A Study of the Effect of Time on Topical Anesthetic Efficacy.

This study is currently recruiting participants.

Verified by University of Toronto, July 2006

First Received: July 13, 2006 No Changes Posted

Sponsored by:	University of Toronto
Information provided by:	University of Toronto
ClinicalTrials.gov Identifier:	NCT00353041

Purpose

This is a study of the effect of time on the effectiveness of topical anesthetics in the mouth. The Null Hypothesis is: Regardless of the time of application over a 10-minute period, there is no difference in the clinical effectiveness of the topical anesthetic 5% lidocaine on (a) the pain of needle stick insertion and (b) the pain of local anaesthetic administration.

Condition	Intervention
Pain	Drug: lidocaine topical

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A Study of the Effect of Time on Topical Anesthetic Efficacy.

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

Drug Information available for: Lidocaine

U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:

pain

Secondary Outcome Measures:

Heart rate

Estimated Enrollment:	90
Study Start Date:	July 2006
Estimated Study Completion Date:	December 2006

Detailed Description:

The study design will be a double blind randomized controlled split-mouth clinical trial. It is proposed to compare the effectiveness of the standard topical anesthetic 5% lidocaine with a placebo over the time period of 2, 5 and 10 minutes after application. The topical will be placed on the palatal soft tissue where the perception of pain is the highest in the oral cavity. Both the pain of needle insertion and the pain of local anesthetic injection will be compared.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

In good health (ASA 1 or ASA 2)
Weight between 40-100kg, inclusive.
Between ages 18-70, inclusive.
Informed consent

Exclusion Criteria:

ASA 3 or higher.
History of allergy to sulfites, lidocaine or mepivacaine.
Taking any analgesic 48hrs before testing, such as an NSAID, opioid, or acetaminophen.
Pregnancy.
Recent oral trauma.
Lack of informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353041

Contacts

Contact: Jasdev Bhalla, BDS

4169794922 ext 4325

drjasdev@yahoo.com

Locations

Canada, Ontario
Faculty of Dentistry	Recruiting
Toronto, Ontario, Canada, M5G 1G6
Contact: Jasdev Bhalla, BDS 416-979-4922 ext 4325 drjasdev@yahoo.com
Principal Investigator: Jasdev Bhalla, BDS

Sponsors and Collaborators

University of Toronto

Investigators

Principal Investigator:

Daniel A Haas, DDS, PhD

University of Toronto

More Information

No publications provided

Study ID Numbers:	UToronto
Study First Received:	July 13, 2006
Last Updated:	July 13, 2006
ClinicalTrials.gov Identifier:	NCT00353041 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Toronto:

topical
anesthetic
pain

Study placed in the following topic categories:

Lidocaine
Central Nervous System Depressants
Anesthetics
Pain

Additional relevant MeSH terms:

Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 03, 2009