Three Anxiolytic Drugs Used in Third Molar Surgery
Palabras clave
Abstracto
Descripción
In this research, characterized as a randomized, double-blind, parallel study, 200 healthy volunteered patients aging 18 or older will be distributed into 4 groups (n=50) as follows: Group I - 500mg Erythrina mulungu; Group II - placebo; Group III ; 100 mg Passiflora incarnata; Group IV - 15 mg midazolam. All treatments will be administered p.o. 1 hour randomly prior to the surgical procedures. The level of anxiety will be assessed through questionnaires and physical parameters, such as blood pressure, heart rate and oxygen concentration in three periods: at baseline, right before the surgical procedures and after 7 days. Data will be collected, tabulated and analyzed by the following statistical tests: chi-square, t-test, ANOVA and Tukey test, Friedman, Fisher's exact test with significance level of 5%.
fechas
| Verificado por última vez: | 09/30/2016 |
| Primero enviado: | 02/14/2014 |
| Inscripción estimada enviada: | 02/14/2014 |
| Publicado por primera vez: | 02/18/2014 |
| Última actualización enviada: | 10/25/2016 |
| Última actualización publicada: | 10/27/2016 |
| Fecha de inicio real del estudio: | 02/28/2014 |
| Fecha estimada de finalización primaria: | 03/31/2014 |
| Fecha estimada de finalización del estudio: | 08/31/2014 |
Condición o enfermedad
Intervención / tratamiento
Drug: Mulungu
Drug: placebo
Drug: Passiflora incarnata
Drug: midazolam
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: Mulungu 500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure. | Drug: Mulungu 500 mg/single dose/1 hour before dental surgery |
| Placebo Comparator: placebo 500 mg of starch (2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure. | Drug: placebo 500 mg/single dose/1 hour before dental surgery |
| Active Comparator: Passiflora incarnata 100 mg Passiflora incarnata (2 capsules of 50 mg) to be administered v.o., one hour before the surgical procedure. | Drug: Passiflora incarnata 100 mg/single dose/1 hour before dental surgery |
| Active Comparator: midazolam 15 mg midazolam (2 capsules of 7.5 mg) to be administered v.o., one hour before the surgical procedure. | Drug: midazolam 15 mg/single dose/1 hour before dental surgery |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - indication of bilateral extraction of asymptomatic, impacted mandibular third molars Exclusion Criteria: - patients under the age of 18 any general health problem based on the medical history and physical examination history of use of any medication within 15 days before the beginning of the research history of hypersensitivity to drugs, substances or materials used in this experiment pregnancy or lactation history of pericoronitis |
Salir
Medidas de resultado primarias
1. Changes in anxiety report [Change from baseline to 7 days]
Medidas de resultado secundarias
1. Changes in blood pressure [Change from baseline to 2 hours]
2. Changes in heart rate [Change from baseline to 2 hours]
3. Changes in oxygen saturation [Change from baseline to 2 hours]
