Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

Phase 4

• Conditions: Postoperative Pain; Dental Pain
• Interventions: Drug: benzocaine; Drug: TAC alternate gel

• Registration Number: NCT00846690
• Lead Sponsor: The University of Texas Health Science Center, Houston

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Status Verified: 2009-02
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-18
• Last Update Submitted: 2009-02-18
• Study First Posted: 2009-02-19
• Last Update Posted: 2009-02-19
• Primary Completion: 2009-03
• Study Completion: 2009-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Benzocaine	benzocaine	serves as "active" control
TAC	TAC alternate gel	serves as comparator

Primary Outcome Measures

Name	Time	Method
visual analogue scale score	pre-op, insertion, every minute post-op for 10 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UT Pediatric Dentistry Clinic Houston Medical Center; 🇺🇸 6655 Travis Suite 460, Texas, United States