Valerian for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01612130|
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : June 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Dental Anxiety Blood Pressure Heart Rate||Drug: 100 mg of Valeriana officinalis L Drug: Placebo 100mg||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Valeriana Officinalis L. for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery: A Randomized, Double-Blind, Placebo-Controlled Crossover Study|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||August 2003|
|Actual Study Completion Date :||August 2003|
Experimental: Valeriana officinalis L (100mg)
100 mg of Valeriana officinalis L. (Valerian)
Drug: 100 mg of Valeriana officinalis L
A single dose of 100 mg of Valeriana officinalis L., 1 hour prior to surgical procedures
Other Name: Valerian
Placebo Comparator: Placebo (100 mg)
Drug: Placebo 100mg
A single dose of 100 mg of placebo orally, 1 hour prior to surgical procedures
- 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
- 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.
- 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.
- Oxygen saturation [ Time Frame: 1 day (During dental appointment) ]Level of blood oxygen saturation 30 minutes after drug administration and throughout the surgical procedure.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612130
|Oral-Maxillofacial Surgery Sector of the Piracicaba Dental School, Universidade Estadual de Campinas (Brazil)|
|Piracicaba, São Paulo, Brazil, 13414-903|
|Principal Investigator:||Marcos Pinheiro, PhD||Federal University of the Valleys of Jequitinhonha and Mucuri|