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

Not Applicable

Completed

• Conditions: Dental Anxiety; Blood Pressure; Heart Rate
• Interventions: Drug: 100 mg of Valeriana officinalis L; Drug: Placebo 100mg

• Registration Number: NCT01612130
• Lead Sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri

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.

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Status Verified: 2012-06
• Study First Submitted: 2012-06-01
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-05
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Valeriana officinalis L (100mg)	100 mg of Valeriana officinalis L	100 mg of Valeriana officinalis L. (Valerian)
Placebo (100 mg)	Placebo 100mg	Placebo 100mg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Oral-Maxillofacial Surgery Sector of the Piracicaba Dental School, Universidade Estadual de Campinas (Brazil); 🇧🇷 Piracicaba, São Paulo, Brazil