First in Man Evaluation of the Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to the External Auditory Apparatus (FIM Iontophoresis Study)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Acute Otitis Media
- Sponsor
- Integra LifeSciences Corporation
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment
Time Frame: Day 0
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.
Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects).
Time Frame: Day 0
Secondary Outcomes
- Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale(Day 0)
- Subject/Parent Reported Satisfaction With the In-office Procedure(Day 0)