Introduction
Tympanostomy tube insertion is one of the most common ambulatory surgical procedures performed in children in the United States. It is commonly used in the treatment of recurrent or refractory acute otitis media (AOM) or chronic otitis media with effusion (OME), which are more common in younger children. Most tympanostomy tube insertions are performed under general anesthesia (GA) due to unavailability of reliable and effective local anesthesia of the ears in children and the fear of doing the surgery while the child is moving. Many parents are concerned about exposing their children to GA, which comes with a Food and Drug Administration recommendation to limit the use of a single general anesthetic for more than 3 hours or multiple general anesthetics for children younger than 3 years, as data suggested these exposures may affect long-term brain development in young children. Being the most common ambulatory procedure that often requires GA, it carries a substantial economic cost for health care systems. For these reasons, innovations in office tympanostomy tube insertion are warranted to reduce costs and minimize GA exposure in children. This chapter discusses the indications, technique, preparation and local anesthesia, and advances in tympanostomy tube insertion in the clinic setting.
Indications
The indications for tympanostomy tube insertion in children described in this chapter are based on clinical practice guidelines developed by the American Academy of Otolaryngology–Head & Neck Surgery. Children with chronic OME, defined by the presence of middle ear effusion for 3 months or longer from the date of onset or diagnosis and confirmed hearing impairment, are eligible for tympanostomy tube insertion. Tubes can be used to treat chronic OME and symptoms that are likely due to OME, such as vestibular symptoms, poor school performance, behavioral issues, ear discomfort, or reduced quality of life . Tubes can also be offered to children with recurrent AOM, defined as three or more well-documented and separate AOM episodes in the last 7 months OR at least four episodes in the last year with at least one episode in the last 6 months, who have unilateral or bilateral middle ear effusion at the time of tube candidacy assessment. For children at risk, such as those with permanent hearing loss independent of OME, speech and language delay, autistic disorder, syndromes, blindness, cleft palate, developmental delay, and learning disabilities, tympanostomy is considered on a case-by-case basis, and tubes may be recommended if the effusion is likely to persist. Tubes are also considered for refractory and complicated AOM.
Technique
The purpose of this section is to discuss and describe the various preparations and techniques for in-office tympanostomy tube placement.
Patient Selection
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A thorough medical history is obtained to confirm if the patient meets the indications for tube placement.
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Pneumatic otoscopy and microscopy are performed to confirm the diagnosis. The external auditory canal should be assessed with the microscope to determine whether it is large enough to perform the procedure in clinic. Syndromic children such as children with Down syndrome, as well as those with a small external auditory canal or stenosis, are not suitable candidates for the in-office procedure. Additionally, children with severely retracted tympanic membranes should not undergo the procedure in a clinic setting.
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It is important for the otolaryngologist to select the appropriate patient and family for the in-office procedure. If there is any evidence of anxiety or fear while interviewing the child and family, the procedure in the clinic will be challenging. If the family agrees to the in-office procedure, the child’s willingness must be assessed. In our experience, this can be accomplished by examining the child under the microscope and performing a gentle ear cleaning. If the child shows signs of fear or starts to move, this may indicate that the in-office procedure will be challenging. After ensuring that the child and family are ready, consent is obtained, and one proceeds with patient preparation for the intervention.
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Preoperative age-appropriate hearing assessment and tympanometry should be performed prior to surgery.
Patient Preparation
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Behavioral strategies have been shown to be effective in preparing the children and families. Cohen and colleagues described a behavioral program that consisted of providing the child with a storybook titled, “We’re going to the ear doctor!” The story describes the surgical steps using reframing. For example, the child in the story feels the squish of cold medicine in the ears, which feels like a bubble bath. Such preparation improves child and family cooperation.
Medications
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Oral pain medication such as acetaminophen (Weight-based dosing) or nonsteroidal antiinflammatory drugs (NSAIDs) such as ibuprofen (Weight-based dosing) is administered 30 minutes to 1 hour before the procedure.
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Another alternative is the use of nitrous oxide, as it has been demonstrated to have a good analgesic effect. There are self-administered devices designed to deliver a mixture of 50% nitrous oxide and 50% oxygen, providing analgesia for brief procedures when patients are breathing spontaneously. These products include Nitronox by Porter Instrument (Hatfield, PA) and Entonox by The Linde Group (Munich, Germany). , Although the US Food and Drug Administration (FDA) has not yet given Entonox approval, it is sanctioned and widely used in Europe and Australia. The FDA has approved Nitronox and it is widely used in the United States. ,
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These devices can be controlled by the patient or well-trained nurses throughout the procedure. Nitrous oxide onset is within minutes, reaching peak effectiveness within 3 to 5 minutes, and the patient quickly recovers within 30 minutes after discontinuation. , , Some potential side effects include dizziness, light-headedness, nausea, and vomiting. , , Nitrous oxide should be avoided in patients with a history of head trauma, recent eye surgery, vitamin B12 deficiency, pernicious anemia, impaired consciousness, airway compromise, and situations where gas expansion within a confined space, such as tension pneumothorax, is a concern. The use of nitrous oxide may not be permitted in clinic settings.
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Positioning will be determined by the child’s age and activity level. Infants and young children can be swaddled with a blanket and held by trained assistants or restrained on a papoose board ( Fig. 12.1 ). For older children who can cooperate, family members can help hold the hands and body while a trained assistant holds the head ( Fig. 12.2 ).
Fig. 12.1 Papoose board.
Fig. 12.2 A trained assistant holding the child’s head and hands.
Local Anesthesia
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The topical anesthetic cream EMLA cream (lidocaine 2.5% and prilocaine 2.5%) is applied over the tympanic membrane in a layered fashion to cover the eardrum and fill the external auditory canal. This can be performed using a 1- or 3-mL syringe connected to a curved suction tip ( Fig. 12.3 ). This method allows for direct cream application without obstructing the view ( Fig. 12.4 ). This local anesthesia approach offers several advantages, including painless application, effective anesthesia in both the ear canal and the tympanic membrane, thereby reducing discomfort caused by ear speculum or other instruments rubbing the external auditory canal. A drawback is the need to suction the cream once it has taken effect. The cream is left in place for 20 to 30 minutes and then suctioned to ensure complete removal. It is important to suction all the cream to prevent its entry into middle ear after the myringotomy, as this can lead to significant vestibular symptoms. Other topical cream options, such as tetracaine 8% or tetracaine hydrochloride 4% (AMETOP Gel 4%), or MAXILENE cream (4% lidocaine), can also be used.
Fig. 12.3 Curved suction tip connected to a 3-mm syringe.
Fig. 12.4 Curve suction tip allows for direct cream application while preventing hands from obstructing the view.
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Another method is to inject lidocaine with or without epinephrine into the external auditory canal with a 3-mL syringe and a small-gauge needle. It is important to calculate the lidocaine dose based on the weight of the child. The drawback is the pain, discomfort, and anxiety caused by the injection.
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An alternative is the use of iontophoresis. This is a technique for administering local anesthesia through the skin using an electric current. Iontophoresis has been described as an excellent method to delivering local anesthesia to the ears. Epley reported the success of iontophoretic administration of a lidocaine and epinephrine solution in 59 children. A more detailed description of the combined iontophoresis system and automated tube delivery system will be covered in a later section.
Surgical Procedure
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Instruments required for performing the myringotomy and tube insertion are shown in Fig. 12.5 .
Fig. 12.5 Instruments required for performing myringotomy and tube insertion.
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Using an operating microscope with 250-mm focal length, and the largest possible beveled speculum in the ear canal, a radial incision is made using a myringotomy knife in the tympanic membrane ( Fig. 12.6 ). A fine suction is used to remove the middle ear fluid and the tube is placed in the incision.
Fig. 12.6 (A) Anteroinferior quadrant of the right tympanic membrane is outlined by the black lines . Cone of light is visible. (B) Radial incision at the anteroinferior quadrant of the tympanic membrane of the right ear using a myringotomy knife. (C) Myringotomy opening is seen.
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Various locations for the myringotomy and tube placement have been described in the literature, including the anterosuperior and anteroinferior quadrants of the tympanic membrane. Paparella proposed placing the tubes in the anterosuperior quadrant to avoid important middle ear structures, and the location is closely related to the protympanum of the eustachian tube. Furthermore, based on epithelial migratory patterns, it has been proposed that tubes inserted anterosuperiorly last longer than those placed inferiorly. Hern and Jonathan found no difference in extrusion rate when comparing tubes in the anterosuperior and anteroinferior quadrants of the tympanic membrane. Tubes placed anterosuperiorly, on the other hand, would migrate toward the anterior annulus, as opposed to tubes inserted anteroinferiorly, which tend to migrate posteriorly.
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The authors prefer to place the tubes at the lower edge of the anteroinferior quadrant ( Fig. 12.6 ). This quadrant offers better visibility and reduces the likelihood of encountering the anterior canal hump during tube insertion, which is particularly crucial for in-office procedures to prevent any contact with the ear canal. Radial incisions are parallel to epithelial migration, and thus, tubes placed in a radial incision are less likely to extrude. Considering the migration pattern of the anteroinferior quadrant is generally toward the posterior region, having tubes placed anteroinferiorly would facilitate easier repair of a posterior defect, if any residual perforation remains, as opposed to an anterior defect caused by tubes placed anterosuperiorly.
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Types of tubes: First, the desired tube is grasped with an alligator forceps, and the leading edge of the tube is placed into the myringotomy site and kept in place ( Fig. 12.7 ). The tube is then carefully advanced by pushing the other end using alligator forceps or a Rosen needle until it is fully positioned ( Fig. 12.8 ). There are various materials and designs for tympanostomy tubes, however they are broadly classified as short-term and long-term tubes. The Donaldson ear tube, Paparella I tube, Armstrong grommet ventilation tube, Sheehy grommet, Reuter bobbins myringotomy tube, and Shepard myringotomy tubes are among the commonly used short-term ventilation tubes ( Fig. 12.9 ). These tubes feature both inward and outward flanges and typically remain in the tympanic membrane for a duration of 6 to 18 months. , Long-term ventilation tubes, which are designed to resist extrusion forces, can remain in the tympanic membrane for a period of 15 to 18 months, with some even lasting longer than 2 years. These tubes are characterized by a more prominent inward flange or the absence of an outward flange. Examples of such long-term tubes include Paparella II, Per-Lee tube, Armstrong beveled ear tube, Butterfly tube, and Goode T-tube , ( Fig. 12.10 ).
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The authors prefer using smaller short-term tubes, such as straight shank tubes, during an in-office tube procedure. Reuter Bobbins tubes are also commonly used.
Fig. 12.7 (A) Reuter Bobbin ear tube is grasped by an alligator forceps (from the lower flange). (B) Another figure showing a Reuter Bobbin ear tube grasped from the top flange. (C) The leading edge of the Reuter Bobbin ear tube is placed into the myringotomy site and kept in place.
Fig. 12.8 (A) The ear tube is carefully advanced by pushing the other end using an alligator forceps or a Rosen needle. (B) Ear tube is fully positioned.
Fig. 12.9 Examples of short-term ventilation tubes:
(A) Reuter Bobbin ear tube.
(B) Straight Shank ear tube.
Fig. 12.10 Examples of long-term ventilation tubes:
Goode T-Tube (Green)
Richards T-Tube (Blue).
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Automated Tube Delivery Systems
In this section, we describe innovative combined systems currently available.
Two complementary technologies have been used to facilitate the placement of tympanostomy tubes in children in an office setting. The first technology involves the utilization of an advanced iontophoresis system (IPS), which administers local anesthesia medication to the tympanic membrane and skin using a low-level electrical current. The second technology involves the use of an automated myringotomy and tube-delivering system (TDS). A study conducted by Zeiders et al. used the IPS and TDS developed by Acclarent, Inc., based in Menlo Park, CA. The IPS device uses a direct current generator that delivers electrical current (maximum 0.8 mA) through electrodes embedded in earplugs. These earplugs assist in containing the anesthetic medication within the ear canal, with an average dwell time of approximately 10 to 15 minutes. The study used a mixture of 4% lidocaine HCl, 1:1000 epinephrine, and 8.4% sodium bicarbonate in a ratio of 10:1:1. The TDS system performs the myringotomy, dilates the incision, inserts a preloaded silicone Paparella-style tube, and then rapidly retracts all sharp objects in less than 1 second. The study reported a successful placement rate of tympanostomy tubes of 96.6% in 70 children, with highly favorable ratings for overall satisfaction (96.9%). Another treatment package called The Tula system, developed by Tusker Medical, Inc., a subsidiary of Smith+Nephew (Austin, TX), consisted of the Tymbion iontophoresis system using 2% lidocaine HCll and 1:100,000 epinephrine for local anesthesia and the Tula tube delivery system. In a multicenter prospective cohort study conducted by Lustig et al., The Tula system was used on 222 children diagnosed with OME. The study reported a successful placement of tubes in 85.8% (103/120) of children under the age of 5 and in 89.2% (91/102) of older children. No serious complications were reported, and the incidence of otorrhea, tube occlusion, and perforation was similar to those observed in children who underwent the procedure in the operating room. In a recent study by Waldman et al., comparable findings were presented regarding 269 children who underwent tube placement using The Tula system. The study indicated that these children exhibited tube sequelae resembling grommet-type tubes, and the rates of complications observed were in line with those typically associated with traditional tube placement in the operating room. Other systems available are the Hummingbird TTS (Preceptis Medical) and the Solo TTD (AventaMed). , Truitte et al. conducted a multicenter prospective nonrandomized study involving 229 children, using the Hummingbird TTS (Preceptis Medical) system for tympanostomy tube placement in an office setting. The study reported a high success rate, with 98.7% of the procedures resulting in successful tube placement. They reported two events of early tube extrusion and tube dislocation into the middle ear in a single patient, which were attributed to patient movement. Many studies have a small sample size and lack quality data on key factors such as the median duration of tube placement, the incidence of otorrhea, and other post-tube complications. Moreover, these devices come with a considerable cost, necessitating further cost-benefit analyses when compared to the standard in-office tympanostomy tube procedure or those conducted under general anesthesia.
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The Tula system ( Fig. 12.11 shows the system components and the procedure steps):
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Clean the ear canal to remove any wax, debris, or visible oil.
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Use an earplug sizer to get the right fit. The earplug should be comfortable for the patient while providing a solid seal. Once the earplug size has been determined, an earset is chosen from two sizes based on the patient’s age: regular or long.
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Prepare the control unit and attach the return electrode on the skin.
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Attach the earplug to the earset and insert it into the external auditory meatus.
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The earset is then connected to the control unit.
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Fill the ear canal with the medication provided by the manufacturer (TYMBION = 2% lidocaine HCl and 1:100,000 epinephrine). To avoid dizziness, ensure that the drug is warm ( Fig. 12.12 ).
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