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

Study Overview
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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.

Official Title
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First in Man Evaluation of the Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to the External Auditory Apparatus (FIM Iontophoresis Study)

Conditions
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Acute Otitis Media, Chronic Otitis Media, Recurrent Acute Otitis Media

Intervention / Treatment
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* Device: Iontophoresis System (Acclarent)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 12 months and older Both male and female patients eligible 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: 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 Markedly atrophic, retracted, atelectatic or perforated tympanic membrane Otitis externa Electrically sensitive patients and patients with electrically sensitive support systems (pacemakers, defibrillators, etc.) Damaged or denuded skin in the auditory canal Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane

Ages Eligible for Study
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Minimum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: local anesthesia<br>tympanic membrane local anesthesia delivery system | Device: Iontophoresis System (Acclarent)<br>* Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.<br>* Other names: Acclarent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment | Investigator performed a gentle tap of the tympanic membrane to assess whether adequate anesthesia was achieved following local anesthesia by iontophoresis. All subjects for which an ear procedure was attempted were considered to have achieved anesthesia effectiveness. | Day 0 | 
| Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects). |  | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale | Includes all subjects for whom Iontophoresis current delivery was initiated. The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. The Wong-Baker scores are reported by subject. | Day 0 | 
| Subject/Parent Reported Satisfaction With the In-office Procedure | Adult subjects or parents of pediatric subjects were asked to rate their agreement or disagreement with the statement: 'Overall, I am satisfied with the whole procedure'. Response options included: 'Strongly Disagree', 'Disagree', 'Neutral', 'Agree' or 'Strongly Agree'. The number of respondents who reported that they 'agree' or 'strongly agree' that they were satisfied with the whole procedure are reported. The analysis population does not include the full study cohort as this survey question was implemented during, not prior to, the enrollment period. | Day 0 |