Efficacy of Clonidine and Propranolol Versus Placebo for the Control of Anxiety During Surgical Procedures in Dentistry
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in modified dental anxiety scale(MDAS)and vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation) until four hours post treatment
研究概览
简要总结
The aim of the study is to determine the efficacy of clonidine and propranolol for transient anxiety management and intra and postoperative pain in patients undergoing ambulatory surgery of third molar.
详细描述
There will be a randomized, triple-blind, placebo-controlled clinical trial with parallel group design to determine the efficacy of the pre medication propranolol and clonidine versus placebo for reducing anxiety during third molar removal surgery. Patients will be assigned to 3 groups of 20 patients each. One group will receive 150 mcg of clonidine, the second group will receive propranolol 40mg, and the control group will receive placebo. The modified dental anxiety scale will be applied before and after surgery in order to evaluate the change in anxiety level, which will be assessed as the primary outcome. The secondary outcomes include the measurement of changes in blood pressure, heart rate and respiratory rate evaluated before, during and after surgery. Additionally, pain will be assessed through numerical pain scale at 3, 6 and 24 hours after surgery. Also, possible side effects will be identified (vomiting, nausea, dry mouth, dizziness and drowsiness). Statistical analysis: qualitative variables will be described by absolute and relative frequencies, and quantitative variables will be described by the mean along with standard deviation or the median with interquartile range depending on the distribution of the data. One-way ANOVA or Kruskal Wallis will be used (depending on the fulfillment of assumptions) in order to compare the quantitative variables amongst the groups. The chi squared test will be used to compare the qualitative variables. The confidence intervals will be estimated at 95% for all effect magnitude measurements calculated.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normotensive patients and pre-hypertension who are undergoing elective surgery for removal of third molars.
- •Age range 14 to 40 years
- •Patients with dental anxiety above 13 points on the scale (MDAS).
- •People who voluntarily agree to participate in the study and sign the informed consent form
排除标准
- •Patients receiving any medication for any chronic pathology.
- •Patients of African American race, being more likely to have abnormal blood pressure.
- •Patients with a history of cardiovascular disease.
- •Patients with chronic systemic disease such as diabetes, hyper or hypothyroidism, Addison's syndrome, renal failure, hypertension or liver disease.
- •Pregnant or breastfeeding.
- •Patients diagnosed with anxiety disorder or depressive disorder
研究组 & 干预措施
Propanolol
Propranolol 40mg tablets, one tablet administered 1 hour before surgery
干预措施: Propranolol (Drug)
Placebo
Placebo tablets, one tablet administered 1 hour before surgery
干预措施: Placebo (Drug)
Clonidine
clonidine 150mcg tablets, one tablet administered 1 hour before surgery
干预措施: Clonidine (Drug)
结局指标
主要结局
Change from baseline in modified dental anxiety scale(MDAS)and vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation) until four hours post treatment
时间窗: (plus or minus 4 hours) after surgery
次要结局
- Changes in Verbal Numerical Rating Scale (VNRS) at three, six, and twenty-four hours post treatment(24 hours)
研究者
Patricia Bermúdez Reyes
Researcher
CES University