Overview

Validating a New Non-invasive Approach to Testing Lidocaine Effectiveness

Status:
Completed
Trial end date:
2020-03-30
Target enrollment:
0
Participant gender:
All
Summary
This work will assess the reliability of a simple painless test for the effectiveness of the commonly used local anesthetic lidocaine
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
PhenoSolve, LLC
Collaborator:
Jacobi Medical Center
Treatments:
Lidocaine
Criteria
Arm 1 Eligibility

Inclusion Criteria:

- Report "get numb at dentist"

Exclusion Criteria:

- ADHD, ADD, and other inattention disorders

- Known adverse reactions to lidocaine;

- Epilepsy

- IQ <80

- Severe head trauma

- Birth weight <2270 grams

- Severe autism

- 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)

- Mouth sores

- Ehlers Danlos syndrome

- Red hair

- Current pregnancy

- Treatment currently with potassium or potassium-elevating drugs such as
renin-angiotensin-aldosterone blockers

Angiotensin Converting Enzyme Inhibitors

- Alacepril (not available in US)

- Benazepril (Lotensin)

- Captopril (trade name Capoten)

- Cilazapril (Inhibace)

- Delapril (not available in US)

- Enalapril (Vasotec/Renitec)

- Fosinopril (Fositen/Monopril)

- Imidapril (Tanatril)

- Lisinopril (Listril/Lopril/Novatec/Prinivil/Zestril)

- Moexipril (Univasc)

- Perindopril (Coversyl/Aceon/Perindo)

- Quinapril (Accupril)

- Ramipril (Altace/Prilace/Ramace/Ramiwin/Triatec/Tritace)

- Spirapril (Renormax)

- Temocapril (not available in US)

- Teprotide (but not active by oral administration and not used in US)

- Trandolapril (Mavik/Odrik/Gopten)

- Zofenopril

Angiotensin receptor blockers

- Azilsartan (Edarbi)

- Candesartan (Atacand)

- Eprosartan (Teveten)

- Fimasartan (Kanarb)

- Irbesartan (Avapro)

- Losartan (Cozaar)

- Olmesartan (Benicar/Olmetec)

- Telmisartan (Micardis)

- Valsartan (Diovan)

Aldosterone antagonists

- Spironolactone (Aldactone)

- Eplerenone (Inspra)

Renin inhibitors - Aliskiren (Tekturna, Rasilez)

Other potassium elevating agents

- Antibiotics, including penicillin G and trimethoprim

- Azole antifungals

- Beta-blockers

- Herbal supplements, including milkweed, lily of the valley, Siberian ginseng, Hawthorn
berries

- Heparin

- Nonsteroidal anti-inflammatory medications (NSAIDs)

- Oral contraceptives containing drospirenone

Arm 2 Eligibility

Inclusion Criteria:

- Report "trouble getting numb at dentist"

Exclusion Criteria:

- Known adverse reactions to lidocaine;

- Epilepsy

- IQ <80

- Severe head trauma

- Birth weight <2270 grams

- Severe autism

- 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)

- Mouth sores

- Ehlers Danlos syndrome

- Red hair

- Current pregnancy

- Treatment currently with potassium or potassium-elevating drugs such as
renin-angiotensin-aldosterone blockers

Angiotensin Converting Enzyme Inhibitors

- Alacepril (not available in US)

- Benazepril (Lotensin)

- Captopril (trade name Capoten)

- Cilazapril (Inhibace)

- Delapril (not available in US)

- Enalapril (Vasotec/Renitec)

- Fosinopril (Fositen/Monopril)

- Imidapril (Tanatril)

- Lisinopril (Listril/Lopril/Novatec/Prinivil/Zestril)

- Moexipril (Univasc)

- Perindopril (Coversyl/Aceon/Perindo)

- Quinapril (Accupril)

- Ramipril (Altace/Prilace/Ramace/Ramiwin/Triatec/Tritace)

- Spirapril (Renormax)

- Temocapril (not available in US)

- Teprotide (but not active by oral administration and not used in US)

- Trandolapril (Mavik/Odrik/Gopten)

- Zofenopril

Angiotensin receptor blockers

- Azilsartan (Edarbi)

- Candesartan (Atacand)

- Eprosartan (Teveten)

- Fimasartan (Kanarb)

- Irbesartan (Avapro)

- Losartan (Cozaar)

- Olmesartan (Benicar/Olmetec)

- Telmisartan (Micardis)

- Valsartan (Diovan)

Aldosterone antagonists

- Spironolactone (Aldactone)

- Eplerenone (Inspra)

Renin inhibitors

- Aliskiren (Tekturna, Rasilez)

Other potassium elevating agents

- Antibiotics, including penicillin G and trimethoprim

- Azole antifungals

- Beta-blockers

- Herbal supplements, including milkweed, lily of the valley, Siberian ginseng, Hawthorn
berries

- Heparin

- Nonsteroidal anti-inflammatory medications (NSAIDs)

- Oral contraceptives containing drospirenone