Comparative Study of the Effectiveness of Three Anxiolytic Drugs Used in Third Molar Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in anxiety report
研究概览
简要总结
This study was to compare the effectiveness of three drugs (Passiflora incarnata, Erythrina mulungum, Midazolam) in controlling anxiety in patients undergoing bilateral extraction of asymptomatic, impacted mandibular third molars.
详细描述
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%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •indication of bilateral extraction of asymptomatic, impacted mandibular third molars
排除标准
- •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
研究组 & 干预措施
Mulungu
500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure.
干预措施: Mulungu (Drug)
placebo
500 mg of starch (2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure.
干预措施: Placebo (Drug)
Passiflora incarnata
100 mg Passiflora incarnata (2 capsules of 50 mg) to be administered v.o., one hour before the surgical procedure.
干预措施: Passiflora incarnata (Drug)
midazolam
15 mg midazolam (2 capsules of 7.5 mg) to be administered v.o., one hour before the surgical procedure.
干预措施: midazolam (Drug)
结局指标
主要结局
Changes in anxiety report
时间窗: Change from baseline to 7 days
Changes in the subjects' anxiety level will be observed by using a Modified Corah Dental Anxiety Scale in three times: at baseline, in the day of surgery and after 7 days of the procedure.
次要结局
- Changes in blood pressure(Change from baseline to 2 hours)
- Changes in heart rate(Change from baseline to 2 hours)
- Changes in oxygen saturation(Change from baseline to 2 hours)
研究者
Liane Maciel de Almeida Souza
Professor
Universidade Federal de Sergipe