Dental Anxiety, Blood Pressure, Heart Rate
Conditions
Brief summary
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
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.
Interventions
DRUG100 mg of Valeriana officinalis L
A single dose of 100 mg of Valeriana officinalis L., 1 hour prior to surgical procedures
DRUGPlacebo 100mg
A single dose of 100 mg of placebo orally, 1 hour prior to surgical procedures
Sponsors
University of Campinas, Brazil
Federal University of the Valleys of Jequitinhonha and Mucuri
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Signs and symptoms of anxiety | 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 |
| assessment of the blood pressure | 1 day (during dental appointment) | The assessment of the blood pressure was performed at three moments: baseline, post-medication and end of surgery. |
| Assesment of heart rate | 1 day (during dental appointment) | The assessment of the heart rate was performed at three moments: baseline, post-medication and end of surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen saturation | 1 day (During dental appointment) | Level of blood oxygen saturation 30 minutes after drug administration and throughout the surgical procedure. |
| Side effects of drugs | 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. |
Countries
Brazil
Outcome results
None listed