Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-27 @ 3:15 PM
Study NCT ID:
NCT01784250
Status:
UNKNOWN
Last Update Posted:
2013-02-05
First Post:
2013-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Clonidine and Propranolol in Dentistry (AAA)
Sponsor:
CES University
Organization:
Study Overview
Official Title:
Efficacy of Clonidine and Propranolol Versus Placebo for the Control of Anxiety During Surgical Procedures in Dentistry
Status:
UNKNOWN
Status Verified Date:
2013-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: