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

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Dental Anxiety; Heart Rate
• Intervention / Treatment: Drug: 100 mg of Valeriana officinalis L; Drug: Placebo 100mg

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Piracicaba, São Paulo, Brazil, 13414-903
      • Oral-Maxillofacial Surgery Sector of the Piracicaba Dental School, Universidade Estadual de Campinas (Brazil)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Valerian
Placebo Comparator: Placebo (100 mg); Placebo 100mg	Drug: Placebo 100mg; A single dose of 100 mg of placebo orally, 1 hour prior to surgical procedures

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri
• Collaborators: University of Campinas, Brazil
• Investigators: Principal Investigator: Marcos Pinheiro, PhD, Federal University of the Valleys of Jequitinhonha and Mucuri

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): August 1, 2003
• Study Completion (Actual): August 1, 2003

Study Registration Dates

• First Submitted: June 1, 2012
• First Submitted That Met QC Criteria: June 4, 2012
• First Posted (Estimate): June 5, 2012

Study Record Updates

• Last Update Posted (Estimate): June 6, 2012
• Last Update Submitted That Met QC Criteria: June 5, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: 098/2002