NCT00353041

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jul 2006

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 17, 2006

Status Verified

July 1, 2006

First QC Date

July 13, 2006

Last Update Submit

July 13, 2006

Conditions

Pain

Keywords

topicalanestheticpain

Outcome Measures

Primary Outcomes (1)

  • pain

Secondary Outcomes (1)

  • Heart rate

Interventions

lidocaine topicalDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Toronto, Ontario, M5G 1G6, Canada

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Daniel A Haas, DDS, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasdev Bhalla, BDS

CONTACT

4169794922drjasdev@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
ECT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2006

First Posted

July 17, 2006

Study Start

July 1, 2006

Study Completion

December 1, 2006

Last Updated

July 17, 2006

Record last verified: 2006-07

Locations

CA(1)