Acute Otitis Media, Chronic Otitis Media, Recurrent Acute Otitis Media
Conditions
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.
Interventions
DEVICEIontophoresis System (Acclarent)
Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.
Sponsors
Acclarent
Integra LifeSciences Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment | Day 0 | 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. |
| Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects). | Day 0 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale | Day 0 | 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. |
| Subject/Parent Reported Satisfaction With the In-office Procedure | Day 0 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale. | Day 0 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Iontophoretic Delivery of Anesthesia Tympanic membrane anesthesia delivery system
Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine. | 109 |
| Total | 109 |
Baseline characteristics
| Characteristic | Iontophoretic Delivery of Anesthesia |
|---|---|
| Age, Continuous | 18.0 years STANDARD_DEVIATION 22 |
| Region of Enrollment United States | 109 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 109 |
| serious Total, serious adverse events | 0 / 109 |
Outcome results
Primary
Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects).
Time frame: Day 0
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anesthesia | Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects). | Vertigo | 1 participants |
| Anesthesia | Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects). | Mild erythema at return electrode | 1 participants |
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.
Time frame: Day 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anesthesia | Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment | 89.9 percentage of subjects |
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.
Time frame: Day 0
Population: Analysis population includes subjects completing iontophoresis for which Wong Baker scores are available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anesthesia | Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale | 0.7 units on a scale | Standard Deviation 1.2 |
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.
Time frame: Day 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anesthesia | Subject/Parent Reported Satisfaction With the In-office Procedure | 94.3 % adult subjects or parents |
Other Pre-specified
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.
Time frame: Day 0
Population: Analysis population includes subjects who completed anesthesia and for which an ear procedure was attempted
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anesthesia | Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale. | 1.0 units on a scale | Standard Deviation 1.5 |