NCT01784250

Efficacy of Clonidine and Propranolol in Dentistry (AAA)

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: CES University · Academic / Other
• Sex: All
• Age: 14 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anxiety

Interventions

Type	Name	Description
DRUG	Clonidine	Clonidine 150 mcg tablet single dose, to receive by mouth one hour before surgery
DRUG	Propranolol	Propranolol 40 mg tablet single dose, to receive by mouth one hour before surgery
DRUG	Placebo	Sugar pill manufactured to mimic a drug

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2013-02-05
• Last updated: 2013-02-05

Locations

1 site across 1 country: Colombia