Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

Postoperative Pain Clinical Trial

Official title:

Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel for Control of Pain of Dental Needle Insertion in the Palate

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00846690
• Other study ID #: HSC-DB-08-0484
• Status: Unknown status
• Phase: Phase 4
• First received: February 18, 2009
• Last updated: February 18, 2009
• Start date: January 2009
• Est. completion date: May 2009

Study information

• Verified date: February 2009
• Source: The University of Texas Health Science Center, Houston
• Contact: Femme L Ambrosio, DDS
• Phone: 858 603-6345
• Email: femme.l.ambrosio[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Pain
• Pain, Postoperative
• Postoperative Pain
• Toothache

Intervention

Drug:
• benzocaine
20% benzocaine., topical placement onto site, minimal amount, for 1 minute
• TAC alternate gel
use 1 pump, place topically onto site, leave for 1-3 minutes

Locations

Country	Name	City	State
United States	UT Pediatric Dentistry Clinic Houston Medical Center	6655 Travis Suite 460	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale score		pre-op, insertion, every minute post-op for 10 minutes
Secondary	blood pressure		three times pre-op, insertion, ten times post-op
Secondary	oxygen saturation		three times pre-op, insertion, ten times post-op
Secondary	heart rate		three times pre-op, insertion, ten times post-op