PainNCT00353041
A Study of the Effect of Time on Topical Anesthetic Efficacy.
A study testing lidocaine topical in people with Pain, run by University of Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- lidocaine topical
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2006to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In good health (ASA 1 or ASA 2)
- Weight between 40-100kg, inclusive.
- Between ages 18-70, inclusive.
- Informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Toronto, Ontario, M5G 1G6
Jasdev Bhalla, BDS, 416-979-4922 ext. 4325, drjasdev@yahoo.com
Jasdev Bhalla, BDS
About this study
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.
Read the 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.
- Conditions
- Pain
- Being tested
- lidocaine topical
- Keywords
- topical, anesthetic, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine topicalDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Secondary outcomes (1)
Heart rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startJul 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Daniel A Haas, DDS, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353041
- Sponsor's protocol ID
- UToronto
- Status last verified
- Jul 2006
- First submitted
- 13 Jul 2006
- Last updated
- 17 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of Time on Topical Anesthetic Efficacy.
- ClinicalTrials.gov ID
- NCT00353041
- Acronym / sponsor ID
- UToronto
- Conditions
- Pain
- Keywords
- topical, anesthetic, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Dec 2006
- First posted
- 17 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In good health (ASA 1 or ASA 2)
- Weight between 40-100kg, inclusive.
- Between ages 18-70, inclusive.
- Informed consent
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine topical | Drug | – |
Primary outcome
pain
1 secondary outcome
Heart rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel A Haas, DDS, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lidocaine topical in people with Pain, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jasdev Bhalla, BDS (4169794922 ext. 4325, drjasdev@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2006.