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Efficacy of Clonidine and Propranolol in Dentistry (AAA)

Primary Purpose

Anxiety

Status
Unknown status
Phase
Phase 2
Locations
Colombia
Study Type
Interventional
Intervention
Clonidine
Propranolol
Placebo
Sponsored by
CES University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Clonidine, Propranolol, Third molar, Anxiety

Eligibility Criteria

14 Years - 40 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Cooperative UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Propanolol

Placebo

Clonidine

Arm Description

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

Placebo tablets, one tablet administered 1 hour before surgery

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in Verbal Numerical Rating Scale (VNRS) at three, six, and twenty-four hours post treatment

Full Information

First Posted
January 23, 2013
Last Updated
February 2, 2013
Sponsor
CES University
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1. Study Identification

Unique Protocol Identification Number
NCT01784250
Brief Title
Efficacy of Clonidine and Propranolol in Dentistry (AAA)
Official Title
Efficacy of Clonidine and Propranolol Versus Placebo for the Control of Anxiety During Surgical Procedures in Dentistry
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CES University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Clonidine, Propranolol, Third molar, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propanolol
Arm Type
Experimental
Arm Description
Propranolol 40mg tablets, one tablet administered 1 hour before surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets, one tablet administered 1 hour before surgery
Arm Title
Clonidine
Arm Type
Experimental
Arm Description
clonidine 150mcg tablets, one tablet administered 1 hour before surgery
Intervention Type
Drug
Intervention Name(s)
Clonidine
Other Intervention Name(s)
Catapresan
Intervention Description
Clonidine 150 mcg tablet single dose, to receive by mouth one hour before surgery
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
Artensol, Inderal
Intervention Description
Propranolol 40 mg tablet single dose, to receive by mouth one hour before surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sugar pill manufactured to mimic a drug
Primary Outcome Measure Information:
Title
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
Time Frame
(plus or minus 4 hours) after surgery
Secondary Outcome Measure Information:
Title
Changes in Verbal Numerical Rating Scale (VNRS) at three, six, and twenty-four hours post treatment
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Frequency of side effects in patients treated with clonidine and propranolol compared with placebo after third molar surgery
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Bermudez, Dentistry
Organizational Affiliation
CES University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Libia M Rodriguez, Magister
Organizational Affiliation
CES University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ana K Tamara, Physician
Organizational Affiliation
CES University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cooperative University
City
Envigado
State/Province
Antioquia
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Bermudez, Dentistry
Email
patvanss@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ana K Tamara, Physician
Email
anakarinatamarae@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
19145721
Citation
Ng SK, Leung WK. A community study on the relationship of dental anxiety with oral health status and oral health-related quality of life. Community Dent Oral Epidemiol. 2008 Aug;36(4):347-56. doi: 10.1111/j.1600-0528.2007.00412.x.
Results Reference
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PubMed Identifier
15239776
Citation
Kvale G, Berggren U, Milgrom P. Dental fear in adults: a meta-analysis of behavioral interventions. Community Dent Oral Epidemiol. 2004 Aug;32(4):250-64. doi: 10.1111/j.1600-0528.2004.00146.x.
Results Reference
background
PubMed Identifier
19913724
Citation
Lago-Mendez L, Diniz-Freitas M, Senra-Rivera C, Seoane-Pesqueira G, Gandara-Rey JM, Garcia-Garcia A. Postoperative recovery after removal of a lower third molar: role of trait and dental anxiety. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Dec;108(6):855-60. doi: 10.1016/j.tripleo.2009.07.021.
Results Reference
background
PubMed Identifier
19709436
Citation
Humphris GM, Dyer TA, Robinson PG. The modified dental anxiety scale: UK general public population norms in 2008 with further psychometrics and effects of age. BMC Oral Health. 2009 Aug 26;9:20. doi: 10.1186/1472-6831-9-20.
Results Reference
background
PubMed Identifier
16931871
Citation
Hall DL, Tatakis DN, Walters JD, Rezvan E. Oral clonidine pre-treatment and diazepam/meperidine sedation. J Dent Res. 2006 Sep;85(9):854-8. doi: 10.1177/154405910608500915.
Results Reference
background
PubMed Identifier
1918581
Citation
Liu HH, Milgrom P, Fiset L. Effect of a beta-adrenergic blocking agent on dental anxiety. J Dent Res. 1991 Sep;70(9):1306-8. doi: 10.1177/00220345910700091401.
Results Reference
background
PubMed Identifier
15218405
Citation
Herr KA, Spratt K, Mobily PR, Richardson G. Pain intensity assessment in older adults: use of experimental pain to compare psychometric properties and usability of selected pain scales with younger adults. Clin J Pain. 2004 Jul-Aug;20(4):207-19. doi: 10.1097/00002508-200407000-00002.
Results Reference
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Efficacy of Clonidine and Propranolol in Dentistry (AAA)

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