Topical Anaesthesia Clinical Trial
Official title:
A Study of the Use of Microneedle Patches to Deliver Topical Lidocaine in the Oral Cavity
To look at the effect on patient perceived pain resulting from infiltration injection with local anaesthetic in a dental syringe with prior application of topical anaesthetic to the oral mucosa on a microneedle patch compared to a patch with no microneedles. To look at the safety of the patches when applied to the oral mucosa.
This is a randomised, 2 treatment, double blind design, with respect to the clinical assessor
and subject, split mouth, crossover design with a negative control (patch with no
microneedles).
Potential participants will be invited to attend a screening visit. At this visit
participants will be asked to read and sign a Participant Information Sheet and Consent Form
prior to any study procedures being performed. They will be given ample time to decide if
they wish to participate in the study.
A dentally qualified clinician will record the participant's demographics, medical history,
current/concomitant medications, perform an oral soft tissue examination and ensure the
participant fulfils the inclusion and exclusion criteria for the study. Two areas of the
mouth will be identified for assessment during the study. The areas of the mouth will be
identified as S1 or S2. Site S1 will be left or right palatal mucosa adjacent to the premolar
area and S2 will be left or right upper buccal mucosa adjacent to the upper lateral incisor
area.
Participants who successfully fulfil all the necessary entrance criteria will be provided
with training by study staff on how to use a VAS record sheet and randomised on to the study
to receive treatment combination A or B at in a random order according to a predetermined
randomisation schedule supplied by the study statistician. The screening visit and first
treatment visit will occur at the same visit. The treatment possibilities are outlined below:
Treatment A The application of a 5% topical lidocaine gel to one of the identified areas
within the participants mouth using a microneedle patch. The microneedle patch will be
applied to the oral mucosa of the identified site for 3 minutes, followed by infiltration
with local anaesthetic to one of the identified areas within the participants mouth.
Treatment B The application of a 5% topical lidocaine gel to one of the identified sites
within the participants mouth using a patch with no microneedles. The patch with no
microneedles will be applied to the oral mucosa of the identified site for 3 minutes,
followed by infiltration with local anaesthetic to one of the identified areas within the
participants mouth.
The chosen sites will be: S1; left and right palatal mucosa adjacent to the premolar area or
S2; left and right upper buccal mucosa adjacent to the upper lateral incisor area. Each
participant at the first visit will have either S1 or S2 sites allocated for treatment. For
example, Treatment A will be allocated to S1 left side and Treatment B to S1 right side or
vice versa. At the second visit, 2 weeks (+/- 3 days) after the first visit, Treatment B will
be allocated to S2 left side and Treatment A to S2 right side. Both sides of the mouth for S1
or S2 will be treated at the same. After each treatment participants will be asked to make
pain assessments relating to needle insertion into the oral mucosa and the giving of the
local infiltration anaesthetic.
It is envisaged that a sufficient number of potential participants will be screened in order
to randomise 16 onto the study.
Assessment methods: Pain assessments will be performed after application of the topical
anaesthetic for 3 minutes. Each test will be performed sequentially i.e. 3 separate needle
insertions, with pain assessments recorded by the participant using a Visual Analogue Scale
(VAS) and a verbal pain grading after each test. The level of pain at S1 or S2 will be
assessed as follows:
Test I. A short dental needle, mounted on a dental syringe containing a cartridge of 2%
lidocaine hydrochloride and 1:80,000 adrenaline, will be used to penetrate the oral mucosa at
the treated site and the patient asked to score the pain using a VAS rating scale and by
verbal grading of zero, mild, moderate or severe.
Test 2. The same needle will be inserted through the oral mucosa and down to contact bone.
Pain will be assessed as in Test 1.
Test 3. The same needle will be again inserted through the oral mucosa and the cartridge of
local anaesthetic will be injected into the site. Pain will be again assessed as in Test I.
Following enrolment on to the study, participants will be given written and verbal
instructions on the VAS and how to complete it.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT02460627 -
Topical Lidocaine After Arthroscopy on Knee
|
Phase 1 |