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Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus - NCT00941993-30309(Clinical Trial 302665)



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City:  Atlanta
State:  
GA
Zip Code: 30309
Conditions: Acute Otitis Media - Chronic Otitis Media - Recurrent Acute Otitis Media
Purpose: This is a non-randomized, multi-center, 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 local anesthetic procedures requiring penetration of the tympanic membrane, including, but not limited to, myringtomy, tympanocentesis with culture or tympanostomy with tube placement.
Study summary: The effectiveness of the anesthetic method will be assessed by the investigator after completion of iontophoresis delivery and within 5 minutes of removing the system. Patients will also be asked to rate the effectiveness of the anesthetic method after the completion of the indicated ear procedure (before any suction is performed), using a pain scale such as the Wong-Baker Faces Pain Scale.
Criteria: 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
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2011
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