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| Name | Class |
|---|---|
| University of Campinas, Brazil | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valeriana officinalis L (100mg) | Experimental | 100 mg of Valeriana officinalis L. (Valerian) |
|
| Placebo (100 mg) | Placebo Comparator | Placebo 100mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100 mg of Valeriana officinalis L | Drug | A single dose of 100 mg of Valeriana officinalis L., 1 hour prior to surgical procedures |
|
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcos Pinheiro, PhD | Federal University of the Valleys of Jequitinhonha and Mucuri | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral-Maxillofacial Surgery Sector of the Piracicaba Dental School, Universidade Estadual de Campinas (Brazil) | Piracicaba | São Paulo | 13414-903 | Brazil |
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| ID | Term |
|---|---|
| C000713890 | Valeriana extract |
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| Placebo 100mg | Drug | A single dose of 100 mg of placebo orally, 1 hour prior to surgical procedures |
|
| 1 week |