Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus (IONTO)

Integra LifeSciences

Status: Completed

Conditions: Acute Otitis Media; Chronic Otitis Media; Recurrent Acute Otitis Media

Treatments: Device: Iontophoresis System (Acclarent)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00941993

CPR005000

Details and patient eligibility

About

This is a non-randomized, multicenter, prospective, clinical study intended to evaluate the effectiveness of a method for iontophoretic delivery of a buffered lidocaine/epinephrine solution for provision of tympanic membrane anesthesia in patients who are indicated for an ear procedure requiring penetration of the tympanic membrane, including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube placement.

Enrollment: 109 patients

Sex: All

Ages: 12+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 12 months and older
2. Both male and female patients eligible
3. Patients are indicated for procedures requiring penetration of the tympanic membrane (including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube implant)

Exclusion criteria

1. Patients with a history of sensitivity or reaction to lidocaine, epinephrine or any hypersensitivity to local anesthetics of the amide type or any component of the drug solution
2. Markedly atrophic, retracted, atelectatic or perforated tympanic membrane
3. Otitis externa
4. Electrically sensitive patients and patients with electrically sensitive support systems (pacemakers, defibrillators, etc.)
5. Damaged or denuded skin in the auditory canal
6. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 1 patient group

local anesthesia

Experimental group

Description:

tympanic membrane local anesthesia delivery system

Treatment:

Device: Iontophoresis System (Acclarent)