Efficacy of Clonidine and Propranolol in Dentistry (AAA)

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Efficacy of Clonidine and Propranolol Versus Placebo for the Control of Anxiety During Surgical Procedures in Dentistry

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Drug: Clonidine
* Drug: Propranolol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propanolol<br>Propranolol 40mg tablets, one tablet administered 1 hour before surgery | Drug: Propranolol<br>* Propranolol 40 mg tablet single dose, to receive by mouth one hour before surgery<br>* Other names: Inderal;|
| Placebo Comparator: Placebo<br>Placebo tablets, one tablet administered 1 hour before surgery | Drug: Placebo<br>* Sugar pill manufactured to mimic a drug<br>|
| Experimental: Clonidine<br>clonidine 150mcg tablets, one tablet administered 1 hour before surgery | Drug: Clonidine<br>* Clonidine 150 mcg tablet single dose, to receive by mouth one hour before surgery<br>* Other names: Catapresan;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | (plus or minus 4 hours) after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Verbal Numerical Rating Scale (VNRS) at three, six, and twenty-four hours post treatment |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clonidine, Propranolol, Third molar, Anxiety