Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Unknown status

CT.gov ID

NCT00846690

Collaborator

(none)

Enrollment

Location

Arms

3.9

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2009

Anticipated Primary Completion Date :

Mar 1, 2009

Anticipated Study Completion Date :

May 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Benzocaine

serves as "active" control

Drug: benzocaine

20% benzocaine., topical placement onto site, minimal amount, for 1 minute

Other Names:

Hurricaine

Experimental: TAC

serves as comparator

Drug: TAC alternate gel

use 1 pump, place topically onto site, leave for 1-3 minutes

Other Names:

20% TAC alternate gel

Outcome Measures

Primary Outcome Measures

visual analogue scale score [pre-op, insertion, every minute post-op for 10 minutes]

Secondary Outcome Measures

blood pressure [three times pre-op, insertion, ten times post-op]
oxygen saturation [three times pre-op, insertion, ten times post-op]
heart rate [three times pre-op, insertion, ten times post-op]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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