Efficacy of Clonidine and Propranolol in Dentistry (AAA)

CES University

Status and phase: Unknown; Phase 2

Conditions: Anxiety

Treatments: Drug: Placebo; Drug: Clonidine; Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01784250

CLON000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 14 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Propanolol

Experimental group

Description:

Propranolol 40mg tablets, one tablet administered 1 hour before surgery

Treatment:

Drug: Propranolol

Placebo

Placebo Comparator group

Description:

Placebo tablets, one tablet administered 1 hour before surgery

Treatment:

Drug: Placebo

Clonidine

Experimental group

Description:

clonidine 150mcg tablets, one tablet administered 1 hour before surgery

Treatment:

Drug: Clonidine