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Efficacy of Clonidine and Propranolol in Dentistry (AAA)

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ClinicalTrials.gov Identifier: NCT01784250
Recruitment Status : Unknown
Verified February 2013 by Patricia Bermúdez Reyes, CES University.
Recruitment status was:  Recruiting
First Posted : February 5, 2013
Last Update Posted : February 5, 2013
Sponsor:
Information provided by (Responsible Party):
Patricia Bermúdez Reyes, CES University

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.

Condition or disease Intervention/treatment Phase
Anxiety Drug: Clonidine Drug: Propranolol Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Clonidine and Propranolol Versus Placebo for the Control of Anxiety During Surgical Procedures in Dentistry
Study Start Date : August 2012
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Propanolol
Propranolol 40mg tablets, one tablet administered 1 hour before surgery
Drug: Propranolol
Propranolol 40 mg tablet single dose, to receive by mouth one hour before surgery
Other Names:
  • Artensol
  • Inderal

Placebo Comparator: Placebo
Placebo tablets, one tablet administered 1 hour before surgery
Drug: Placebo
Sugar pill manufactured to mimic a drug

Experimental: Clonidine
clonidine 150mcg tablets, one tablet administered 1 hour before surgery
Drug: Clonidine
Clonidine 150 mcg tablet single dose, to receive by mouth one hour before surgery
Other Name: Catapresan




Primary Outcome Measures :
  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 [ Time Frame: (plus or minus 4 hours) after surgery ]

Secondary Outcome Measures :
  1. Changes in Verbal Numerical Rating Scale (VNRS) at three, six, and twenty-four hours post treatment [ Time Frame: 24 hours ]

Other Outcome Measures:
  1. Frequency of side effects in patients treated with clonidine and propranolol compared with placebo after third molar surgery [ Time Frame: 24 hours ]


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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784250


Locations
Colombia
Cooperative University Recruiting
Envigado, Antioquia, Colombia
Contact: Patricia Bermudez, Dentistry       patvanss@hotmail.com   
Contact: Ana K Tamara, Physician       anakarinatamarae@hotmail.com   
Sponsors and Collaborators
CES University
Investigators
Principal Investigator: Patricia Bermudez, Dentistry CES University
Study Director: Libia M Rodriguez, Magister CES University
Principal Investigator: Ana K Tamara, Physician CES University

Publications:
Responsible Party: Patricia Bermúdez Reyes, Researcher, CES University
ClinicalTrials.gov Identifier: NCT01784250     History of Changes
Other Study ID Numbers: CLON000
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013

Keywords provided by Patricia Bermúdez Reyes, CES University:
Clonidine
Propranolol
Third molar
Anxiety

Additional relevant MeSH terms:
Clonidine
Anxiety Disorders
Mental Disorders
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists