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

First in Man Evaluation of the Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to the External Auditory Apparatus (FIM Iontophoresis Study)

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Acute Otitis Media; Acute Otitis Media; Chronic Otitis Media
• Intervention / Treatment: Device: Iontophoresis System (Acclarent)

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg ENT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: local anesthesia; tympanic membrane local anesthesia delivery system	Device: Iontophoresis System (Acclarent); Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.; Other Names: Acclarent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale	Includes all subjects for whom Iontophoresis current delivery was initiated. The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. The Wong-Baker scores are reported by subject.	Day 0
Subject/Parent Reported Satisfaction With the In-office Procedure	Adult subjects or parents of pediatric subjects were asked to rate their agreement or disagreement with the statement: 'Overall, I am satisfied with the whole procedure'. Response options included: 'Strongly Disagree', 'Disagree', 'Neutral', 'Agree' or 'Strongly Agree'. The number of respondents who reported that they 'agree' or 'strongly agree' that they were satisfied with the whole procedure are reported. The analysis population does not include the full study cohort as this survey question was implemented during, not prior to, the enrollment period.	Day 0

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale.	The Wong-Baker FACES pain scoring system is a subject-reported instrument using a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Pain scores were recorded for all subjects for which an ear procedure was attempted.Pain scores are presented by subject, as an average of pain scores for both ears.	Day 0

Collaborators and Investigators

• Sponsor: Acclarent
• Investigators: Principal Investigator: Henry "Fritz" Butehorn, III, MD, Spartanburg ENT

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: July 14, 2009
• First Submitted That Met QC Criteria: July 17, 2009
• First Posted (Estimate): July 20, 2009

Study Record Updates

• Last Update Posted (Estimate): August 4, 2014
• Last Update Submitted That Met QC Criteria: July 2, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: CPR005000