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

This study has been completed.
Sponsor:
Collaborator:
University of Campinas, Brazil
Information provided by (Responsible Party):
Marcos Luciano Pimenta Pinheiro, Federal University of the Valleys of Jequitinhonha and Mucuri
ClinicalTrials.gov Identifier:
NCT01612130
First received: June 1, 2012
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Dental Anxiety
Blood Pressure
Heart Rate
Drug: 100 mg of Valeriana officinalis L
Drug: Placebo 100mg

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

Resource links provided by NLM:


Further study details as provided by Federal University of the Valleys of Jequitinhonha and Mucuri:

Primary Outcome Measures:
  • Signs and symptoms of anxiety [ Time Frame: 1 day (during dental appointment) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    The assessment of the heart rate was performed at three moments: baseline, post-medication and end of surgery.


Secondary Outcome Measures:
  • Oxygen saturation [ Time Frame: 1 day (During dental appointment) ] [ Designated as safety issue: No ]
    Level of blood oxygen saturation 30 minutes after drug administration and throughout the surgical procedure.

  • Side effects of drugs [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: March 2003
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Placebo 100mg
Drug: Placebo 100mg
A single dose of 100 mg of placebo orally, 1 hour prior to surgical procedures

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612130

Locations
Brazil
Oral-Maxillofacial Surgery Sector of the Piracicaba Dental School, Universidade Estadual de Campinas (Brazil)
Piracicaba, São Paulo, Brazil, 13414-903
Sponsors and Collaborators
Federal University of the Valleys of Jequitinhonha and Mucuri
University of Campinas, Brazil
Investigators
Principal Investigator: Marcos Pinheiro, PhD Federal University of the Valleys of Jequitinhonha and Mucuri
  More Information

No publications provided

Responsible Party: Marcos Luciano Pimenta Pinheiro, Professor of Pharmacology and Therapeutics, Department of Basic Science, Biologic and Health Sciences Faculty, Federal University of Vales do Jequitinhonha e Mucuri - UFVJM, Diamantina, Minas Gerais, Brazil., Federal University of the Valleys of Jequitinhonha and Mucuri
ClinicalTrials.gov Identifier: NCT01612130     History of Changes
Other Study ID Numbers: 098/2002
Study First Received: June 1, 2012
Last Updated: June 5, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014