Early Phase 1 N=90 Health Services Research

Prevalence of Lidocaine Ineffectiveness in Adults With and Without ADHD

ADHD · PMS

Bottom Line

View on ClinicalTrials.gov: NCT03676725 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcome: Primary: Number of Subjects With Lidocaine Ineffectiveness — 11; 9; 16; 5 Participants — p=0.017

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Lidocaine gel (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: PhenoSolve, LLC
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Lidocaine Ineffectiveness	11; 9; 16; 5; 15; 3	0.017 sig

Summary

This work will assess the prevalence in the general population of the ineffectiveness of the anesthetic Lidocaine compared to males with ADHD and females with ADHD with or without PMS.

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria for both arms:

(1) known adverse reactions to lidocaine; (2) ADHD, ADD, and other inattention disorders; (3) epilepsy, IQ <80, severe head trauma, birth weight <2270 grams, and severe autism; (4) treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers; (5) generalized anxiety disorders (but dental-specific anxiety will not be an exclusion because many of these individuals may be ones with anxiety because of painful dental experiences with lidocaine ineffectiveness); (6) mouth sores; (7) Ehlers Danlos syndrome, (8) red hair, and (9) current pregnancy.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03676725). 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.