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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Local Anesthetic Allergy

Rarely, a patient presents with a history of being allergic to lidocaine or another kind of local anesthetic. Often, the "allergic" reaction described (racing heart, light-headed, dizziness, etc) is more attributable to the epinephrine which is often used in conjunction with the anesthetic; therefore not a true allergy, but a not unexpected possible side effect.

Also, if a true allergy is present, it may not be to the anesthetic itself, but the preservative contained within, typically metabisulfite and/or methylparaben. The exception are single-dose vials which are preservative-free, unless they contain epinephrine. Any local anesthetic containing epinephrine, whether a single-dose or multi-dose vial, has metabisulfite in it. The preservative in the multi-dose vial of lidocaine and other anesthetics typically contain methylparaben. As such, the muti-dose vial of lidocaine with epinephrine would contain both metabisulfite and methylparaben.

In any case, if a true allergy to the anesthetic itself is present, there is the possibility that another type of anesthetic can be used. Why?

There are two different classes of local anesthetics divided into amino esters and amino amides. Chemically, amino amides have an amide link between the intermediate chain and the aromatic end, whereas amino esters have an ester link between the intermediate chain and the aromatic end.

Amino Ester

Amino Amide

There are other differences. Pharmacologically, amino esters are metabolized in the plasma whereas amino amides are metabolized in the liver. Amino esters are unstable in solution, but amino amides are very stable in solution.

Amino esters are also much more likely than amino amides to cause allergic hypersensitivity reactions.

Amino Esters (only one "i" in the spelling of the name):

• Cocaine
• Procaine
• Tetracaine (in the form of cetacaine)*
• Chloroprocaine*
• Benzocaine (in the form of cetacaine)*
• Cetacaine (benzocaine and tetracaine)*
• Propoxycaine

Amino Amides (two "i"'s in the spelling of the name):

• Lidocaine*
• Mepivacaine*
• Prilocaine
• Bupivacaine*
• Ropivacaine*
• Levobupivacaine
• Articaine
• Etidocaine
• Trimecaine
• EMLA (lidocaine/prilocaine)

* is next to those commonly carried in hospitals.

Much appreciate the assistance of Margaret Rowe, PharmD who helped write this blog article.

Source:
Local Anesthetics. Emedicine 4/19/13

Local Anesthetic. Wikipedia

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Why Patients Travel a Long Distance for Care

The decision for a patient to travel hours away for their medical care is a highly personal decision or a matter of necessity, especially if the care is unavailable locally.

Assuming care IS available locally, based on my own personal observations, the reason to travel for medical care ultimately is due to level of anxiety... either the patient or the surgeon.

Patient A:

I recently saw a patient with a small parotid tumor... about 1.5cm in size that was confirmed on needle biopsy to be a pleomorphic adenoma. Ultimately, the decision for surgery was pursued... but the patient wanted to go elsewhere to have the surgery done even though the patient understood I was perfectly competent to perform the resection.

Why? Because of the high anxiety and concern for the risk of facial paralysis associated with the surgery. The patient perceived her risk of this complication would be smaller if she went elsewhere.

Such patients, like Patient A, typically have certain characteristics:

• Type A personality
• Young (20-40s)
• Never had surgery before
• Surgery has a significant risk associated with it

Patient B:

In another patient who I saw a few months prior to patient A, same scenario, but the parotid tumor was 4cm in size and located in the deep lobe. Decision for surgery was also pursued, but this time, I as the surgeon recommended the patient to go elsewhere to have the surgery done.

Why? Because of the high anxiety and concern for the risk of facial paralysis associated with the surgery. I perceived the risk of this complication would be smaller if he went elsewhere where this type of surgery is frequently performed. This particular patient desperately asked and ultimately begged that I perform the surgery. He really did not want to travel to get the surgery done. However, I explained to the patient that based on size and location, the risk for facial paralysis was quite significant. If it was smaller, like in Patient A, I would have felt perfectly comfortable in performing the surgery.

Patient B ultimately did go elsewhere to have the surgery done... and did, unfortunately, suffer from facial paralysis afterwards.

However, I was happy to provide routine post-op follow-up care given it was more geographically convenient for the patient.


Such patients, like Patient B, typically have certain characteristics:

• Older (50+)
• Has had surgery before

Issues With Long-Distance Care

Regardless of innate patient characteristics, having surgery done a long-distance away is a pain for the patient. Think of the travel, expense, missed time from work, etc NOT just for the surgery, but for any post-operative problems that develop. Oftentimes, the patient concern ends up being unfounded and only reassurance is required, but in order to make that determination, the surgeon needs to do an exam. Imagine the frustration of the patient when a surgeon requests a visit before answering a question about a post-surgical concern... hours of driving to the office, waiting in the exam room, being seen by the surgeon for a few minutes only to hear that everything is fine and normal, and finally driving hours back home.

Even in the hands of the BEST surgeon, problems can arise after surgery. Is the surgical wound becoming infected? Where is that fever coming from? There's a little drainage occurring... is that normal? Why is the skin red? There's a lot of pain and his medications aren't working.

To complicate things further, narcotic pain killers can NOT be called in by federal rules. A hardcopy prescription is required. Now, wouldn't that be mighty inconvenient if a patient (who mind you is in pain), needs to drive hours to the surgeon's office just to pick up a hardcopy narcotic prescription.

The logistical difficulties of dealing with post-operative care after patient discharge is tremendous for both the surgeon as well as the patient if the distance between the two is large.

How to Make Long-Distance Care Easier for the Patient

DO see your most appropriate local doctor and discuss your medical case with him/her. If decision to pursue surgery a long-distance away is made, DO keep your local doctor in the loop.

Routine post-operative care can all be provided locally. Suture removal can be done locally. Infection evaluation can be done locally.

The decision to have surgery a long-distance away was due to concern of risks inherent to the surgery itself... not the care afterwards and as such, such post-operative care can all be provided locally by a competent physician.

Of course, if there's significant concern, the patient can always travel back to the original surgeon, but most often, this travel is unnecessary.

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12 Years Old Girl Dies After Tonsillectomy

Tampa Bay Times reported on June 10, 2012 a 12 years old girl died after a tonsillectomy performed on Aug 13, 2010 for chronic tonsillitis. From the details provided from the news report, it seems that several independent issues all contributed together that lead to this child's unfortunate and tragic death.

This case was also complicated by subsequent non-medically related actions taken by medical personnel which will not be discussed here.

Strictly medically speaking...

Local Anesthetic With Epinephrine

It is unclear exactly when the local anesthetic bupivacaine (Marcaine) with epinephrine was injected into the tonsil region which may help with post-tonsillectomy pain control in the pediatric population. Also unclear is what concentration and how much got injected.

However, it is far from common practice (though not rare) and it is not something I personally inject in the pediatric population for a few reasons in spite of its well-known suspicion to minimize a sore throat after surgery. (There are plenty of papers that report such injection offers NO additional pain control in children. See references below.)

1) The risk of bupivacaine is toxicity to the heart leading to arrhythmias that may ultimately lead to a heart attack.
2) Epinephrine can result in hypertension as well as further exacerbate cardiac problems

Given report of "bloody froth" in the endotracheal tube along with acute onset of tachycardia and hypertension, I suspect the child suffered from pulmonary edema, most likely secondary to accidental intra-vascular injection of the local anesthetic (causing cardiac failure) and epinephrine (causing tachycardia and hypertension).

Given these risks and fact that kids are so much smaller and more susceptible to medication risks, I personally never inject this medication during/after tonsillectomy. Even in adults, I never inject routinely, though I do offer to adults undergoing tonsillectomy (but than I use bupivacaine alone without epinephrine).

The hypertension itself led to problem #2...

Congenital Cerebellar Vascular Anomaly

The child had a congenital cerebellar vascular anomaly that ruptured leading to a life-threatening bleed in the brain.

In and of itself, this anomaly would not have been a problem, but given the reported sudden hypertension, the rupture is akin to inflating a tire with too much air causing it to pop.

Most likely, if the child's cardiovascular compromise never occurred, this bleed never would have happened in the first place.

It's also entirely possible if the local anesthetic was never used, this death would not have happened as well.


Source:
Lawsuit claims doctors' mistakes caused Palm Harbor girl to die after tonsillectomy. Tampa Bay Times 6/10/12.


References:
Comparison of clonidine, local anesthetics, and placebo for pain reduction in pediatric tonsillectomy. Arch Otolaryngol Head Neck Surg. 2011 Jun;137(6):591-7. Epub 2011 Mar 21.

Preincisional bupivacaine in posttonsillectomy pain relief: a randomized prospective study. Arch Otolaryngol Head Neck Surg. 2002 Feb;128(2):145-9.

Control of early postoperative pain with bupivacaine in pediatric tonsillectomy. Ear Nose Throat J. 1993 Aug;72(8):560-3.

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