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

NCT01612130 | Completed

• 1 other identifier: 098/2002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety; Blood Pressure; Heart Rate

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Oxygen saturation

  1 day (During dental appointment)

• Side effects of drugs

  1 week

Study Arms (2)

Valeriana officinalis L (100mg)

EXPERIMENTAL

100 mg of Valeriana officinalis L. (Valerian)

Drug: 100 mg of Valeriana officinalis L

Placebo (100 mg)

PLACEBO COMPARATOR

Placebo 100mg

Drug: Placebo 100mg

Interventions

100 mg of Valeriana officinalis L DRUG

A single dose of 100 mg of Valeriana officinalis L., 1 hour prior to surgical procedures

Also known as: Valerian

Valeriana officinalis L (100mg)

Placebo 100mg DRUG

A single dose of 100 mg of placebo orally, 1 hour prior to surgical procedures

Placebo (100 mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for bilateral extraction of asymptomatic impacted mandibular third molars in similar positions based on the Pell \& Gregory classification

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of the Valleys of Jequitinhonha and Mucuri: lead
• University of Campinas, Brazil: collaborator

Study Sites (1)

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

Piracicaba, São Paulo, 13414-903, Brazil

Location

MeSH Terms

Interventions

Valeriana extract

Study Officials

• Marcos Pinheiro, PhD

  Federal University of the Valleys of Jequitinhonha and Mucuri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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.

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 5, 2012
• Study Start: March 1, 2003
• Primary Completion: August 1, 2003
• Study Completion: August 1, 2003
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

BR (1)