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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00353041
• Other study ID #: UToronto
• Status: Recruiting
• Phase: N/A
• First received: July 13, 2006
• Last updated: July 13, 2006
• Start date: July 2006
• Est. completion date: December 2006

Study information

• Verified date: July 2006
• Source: University of Toronto
• Contact: Jasdev Bhalla, BDS
• Phone: 4169794922
• Email: drjasdev[@]yahoo.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. In good health (ASA 1 or ASA 2)

2. Weight between 40-100kg, inclusive.

3. Between ages 18-70, inclusive.

4. Informed consent

Exclusion Criteria:

1. ASA 3 or higher.

2. History of allergy to sulfites, lidocaine or mepivacaine.

3. Taking any analgesic 48hrs before testing, such as an NSAID, opioid, or acetaminophen.

4. Pregnancy.

5. Recent oral trauma.

6. Lack of informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• lidocaine topical

Locations

Country	Name	City	State
Canada	Faculty of Dentistry	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain
Secondary	Heart rate