Coastal Ear, Nose and Throat’s Dr. Mary Mitskavich Co-Authors Study Revealing 90% Success for Tympanostomy Tube Replacement in Awake, Unrestrained Pediatric Patients

02/02/2016

NEPTUNE, NEW JERSEY – Tolerable and reliable local anesthetic, coupled with breakthrough ear tube delivery system, could make office-based pediatric tube replacement procedures possible. This procedure will be able to help young children avoid general anesthesia and surgery in an operating room setting. Two complementary technologies have been developed to mitigate past difficulties with in-office pediatric tube replacement. The first technology is an advanced iontophoresis system (IPS). The IPS system provides local anesthesia of the tympanic membrane (TM). The second is an automated myringotomy and tube delivery system (TDS) that permits rapid mechanical placement of the tube. Researcher and Otolaryngologist, Dr. Mary Mitskavich, in work performed jointly with researchers from South Florida Pediatric Otolaryngology, South Coast Ear, Nose and Throat, Ear Medical Group, Specialty Physician Associates, Acclarent Clinical Research, Central California Clinical Research, Advanced ENT and Allergy, University Ear, Nose and Throat and Witham Health Services, identified these findings in the recently published study in the International Journal of Pediatric Otolaryngology.

“Given how common this pediatric ambulatory surgical procedure is in the United States, I wanted to help identify a way to perform this procedure without the inherent risks associated with general anesthesia,” says Dr. Mitskavich, co-author of the study. "In other words, we wanted to evaluate the safety and efficacy of in-office pediatric tube placement using the TDS, with local anesthesia provided by the IPS, to be able to eventually offer this alternative to my pediatric patients.”
A total of 70 patients from 9 otolaryngology sites across the country participated in the study. The participant base was comprised of 36 females and 34 males, with a mean age of 7. Participants were evaluated for behavioral appropriateness and receptivity to the allotted levels of anesthetic utilized. Overall success of the procedure was identified at 90%. Other 2-week post-operative survey results revealed high levels of satisfaction, including:
• Overall satisfaction of 96.9%
• Willingness to recommend the procedure to others of 95.4%
• Tolerability of the tube placement procedure of 86.2%

What this means is that for appropriately selected patients, the combination of IPS and TDS technologies will permit safe, reliable, and tolerable in-office delivery of tubes in awake, unrestrained pediatric patients. “Operating-room based tube replacement for pediatric patients will no longer be the only option,” says Dr. Mitskavich. “We hope to offer many patients the opportunity to avoid pre-procedural fasting, separation anxiety, and post-procedural side-effects of general anesthesia, often associated with surgery in a hospital setting.”
Dr. Mitskavich is board certified in pediatric and adult Otolaryngology, and practices at Coastal Ear, Nose and Throat in Neptune, New Jersey (www.coastalearnoseandthroat.com)

About Coastal Ear, Nose and Throat
Coastal Ear, Nose and Throat, located in Neptune, New Jersey is committed to providing the highest quality, state-of-the-art medical care, and an exceptional patient experience. Coastal’s award winning, fellowship trained and board certified physicians treat basic and complex ear, nose and throat disorders in both children and adults. Patients receive comprehensive care from highly trained Otolaryngology sub-specialists close to home, making distant travel to New York City and Philadelphia unnecessary. The surgical sub-specialties at Coastal Ear, Nose and Throat include: including Rhinology, Head and Neck Cancer, Pediatric ENT, Laryngology/Voice and Neurotology.