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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Otitis Media Chronic Otitis Media Recurrent Acute Otitis Media

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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local anesthesia

tympanic membrane local anesthesia delivery system

Group Type EXPERIMENTAL

Iontophoresis System (Acclarent)

Intervention Type DEVICE

Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.

Interventions

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Iontophoresis System (Acclarent)

Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.

Intervention Type DEVICE

Other Intervention Names

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Acclarent

Eligibility Criteria

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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

Minimum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No