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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

February 18, 2009
February 18, 2009
January 2009
March 2009   (final data collection date for primary outcome measure)
visual analogue scale score [ Time Frame: pre-op, insertion, every minute post-op for 10 minutes ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel
Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel for Control of Pain of Dental Needle Insertion in the Palate

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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Dental Pain
  • Postoperative Pain
  • Drug: benzocaine
    20% benzocaine., topical placement onto site, minimal amount, for 1 minute
    Other Name: Hurricaine
  • Drug: TAC alternate gel
    use 1 pump, place topically onto site, leave for 1-3 minutes
    Other Name: 20% TAC alternate gel
  • Active Comparator: Benzocaine
    serves as "active" control
    Intervention: Drug: benzocaine
  • Experimental: TAC
    serves as comparator
    Intervention: Drug: TAC alternate gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
May 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
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
United States
 
NCT00846690
HSC-DB-08-0484
No
Femme Ambrosio, University of Texas Health Science Center Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Femme L Ambrosio, DDS UT Health Science Center Houston
Study Chair: Arthur H Jeske, DDS, PhD UT Health Science Center Houston
The University of Texas Health Science Center, Houston
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP