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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
109
Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.
Spartanburg ENT
Spartanburg, South Carolina, United States
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
Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects).
Time frame: Day 0
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
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
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