Overview

This trial is active, not recruiting.

Conditions acute otitis media, chronic otitis media, recurrent acute otitis media
Treatment iontophoresis system (acclarent)
Sponsor Acclarent
Start date April 2008
End date May 2011
Trial size 200 participants
Trial identifier NCT00941993, CPR005000

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 local anesthetic procedures requiring penetration of the tympanic membrane, including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube placement.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
tympanic membrane anesthesia delivery system
iontophoresis system (acclarent) Acclarent
Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.

Primary Outcomes

Measure
Evaluate the anesthetic effect of the Acclarent designed iontophoresis local anesthesia system.
time frame: 12 hours

Secondary Outcomes

Measure
Evaluate patient tolerability of the bilateral iontophoresis procedure.
time frame: 12 hours
Evaluate parent satisfaction with the in-office procedure.
time frame: 12 hours
Evaluate any adverse effects associated with the iontophoresis system.
time frame: 12 hours

Eligibility Criteria

Male or female participants at least 12 months old.

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

Additional Information

Official title First in Man Evaluation of the Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to the External Auditory Apparatus (FIM Iontophoresis Study)
Principal investigator xx xx
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by Acclarent.