Trial Outcomes & Findings for Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus (NCT NCT00941993)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

109 participants

Primary outcome timeframe

Day 0

Results posted on

2024-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Iontophoretic Delivery of Local 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.
Overall Study STARTED	109
Overall Study COMPLETED	109
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Iontophoretic Delivery of Anesthesia n=109 Participants 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.
Age, Continuous	18.0 years STANDARD_DEVIATION 22.0 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants
Region of Enrollment United States	109 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anesthesia n=109 Participants 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.
Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment	89.9 percentage of subjects Interval 82.7 to 94.9

PRIMARY outcome

Timeframe: Day 0

Outcome measures

Outcome measures
Measure	Anesthesia n=109 Participants 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.
Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects). Vertigo	1 participants
Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects). Mild erythema at return electrode	1 participants

SECONDARY outcome

Timeframe: Day 0

Population: Analysis population includes subjects completing iontophoresis for which Wong Baker scores are available.

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.

Outcome measures

Outcome measures
Measure	Anesthesia n=101 Participants 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.
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anesthesia n=87 Participants 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.
Subject/Parent Reported Satisfaction With the In-office Procedure	94.3 % adult subjects or parents Interval 87.1 to 98.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Population: Analysis population includes subjects who completed anesthesia and for which an ear procedure was attempted

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.

Outcome measures

Outcome measures
Measure	Anesthesia n=99 Participants 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.
Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale.	1.0 units on a scale Standard Deviation 1.5

Adverse Events

Anesthesia

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Anesthesia n=109 participants at risk 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.
Nervous system disorders Vertigo	0.92% 1/109 • Number of events 1 • 1 day (day of procedure)
Skin and subcutaneous tissue disorders Mild Erythema at return electrode	0.92% 1/109 • Number of events 1 • 1 day (day of procedure)

Additional Information

Clinical Director

Acclarent

Phone: 650-687-5888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60