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Completed

NCT Number: NCT01612130

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

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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Key information

Conditions

Dental Anxiety Blood Pressure Heart Rate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oral-Maxillofacial Surgery Sector of the Piracicaba Dental School, Universidade Estadual de Campinas (Brazil)

Piracicaba, São Paulo, 13414-903, Brazil

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

100 mg of Valeriana officinalis L

Drug

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

Other names: Valerian

Placebo 100mg

Drug

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

Primary outcomes

  1. Signs and symptoms of anxiety

    Time frame: 1 day (during dental appointment)

    During each surgery, the researcher and surgeon observed the manifestation of signs and symptoms associated to anxiety (restlessness/agitation/nervous ticks, paleness, excessive perspiration, tingling sensation in hands, feet or lips, change in breathing rhythm or depth). In the presence of one or more of these signs and symptoms, the patient was classified as anxious. If there was no manifestation of anxiety, the patient was classified as calm or relaxed

  2. assessment of the blood pressure

    Time frame: 1 day (during dental appointment)

    The assessment of the blood pressure was performed at three moments: baseline, post-medication and end of surgery.

  3. Assesment of heart rate

    Time frame: 1 day (during dental appointment)

    The assessment of the heart rate was performed at three moments: baseline, post-medication and end of surgery.

Secondary outcomes

  1. Oxygen saturation

    Time frame: 1 day (During dental appointment)

    Level of blood oxygen saturation 30 minutes after drug administration and throughout the surgical procedure.

  2. Side effects of drugs

    Time frame: 1 week

    Evaluation of the incidence of side effects of drugs used were informed by the patient after de drug administration until one week of postoperative period.

Sponsors and collaborators

Lead sponsor

Federal University of the Valleys of Jequitinhonha and Mucuri

Other

Collaborators

  • University of Campinas, Brazil

Registry information

Official study title

Valeriana Officinalis L. for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery: A Randomized, Double-Blind, Placebo-Controlled Crossover Study

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Jun 5, 2012
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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