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

Acute Otitis Media Clinical Trial

— IONTO  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941993
• Other study ID #: CPR005000
• Status: Completed
• Phase: N/A
• First received: July 14, 2009
• Last updated: July 2, 2014
• Start date: April 2008
• Est. completion date: January 2011

Study information

• Verified date: July 2014
• Source: Acclarent
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Otitis Media
• Chronic Otitis Media
• Otitis
• Otitis Media
• Recurrent Acute Otitis Media

Intervention

Device:
• Iontophoresis System (Acclarent)
Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.

Locations

Country	Name	City	State
United States	Spartanburg ENT	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Acclarent

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Primary	Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects).		Day 0	Yes
Secondary	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	No
Secondary	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	No