Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

NCT00846690 | Unknown Phase 4

• 1 other identifier: HSC-DB-08-0484
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Pain; Postoperative Pain

Keywords

topical anesthetics; topical anesthesia; 20% benzocaine; TAC alternate gel; combination topical anesthetics; dental anesthesia

Outcome Measures

Primary Outcomes (1)

• visual analogue scale score

  pre-op, insertion, every minute post-op for 10 minutes

Secondary Outcomes (3)

• 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

Study Arms (2)

Benzocaine

ACTIVE COMPARATOR

serves as "active" control

Drug: benzocaine

TAC

EXPERIMENTAL

serves as comparator

Drug: TAC alternate gel

Interventions

benzocaine DRUG

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

Also known as: Hurricaine

Benzocaine

TAC alternate gel DRUG

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

Also known as: 20% TAC alternate gel

TAC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

UT Pediatric Dentistry Clinic Houston Medical Center

6655 Travis Suite 460, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Toothache; Pain, Postoperative

Interventions

Benzocaine

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Femme L Ambrosio, DDS

  UT Health Science Center Houston

  PRINCIPAL INVESTIGATOR

• Arthur H Jeske, DDS, PhD

  UT Health Science Center Houston

  STUDY CHAIR

Central Study Contacts

Femme L Ambrosio, DDS

CONTACT

858 603-6345; femme.l.ambrosio@uth.tmc.edu

Arthur H Jeske, DDS, PhD

CONTACT

713 500 4506; arthur.h.jeske@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 19, 2009
• Study Start: January 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: May 1, 2009
• Last Updated: February 19, 2009

Record last verified: 2009-02

Locations

US (1)