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

University of Toronto

Status: Unknown

Conditions: Pain

Treatments: Drug: lidocaine topical

Study type: Interventional

Funder types: Other

Identifiers

NCT00353041

UToronto

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Educational/Counseling/Training

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind