Overview
Validating a New Non-invasive Approach to Testing Lidocaine Effectiveness
Status:
Completed
Completed
Trial end date:
2020-03-30
2020-03-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
This work will assess the reliability of a simple painless test for the effectiveness of the commonly used local anesthetic lidocainePhase:
Early Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
PhenoSolve, LLCCollaborator:
Jacobi Medical CenterTreatments:
Lidocaine
Criteria
Arm 1 EligibilityInclusion 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