Efficacy of Clonidine and Propranolol in Dentistry (AAA)

NCT ID: NCT01784250

Last Updated: 2013-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-04-30

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Propanolol

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

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

Propranolol 40 mg tablet single dose, to receive by mouth one hour before surgery

Placebo

Placebo tablets, one tablet administered 1 hour before surgery

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sugar pill manufactured to mimic a drug

Clonidine

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

Group Type: EXPERIMENTAL

Clonidine

Intervention Type: DRUG

Clonidine 150 mcg tablet single dose, to receive by mouth one hour before surgery

Interventions

Clonidine

Clonidine 150 mcg tablet single dose, to receive by mouth one hour before surgery

Intervention Type: DRUG

Propranolol

Propranolol 40 mg tablet single dose, to receive by mouth one hour before surgery

Intervention Type: DRUG

Placebo

Sugar pill manufactured to mimic a drug

Intervention Type: DRUG

Other Intervention Names

Catapresan; Artensol; Inderal

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CES University

OTHER

Sponsor Role: lead

Responsible Party

Patricia Bermúdez Reyes

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Bermudez, Dentistry

Role: PRINCIPAL_INVESTIGATOR

CES University

Libia M Rodriguez, Magister

Role: STUDY_DIRECTOR

CES University

Ana K Tamara, Physician

Role: PRINCIPAL_INVESTIGATOR

CES University

Locations

Cooperative University

Envigado, Antioquia, Colombia

Site Status: RECRUITING

Countries

Colombia

Facility Contacts

Patricia Bermudez, Dentistry

Role: primary

patvanss@hotmail.com

Ana K Tamara, Physician

Role: backup

anakarinatamarae@hotmail.com

References

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.

Reference Type: BACKGROUND

PMID: 19145721 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15239776 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19913724 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19709436 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16931871 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1918581 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15218405 (View on PubMed)

Other Identifiers

CLON000

Identifier Type: -

Identifier Source: org_study_id