Ear Tube Placement in Kids WITHOUT Sedation (Starting at 12 Months of Age)

A recent report describes how using a relatively old technology, ear tube placement can now be performed in children starting at 12 months of age with chronic ear infections or hearing loss due to fluid buildup without the need for sedation of any kind nor aggressive restraints (ie papoose). Historically, ear tube placement in the office without sedation is typically performed starting at around 12 years of age using standard local anesthesia techniques. Any younger, a child could not be trusted to stay still during the procedure due to presence of some discomfort.

In any case, a Texan ear group reports how they accomplished this simple procedure at such young ages.

First, the ear canal is cleaned as much as possible of all earwax and debris. The ear canal is than filled with an anesthetic liquid (concoction of lidocaine, epinephrine, and sodium bicarbonate). Over 10 minutes, iontophoresis was than used to induce profound local anesthesia to the ear canal and eardrum. The liquid was than suctioned out and ear tube placement was performed with a reported 90% success rate (78 of 86 ears; 17 subjects were 3 years old or younger; 8 were 12 months old).

The key to success required 3 "new" elements.

• Iontophoresis device made by Acclarent. There are other iontophoresis devices in the market (Medtronic and Otomed), but none adapted for simultaneous bilateral ear canal usage that works within 10 minutes. Iontophoresis works by applying a gentle electric current in order to actively move charged drug molecules into the skin. In this particular case, positively charged lidocaine and epinephrine.
• Optimal anesthetic solution for iontophoresis. Dubbed "EMGIM", it contains 1:12,000 epinephrine with 3.3% lidocaine hydrochloride and 0.7% sodium bicarbonate. The solution is prepared fresh prior to use by combining 10 mL of 4% lidocaine hydrochloride with 1 mL of 1:1,000 epinephrine. After mixing the lidocaine and epinephrine, 1 mL of 8.4% sodium bicarbonate is added.
• Ear tube delivery device and placement system. Typically, a competent ENT can place an ear tube in about 10-20 seconds. However, when dealing with kids who may potentially move unexpectedly and operating within a very small ear canal space, a faster and more reliable way of placing a tube was required. Hence, this new device. [link]

Of course, during the actual procedure, age-appropriate distraction was needed to minimize movement, especially given aggressive restraint was not used.

Sounds great as sedation is something to be avoided if at all possible. However, there is one problem... the Acclarent iontophoresis device is NOT yet FDA approved contrary to what the report states (direct communication with Acclarent executives October 1, 2013). Hopefully in 2014. As such, beyond a research setting, this in-office technique is not yet available for use in the United States.

As an aside, there are FDA-approved iontophoresis devices for use in pediatric head and neck surgical procedures mainly for sub-cutaneous mass excisions and abscess incision and drainage. Check out Phoresor for such applications using lidocaine infused electrodes. It's even sold on Amazon.


References:
Otologic Iontophoresis: A No-Papoose Technique. Annals of Otology. Rhinology & Laryngology 122(8):487-491. Aug 2013.

In-Office Tympanostomy Tube Placement Under Local Anesthesia Using a Novel Tube Delivery Device. Triological Meeting Poster. Dec 2012.

Iontophoresis: a needle-free, electrical system of local anesthesia delivery for pediatric surgical office procedures. J Pediatr Surg. 1999 Jun;34(6):946-9.

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Yet Another Sinus Dilation Device - AerOS Sinus Dilation System

Sinus dilation has become all the rage in the past few years to treat chronic sinusitis, especially since CPT codes for this procedure has become available as of January 2012.

The first company was Acclarent who coined the balloon sinuplasty term.

Next was Entellus who produced their simpler system (XprESS and FinESS).

Now, there is SinuSys who has produced a new way to dilate the sinus opening without use of a balloon like Acclarent and Entellus. It is currently pending FDA approval, but is used in Europe.

This new system is called AerOs Sinus Dilation System and utilizes an osmotic self-expanding technology. A "simple" two-step insertion and removal of the device is required. Once inserted, the device gradually expands via low-pressure osmotic pressure in about 60 minutes. At that point, it can be removed.

The device itself is 5mm in size and exerts pressure of 2.5 ATM. The diameter is 3mm before dilation that ultimately expands to 5mm.

Compare this with Acclarent and Entellus balloon devices which are inflated to 12 ATM pressure and expands up to 7mm in size (depending on the model).

My personal concern with this device is the small size of 5mm... the surgeon will have to be super-precise for placement, otherwise, it'll fall out or do nothing.

Also, I question whether a 2mm dilation will actually make any difference. Prior studies have established that 4-5mm ostia size really is the minimal efficacious opening size. Larger is better, especially when the uncinate process is still intact as it would be in pure dilation cases. More study is required.

In any case, when (or if) this new device becomes available in the USA is unclear. It's all up to the FDA now.

Reference:
Feasibility of an osmotically driven, self-expanding device for sinus dilation to treat chronic sinusitis. Poster Presentation

Assessment of the short term patency of the maxillary sinus ostium following dilatation with an osmotic device in a sheep model. Jerome E. Hester, MD, David Edgren, BS, Andrea Koreck, MD, PhD, Jason Fox, BS, Janie Mandrusov, PhD, East Palo Alto, CA USA (Annual Meeting of American Rhinologic Society, September 2012, Poster# P-7).

Treatment of Maxillary Sinusitis Using the SinuSys AerOsTM Sinus Dilation System. White Paper 

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