placebo orally, 1 hour prior to surgical procedures

Interventions

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100 mg of Valeriana officinalis L

A single dose of 100 mg of Valeriana officinalis L., 1 hour prior to surgical procedures

Intervention Type DRUG

Placebo 100mg

A single dose of 100 mg of placebo orally, 1 hour prior to surgical procedures

Intervention Type DRUG

Other Intervention Names

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Valerian

Eligibility Criteria

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Inclusion Criteria

* Indication for bilateral extraction of asymptomatic impacted mandibular third molars in similar positions based on the Pell \& Gregory classification

Exclusion Criteria

* Use of any type of medication in the 15 days prior to the onset of the study; history of hypersensitivity to the drugs, substances or materials employed in the experiment; pregnancy or lactation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Marcos Luciano Pimenta Pinheiro

Professor of Pharmacology and Therapeutics, Department of Basic Science, Biologic and Health Sciences Faculty, Federal University of Vales do Jequitinhonha e Mucuri - UFVJM, Diamantina, Minas Gerais, Brazil.

Responsibility Role PRINCIPAL_INVESTIGATOR