Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Dental Pain Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Benzocaine

serves as "active" control

Group Type ACTIVE_COMPARATOR

benzocaine

Intervention Type DRUG

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

TAC

serves as comparator

Group Type EXPERIMENTAL

TAC alternate gel

Intervention Type DRUG

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

Interventions

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benzocaine

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

Intervention Type DRUG

TAC alternate gel

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

Intervention Type DRUG

Other Intervention Names

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Hurricaine 20% TAC alternate gel

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes