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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT00941993
First received: July 14, 2009
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Acute Otitis Media
Chronic Otitis Media
Recurrent Acute Otitis Media
Device: Iontophoresis System (Acclarent)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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)

Resource links provided by NLM:


Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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). [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

    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.



Enrollment: 109
Study Start Date: April 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: local anesthesia
tympanic membrane local anesthesia delivery system
Device: Iontophoresis System (Acclarent)
Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.
Other Name: Acclarent

  Eligibility

Ages Eligible for Study:   12 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941993

Locations
United States, South Carolina
Spartanburg ENT
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Henry "Fritz" Butehorn, III, MD Spartanburg ENT
  More Information

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT00941993     History of Changes
Other Study ID Numbers: CPR005000
Study First Received: July 14, 2009
Results First Received: July 2, 2014
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Anesthetics
Epinephrine
Epinephryl borate
Lidocaine
Racepinephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents

ClinicalTrials.gov processed this record on October 23, 2014