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

Study Overview
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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.

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.

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

Conditions
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Dental Anxiety, Blood Pressure, Heart Rate

Intervention / Treatment
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* Drug: 100 mg of Valeriana officinalis L
* Drug: Placebo 100mg


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valeriana officinalis L (100mg)<br>100 mg of Valeriana officinalis L. (Valerian) | Drug: 100 mg of Valeriana officinalis L<br>* A single dose of 100 mg of Valeriana officinalis L., 1 hour prior to surgical procedures<br>* Other names: Valerian;|
| Placebo Comparator: Placebo (100 mg)<br>Placebo 100mg | Drug: Placebo 100mg<br>* A single dose of 100 mg of placebo orally, 1 hour prior to surgical procedures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs and symptoms of anxiety | 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 | 1 day (during dental appointment) | 
| assessment of the blood pressure | The assessment of the blood pressure was performed at three moments: baseline, post-medication and end of surgery. | 1 day (during dental appointment) | 
| Assesment of heart rate | The assessment of the heart rate was performed at three moments: baseline, post-medication and end of surgery. | 1 day (during dental appointment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen saturation | Level of blood oxygen saturation 30 minutes after drug administration and throughout the surgical procedure. | 1 day (During dental appointment) | 
| Side effects of drugs | 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. | 1 week |