Skip to main content
OpenTrials
Completed

NCT Number: NCT00941993

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Otitis Media Chronic Otitis Media Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases Recurrent Acute Otitis Media

Age range

12 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spartanburg ENT

Spartanburg, South Carolina, 29303, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 12 months and older
  • Both male and female patients eligible
  • 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

  • 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
  • Markedly atrophic, retracted, atelectatic or perforated tympanic membrane
  • Otitis externa
  • Electrically sensitive patients and patients with electrically sensitive support systems (pacemakers, defibrillators, etc.)
  • Damaged or denuded skin in the auditory canal
  • Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane

Treatment and study plan

Iontophoresis System (Acclarent)

Device

Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.

Other names: Acclarent

Primary outcomes

  1. Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment

    Time frame: 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.

  2. Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects).

    Time frame: Day 0

Secondary outcomes

  1. Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale

    Time frame: 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.

  2. Subject/Parent Reported Satisfaction With the In-office Procedure

    Time frame: 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 outcomes

  1. Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Acclarent

Registry information

Official study title

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

Acronym: IONTO

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 20, 2009
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.