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

Primary Purpose

Dental Anxiety, Blood Pressure, Heart Rate

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
100 mg of Valeriana officinalis L
Placebo 100mg
Sponsored by
Federal University of the Valleys of Jequitinhonha and Mucuri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Valeriana officinalis L (100mg)

Placebo (100 mg)

Arm Description

100 mg of Valeriana officinalis L. (Valerian)

Placebo 100mg

Outcomes

Primary Outcome Measures

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
assessment of the blood pressure
The assessment of the blood pressure was performed at three moments: baseline, post-medication and end of surgery.
Assesment of heart rate
The assessment of the heart rate was performed at three moments: baseline, post-medication and end of surgery.

Secondary Outcome Measures

Oxygen saturation
Level of blood oxygen saturation 30 minutes after drug administration and throughout the surgical procedure.
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.

Full Information

First Posted
June 1, 2012
Last Updated
June 5, 2012
Sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri
Collaborators
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01612130
Brief Title
Valerian for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri
Collaborators
University of Campinas, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety, Blood Pressure, Heart Rate

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valeriana officinalis L (100mg)
Arm Type
Experimental
Arm Description
100 mg of Valeriana officinalis L. (Valerian)
Arm Title
Placebo (100 mg)
Arm Type
Placebo Comparator
Arm Description
Placebo 100mg
Intervention Type
Drug
Intervention Name(s)
100 mg of Valeriana officinalis L
Other Intervention Name(s)
Valerian
Intervention Description
A single dose of 100 mg of Valeriana officinalis L., 1 hour prior to surgical procedures
Intervention Type
Drug
Intervention Name(s)
Placebo 100mg
Intervention Description
A single dose of 100 mg of placebo orally, 1 hour prior to surgical procedures
Primary Outcome Measure Information:
Title
Signs and symptoms of anxiety
Description
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
Time Frame
1 day (during dental appointment)
Title
assessment of the blood pressure
Description
The assessment of the blood pressure was performed at three moments: baseline, post-medication and end of surgery.
Time Frame
1 day (during dental appointment)
Title
Assesment of heart rate
Description
The assessment of the heart rate was performed at three moments: baseline, post-medication and end of surgery.
Time Frame
1 day (during dental appointment)
Secondary Outcome Measure Information:
Title
Oxygen saturation
Description
Level of blood oxygen saturation 30 minutes after drug administration and throughout the surgical procedure.
Time Frame
1 day (During dental appointment)
Title
Side effects of drugs
Description
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.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcos Pinheiro, PhD
Organizational Affiliation
Federal University of the Valleys of Jequitinhonha and Mucuri
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oral-Maxillofacial Surgery Sector of the Piracicaba Dental School, Universidade Estadual de Campinas (Brazil)
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
13414-903
Country
Brazil

12. IPD Sharing Statement

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

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