Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

The University of Texas System (UT)

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain; Dental Pain

Treatments: Drug: TAC alternate gel; Drug: benzocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00846690

HSC-DB-08-0484

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

Benzocaine

Active Comparator group

Description:

serves as "active" control

Treatment:

Drug: benzocaine

TAC

Experimental group

Description:

serves as comparator

Treatment:

Drug: TAC alternate gel