Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

This study is currently recruiting participants.

Verified by The University of Texas Health Science Center, Houston, February 2009

First Received: February 18, 2009 No Changes Posted

Sponsored by:	The University of Texas Health Science Center, Houston
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00846690

Purpose

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	Intervention	Phase
Dental Pain Postoperative Pain	Drug: benzocaine Drug: TAC alternate gel	Phase IV

MedlinePlus related topics: Anesthesia

Drug Information available for: Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Crossover Assignment, Efficacy Study
Official Title:	Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel for Control of Pain of Dental Needle Insertion in the Palate

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

visual analogue scale score [ Time Frame: pre-op, insertion, every minute post-op for 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

blood pressure [ Time Frame: three times pre-op, insertion, ten times post-op ] [ Designated as safety issue: Yes ]
oxygen saturation [ Time Frame: three times pre-op, insertion, ten times post-op ] [ Designated as safety issue: Yes ]
heart rate [ Time Frame: three times pre-op, insertion, ten times post-op ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	January 2009
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Allergy or other contraindications to the topical anesthetics
Inability to consent to participation in the study
Use of analgesics prior to the procedure
Vulnerable populations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846690

Contacts

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

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

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

No publications provided

Responsible Party:	University of Texas Health Science Center Houston ( Femme Ambrosio )
Study ID Numbers:	HSC-DB-08-0484
Study First Received:	February 18, 2009
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00846690 History of Changes
Health Authority:	United States: Institutional Review Board

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

Study placed in the following topic categories:

Tooth Diseases
Facial Pain
Facies
Toothache
Benzocaine
Anesthetics
Central Nervous System Depressants

Pain
Anesthetics, Local
Signs and Symptoms
Postoperative Complications
Peripheral Nervous System Agents
Stomatognathic Diseases
Pain, Postoperative

Additional relevant MeSH terms:

Tooth Diseases
Facial Pain
Toothache
Physiological Effects of Drugs
Benzocaine
Anesthetics
Central Nervous System Depressants
Pain
Pharmacologic Actions
Anesthetics, Local

Signs and Symptoms
Pathologic Processes
Postoperative Complications
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Stomatognathic Diseases
Central Nervous System Agents
Pain, Postoperative

ClinicalTrials.gov processed this record on May 07, 2009