Clinical TrialID 488

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

NCT01612130

Dental Anxiety|Blood Pressure|Heart Rate

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Record Fields

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Clinical Trial Id
488
Evidence Id
488
Core Evidence Id
488
Source Clinical Trial Id
470
Herb2 Clinical Trial Id
HBCT000470
Nct Id
NCT01612130
Title
Valerian for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery
Status
Completed
Phase
Study Result
No
Study Condition
Dental Anxiety|Blood Pressure|Heart Rate
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Intervention
DRUG: 100 mg of Valeriana officinalis L|DRUG: Placebo 100mg
Intervention Allocation
Randomized
Intervention Model
Crossover
Intervention Mask
Triple
Intervention Purpose
Prevention
Gender
All
Age
Adult, Older_Adult
Enrollment
20
Outcome Measure
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)
Sponsor Collaborator
Federal University of the Valleys of Jequitinhonha and Mucuri|University of Campinas, Brazil
Funded By
OTHER
Location
Oral-Maxillofacial Surgery Sector of the Piracicaba Dental School, Universidade Estadual de Campinas (Brazil), Piracicaba, São Paulo, 13414-903, Brazil
Other Id
098/2002
Start Date
2003-03
Primary Completion Date
2003-08
Completion Date
2003-08
First Posted
2012-06-05
Results First Posted
Last Update Posted
2012-06-06
Study Document
Study Url
https://clinicaltrials.gov/study/NCT01612130
Title Cn
Title En
Valerian for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery
Bilingual Status
semi_complete