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

Blood Pressure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612130
• Other study ID #: 098/2002
• Status: Completed
• Phase: N/A
• First received: June 1, 2012
• Last updated: June 5, 2012
• Start date: March 2003
• Est. completion date: August 2003

Study information

• Verified date: June 2012
• Source: Federal University of the Valleys of Jequitinhonha and Mucuri
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Pressure
• Dental Anxiety
• Heart Rate

Intervention

Drug:
• 100 mg of Valeriana officinalis L
A single dose of 100 mg of Valeriana officinalis L., 1 hour prior to surgical procedures
• Placebo 100mg
A single dose of 100 mg of placebo orally, 1 hour prior to surgical procedures

Locations

Country	Name	City	State
Brazil	Oral-Maxillofacial Surgery Sector of the Piracicaba Dental School, Universidade Estadual de Campinas (Brazil)	Piracicaba	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of the Valleys of Jequitinhonha and Mucuri	University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	Oxygen saturation	Level of blood oxygen saturation 30 minutes after drug administration and throughout the surgical procedure.	1 day (During dental appointment)	No
Secondary	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	No