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Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by The University of Texas Health Science Center, Houston.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00846690
First received: February 18, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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 Intervention Phase
Dental Pain
Postoperative Pain
 Drug: benzocaine
Drug: TAC alternate gel
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • visual analogue scale score [ Time Frame: pre-op, insertion, every minute post-op for 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood pressure [ Time Frame: three times pre-op, insertion, ten times post-op ] [ Designated as safety issue: Yes ]
  • oxygen saturation [ Time Frame: three times pre-op, insertion, ten times post-op ] [ Designated as safety issue: Yes ]
  • heart rate [ Time Frame: three times pre-op, insertion, ten times post-op ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Benzocaine
serves as "active" control
 Drug: benzocaine
20% benzocaine., topical placement onto site, minimal amount, for 1 minute
Other Name: Hurricaine
Experimental: TAC
serves as comparator
 Drug: TAC alternate gel
use 1 pump, place topically onto site, leave for 1-3 minutes
Other Name: 20% TAC alternate gel

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846690

Contacts
Contact: Femme L Ambrosio, DDS 858 603-6345 femme.l.ambrosio@uth.tmc.edu
Contact: Arthur H Jeske, DDS, PhD 713 500 4506 arthur.h.jeske@uth.tmc.edu

Locations
United States, Texas
UT Pediatric Dentistry Clinic Houston Medical Center Recruiting
6655 Travis Suite 460, Texas, United States, 77030
Contact: Femme L Ambrosio, DDS     858-603-6345     femme.l.ambrosio@uth.tmc.edu    
Contact: Arthur H Jeske, DDS PhD     7135004506     arthur.h.jeske@uth.tmc.edu    
Sub-Investigator: Robert Tate, DDS MS            
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Femme L Ambrosio, DDS UT Health Science Center Houston
Study Chair: Arthur H Jeske, DDS, PhD UT Health Science Center Houston
  More Information

No publications provided

Responsible Party: Femme Ambrosio, University of Texas Health Science Center Houston
ClinicalTrials.gov Identifier: NCT00846690     History of Changes
Other Study ID Numbers: HSC-DB-08-0484
Study First Received: February 18, 2009
Last Updated: February 18, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
topical anesthetics
topical anesthesia
20% benzocaine
 TAC alternate gel
combination topical anesthetics
dental anesthesia

Additional relevant MeSH terms:
Pain, Postoperative
Toothache
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Benzocaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 26, 2012