Lidocaine Administration Using STAR Particles

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-19

Study Completion Date

2023-06-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is being done to answer the question: Do STAR particles (tiny pieces of ceramic with small spikes) help numbing gel (a gel that helps you feel less pain) work more quickly to provide local anesthesia or numbing in a specific area? Research participants will provide feedback on how quickly the STAR particles with the numbing gel can provide anesthesia. Participants will report their sensation at either 10 or 20 minutes after application of the numbing gel.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Functional Microarray-Facilitated Lidocaine Liposomal Cream Absorption for Cutaneous Anesthesia in Volunteers

NCT00387296

Wounds

WITHDRAWN PHASE2

Prospective Evaluation of Topical Anesthesia in Children

NCT04378283

Skin Lacerations

COMPLETED NA

Needle-Free Lidocaine Injection vs Traditional Local Anesthesia in Infant Lumbar Puncture

NCT06552351

Anesthesia

NOT_YET_RECRUITING NA

Kinetic Anesthesia Device Study

NCT03344510

Local Anaesthetic Complication Pain

COMPLETED NA

Jet Injection of 1% Buffered Lidocaine Versus Topical EMLA for Local Anesthesia Before Lumbar Puncture in Children

NCT01628874

Lumbar Puncture Topical Analgesia

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study aims to find out if the combination of STAR particles with numbing gel can deliver anesthesia faster than applying the gel by itself. STAR particles are very small particles with microneedles on the surface that can increase and create small punctures in the skin. The small punctures should allow for the numbing gel to work more quickly and allow the area to become numb more quickly.

After pretreatment with STAR particles (applied to the right or left arm) and aloe gel (used as a control condition in the contralateral arm) a numbing gel will be applied. A Pin-Prick test will be performed to evaluate local anesthesia from the numbing gel; half the participants will be evaluated 10 minutes after application of the numbing gel and the other half will be assessed 20 minutes after the numbing gel is applied. The study team will also assess pain after needle insertion and measure how much water is being lost from the skin using a device called a Vapometer before and after the STAR particle and aloe gel applications. Participants will have follow-up calls 24 hours and 1 week after the visit to ask about any changes to the skin where the STAR particles were applied.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia, Local

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lidocaine-epinephrine-tetracaine (LET) Gel After and Without STAR Particle Application

Children, adolescents, and young adults will receive local anesthesia with lidocaine-epinephrine-tetracaine (LET) gel via different methods on different arms. One arm will have STAR particles used prior to LET gel and the other arm will have aloe gel applied prior to LET gel.

Group Type EXPERIMENTAL

LET Gel after STAR Particle Application (Right or Left Arm)

Intervention Type DEVICE

STAR particles are made of titanium dioxide, a widely used and safe ceramic material found in sunscreens, cosmetics, and paint. The particles vary in concentration and length in order to find the optimal concentration and length. Topical lidocaine (0.5 gm of Lidocaine in LET gel) will be applied immediately after applying a STAR particle preparation to the volar surface of the antecubital fossa.

LET Gel Application without STAR Particle Application (Contralateral Arm)

Intervention Type OTHER

Topical lidocaine (0.5 gm of Lidocaine in LET gel) will be applied immediately after applying aloe gel (control condition) to the volar surface of the antecubital fossa of the contralateral arm to the one receiving the STAR particle preparation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LET Gel after STAR Particle Application (Right or Left Arm)

STAR particles are made of titanium dioxide, a widely used and safe ceramic material found in sunscreens, cosmetics, and paint. The particles vary in concentration and length in order to find the optimal concentration and length. Topical lidocaine (0.5 gm of Lidocaine in LET gel) will be applied immediately after applying a STAR particle preparation to the volar surface of the antecubital fossa.

Intervention Type DEVICE

LET Gel Application without STAR Particle Application (Contralateral Arm)

Topical lidocaine (0.5 gm of Lidocaine in LET gel) will be applied immediately after applying aloe gel (control condition) to the volar surface of the antecubital fossa of the contralateral arm to the one receiving the STAR particle preparation.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

STAR Particle preparation Aloe Gel before LET Gel application Topical Lidocaine Control

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children, adolescents, and young adults, 10 to 21 years of age
* In good general health as determined by a medical history
* Willing to provide informed assent with parental consent and follow study requirements

Exclusion Criteria

* Is chronically using pain medication
* Has a plan to move to another location in the next 12 months or foresees any other reason that participation in the study would be disrupted during the next 12 months
* Has skin disorders or skin allergies
* Has any previous allergy or adverse reaction to STAR particle ingredients (Titanium Dioxide)
* Has abnormal (e.g., tattooed) skin at proposed the site(s) of STAR particle application
* Has known neurological conditions that might affect sensory function or perception of pain
* Has any condition (social or medical), which in the opinion of the investigator would make study participation unsafe, would interfere with adherence to the clinical study requirements, or would complicate data interpretation

Minimum Eligible Age

10 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes