Rafael Soares da Cunha1, Klinger Souza Amorim2, Anne Caroline Gercina3, Allan Carlos Araújo de Oliveira1, Liciane Dos Santos Menezes1, Francisco Carlos Groppo3, Liane Maciel Almeida Souza1. 1. Oral Surgery and Anesthesiology Area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil. 2. Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, Av. Limeira, 901, Areião, Piracicaba, São Paulo, 13414-903, Brazil. klinger.amorim@outlook.com. 3. Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, Av. Limeira, 901, Areião, Piracicaba, São Paulo, 13414-903, Brazil.
Abstract
OBJECTIVES: This study aimed to compare the effects of Passiflora incarnata, Erythrina mulungu, and midazolam in controlling anxiety in patients undergoing mandibular third molar extraction. METHODS: The volunteers underwent extraction of their third mandibular molars in a randomized, placebo-controlled, triple-blind, and parallel clinical trial. Passiflora incarnata (500 mg), Erythrina mulungu (500 mg), or midazolam (15 mg) was orally administered 60 min before the surgery. The anxiety level of participants was evaluated using questionnaires and measurements of physical parameters, including heart rate (HR), blood pressure (BP), and oxygen saturation (SpO2). RESULTS: A total of 200 volunteers were included in this clinical trial. Considering each procedure independently, no significant differences (p > 0.05) in BP, HR, and SpO2 were observed among the protocols. CONCLUSIONS: Passiflora incarnata showed a similar effect to midazolam but differed from placebo and mulungu, which were unable to control anxiety in this situation. Therefore, the results suggest that Passiflora configures an herbal medicine with an anxiolytic effect, adequate to use in third molar extractions. CLINICAL RELEVANCE: The use of Passiflora incarnata may be an alternative to benzodiazepines for controlling anxiety in patients scheduled for oral surgery under local anesthesia. TRIAL REGISTRATION: ClinicalTrials.gov : ANSI-388.427.
RCT Entities:
OBJECTIVES: This study aimed to compare the effects of Passiflora incarnata, Erythrina mulungu, and midazolam in controlling anxiety in patients undergoing mandibular third molar extraction. METHODS: The volunteers underwent extraction of their third mandibular molars in a randomized, placebo-controlled, triple-blind, and parallel clinical trial. Passiflora incarnata (500 mg), Erythrina mulungu (500 mg), or midazolam (15 mg) was orally administered 60 min before the surgery. The anxiety level of participants was evaluated using questionnaires and measurements of physical parameters, including heart rate (HR), blood pressure (BP), and oxygen saturation (SpO2). RESULTS: A total of 200 volunteers were included in this clinical trial. Considering each procedure independently, no significant differences (p > 0.05) in BP, HR, and SpO2 were observed among the protocols. CONCLUSIONS:Passiflora incarnata showed a similar effect to midazolam but differed from placebo and mulungu, which were unable to control anxiety in this situation. Therefore, the results suggest that Passiflora configures an herbal medicine with an anxiolytic effect, adequate to use in third molar extractions. CLINICAL RELEVANCE: The use of Passiflora incarnata may be an alternative to benzodiazepines for controlling anxiety in patients scheduled for oral surgery under local anesthesia. TRIAL REGISTRATION: ClinicalTrials.gov : ANSI-388.427.
Entities:
Keywords:
Anxiety; Erythrina mulungu; Midazolam; Passiflora incarnata; Third molar