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Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

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ClinicalTrials.gov Identifier: NCT00846690
Recruitment Status : Unknown
Verified February 2009 by The University of Texas Health Science Center, Houston.
Recruitment status was:  Recruiting
First Posted : February 19, 2009
Last Update Posted : February 19, 2009
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston

Study Description
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Brief Summary:
The project is a study comparing the effectiveness of two topical anesthetics for control of pain associated with dental needle insertion in the palatal mucosa. A standard dental topical anesthetic (20% benzocaine) will serve as an "active" control and will be compared to a combination topical anesthetic, consisting of 20% lidocaine, 4% tetracaine and 2% phenylephrine (TAC Alternate Gel, Compounding Arts Pharmacy, Lafayette, LA).

Condition or disease Intervention/treatment Phase
Dental Pain Postoperative Pain Drug: benzocaine Drug: TAC alternate gel Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel for Control of Pain of Dental Needle Insertion in the Palate
Study Start Date : January 2009
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Benzocaine
serves as "active" control
 Drug: benzocaine
20% benzocaine., topical placement onto site, minimal amount, for 1 minute
Other Name: Hurricaine
Experimental: TAC
serves as comparator
 Drug: TAC alternate gel
use 1 pump, place topically onto site, leave for 1-3 minutes
Other Name: 20% TAC alternate gel


Outcome Measures
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Primary Outcome Measures :
  1. visual analogue scale score [ Time Frame: pre-op, insertion, every minute post-op for 10 minutes ]

Secondary Outcome Measures :
  1. blood pressure [ Time Frame: three times pre-op, insertion, ten times post-op ]
  2. oxygen saturation [ Time Frame: three times pre-op, insertion, ten times post-op ]
  3. heart rate [ Time Frame: three times pre-op, insertion, ten times post-op ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Volunteers 18 years or older
  2. Ability to consent to participate in the research
  3. Ability to communicate a VAS score
  4. Generally healthy, ASA I and ASA II
  5. No known drug allergies
  6. Ability to tolerate pulse oximeter and blood pressure cuff without psychological, or physiological consequence

Exclusion Criteria:

  1. Allergy or other contraindications to the topical anesthetics
  2. Inability to consent to participation in the study
  3. Use of analgesics prior to the procedure
  4. Vulnerable populations
Contacts and Locations
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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): NCT00846690


Contacts
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Contact: Femme L Ambrosio, DDS 858 603-6345 femme.l.ambrosio@uth.tmc.edu
Contact: Arthur H Jeske, DDS, PhD 713 500 4506 arthur.h.jeske@uth.tmc.edu

Locations
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United States, Texas
UT Pediatric Dentistry Clinic Houston Medical Center Recruiting
6655 Travis Suite 460, Texas, United States, 77030
Contact: Femme L Ambrosio, DDS    858-603-6345    femme.l.ambrosio@uth.tmc.edu   
Contact: Arthur H Jeske, DDS PhD    7135004506    arthur.h.jeske@uth.tmc.edu   
Sub-Investigator: Robert Tate, DDS MS         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Femme L Ambrosio, DDS UT Health Science Center Houston
Study Chair: Arthur H Jeske, DDS, PhD UT Health Science Center Houston
More Information
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Responsible Party: Femme Ambrosio, University of Texas Health Science Center Houston
ClinicalTrials.gov Identifier: NCT00846690    
Other Study ID Numbers: HSC-DB-08-0484
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: February 19, 2009
Last Verified: February 2009
Keywords provided by The University of Texas Health Science Center, Houston:
topical anesthetics
topical anesthesia
20% benzocaine
 TAC alternate gel
combination topical anesthetics
dental anesthesia
Additional relevant MeSH terms:
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Toothache
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Lidocaine
Phenylephrine
Benzocaine
Tetracaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Mydriatics
Autonomic Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants