Pain
Conditions
Keywords
topical, anesthetic, pain
Brief 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.
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.
Interventions
Sponsors
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
ECT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate | — |
Countries
Canada
Contacts
Primary ContactJasdev Bhalla, BDS
Outcome results
None listed