N/A
N=109
Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus
Acute Otitis Media · Chronic Otitis Media · Recurrent Acute Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT00941993 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment — 89.9 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Iontophoresis System (Acclarent) (Device)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Integra LifeSciences Corporation
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment |
89.9 | — |
| PRIMARY Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects). |
1; 1 | — |
| SECONDARY Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale |
0.7 | — |
| SECONDARY Subject/Parent Reported Satisfaction With the In-office Procedure |
94.3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00941993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.