Efficacy of Clonidine and Propranolol in Dentistry (AAA)

NCT01784250 | Unknown Phase 2 DMC

• 1 other identifier: CLON000
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Clonidine; Propranolol; Third molar; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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

  (plus or minus 4 hours) after surgery

Secondary Outcomes (1)

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

  24 hours

Other Outcomes (1)

• Frequency of side effects in patients treated with clonidine and propranolol compared with placebo after third molar surgery

  24 hours

Study Arms (3)

Propanolol

EXPERIMENTAL

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

Drug: Propranolol

Placebo

PLACEBO COMPARATOR

Placebo tablets, one tablet administered 1 hour before surgery

Drug: Placebo

Clonidine

EXPERIMENTAL

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

Drug: Clonidine

Interventions

Clonidine DRUG

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

Also known as: Catapresan

Clonidine

Propranolol DRUG

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

Also known as: Artensol, Inderal

Propanolol

Placebo DRUG

Sugar pill manufactured to mimic a drug

Placebo

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CES University: lead

Study Sites (1)

Cooperative University

Envigado, Antioquia, Colombia

RECRUITING

Related Publications (7)

• 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.

  PMID: 19145721 BACKGROUND

• 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.

  PMID: 15239776 BACKGROUND

• 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.

  PMID: 19913724 BACKGROUND

• 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.

  PMID: 19709436 BACKGROUND

• 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.

  PMID: 16931871 BACKGROUND

• 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.

  PMID: 1918581 BACKGROUND

• 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.

  PMID: 15218405 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Clonidine; Propranolol

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Patricia Bermudez, Dentistry

  CES University

  PRINCIPAL INVESTIGATOR

• Libia M Rodriguez, Magister

  CES University

  STUDY DIRECTOR

• Ana K Tamara, Physician

  CES University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: February 5, 2013
• Study Start: August 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 5, 2013

Record last verified: 2013-02

Locations

CO (1)