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

NCT00941993 | Completed Results

• 1 other identifier: CPR005000
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Otitis Media; Chronic Otitis Media; Recurrent Acute Otitis Media

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Other Outcomes (1)

• Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale.

  Day 0

Study Arms (1)

local anesthesia

EXPERIMENTAL

tympanic membrane local anesthesia delivery system

Device: Iontophoresis System (Acclarent)

Interventions

Iontophoresis System (Acclarent) DEVICE

Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.

Also known as: Acclarent

local anesthesia

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Acclarent: collaborator

Study Sites (1)

Spartanburg ENT

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Clinical Director
• Organization: Acclarent

lenglan1@its.jnj.com

650-687-5888

Study Officials

• Henry "Fritz" Butehorn, III, MD

  Spartanburg ENT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 20, 2009
• Study Start: April 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 12, 2024
• Results First Posted: August 4, 2014

Record last verified: 2024-07

Locations

US (1)