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N/A N=47 Randomized Treatment

Kinetic Anesthesia Device Study

Local Anaesthetic Complication · Pain

Bottom Line

View on ClinicalTrials.gov: NCT03344510 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Pain of Lidocaine Injection, Measured by Visual Analog Scale. — 7.5; 26 mm on visual analog scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Kinetic Anesthesia Device (Device); Control (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Pennsylvania
Primary completion
Jan 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Pain of Lidocaine Injection, Measured by Visual Analog Scale.		 7.5; 26 —
SECONDARY
Patient Preference for Injection With or Without Kinetic Anesthesia Device		 33; 6 —

Summary

Patients experience discomfort from lidocaine injections. Vibrating kinetic anesthesia devices (KAD) have been shown to reduce pain of injections in dentistry, pediatrics, and dermatology, though no studies of lidocaine injections in sites common to dermatologic surgery exist. We will conduct a randomized split-body study, in which healthy volunteers will rate the pain of lidocaine injections on a visual analog scale, with and without the vibrating kinetic anesthesia device being used during injection

Eligibility Criteria

Inclusion Criteria

  • Adult volunteers greater than or equal to 18 years of age
  • Able and willing to provide informed consent
  • Able to comprehend and comply with study instructions, and able to complete necessary evaluations.

Exclusion Criteria

  • Patients unable or unwilling to provide informed consent.
  • Patients with lidocaine allergy
  • Patients with known pain-related or neurological condition.
  • Patients with a known cardiac condition
  • Vulnerable populations
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03344510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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