Abstract
Purpose
To present the utility of ambulatory anesthesia using manually assisted ventilation via a facemask for tympanic membrane (TM) regeneration therapy in children.
Material and methods
The study included 10 children (age 4–11 years) in whom the duration of perforation before treatment exceeded 6 months and who were followed for at least 1 year after treatment between December 2009 and December 2012. Under ambulatory anesthesia using manually assisted ventilation via a facemask, TM regenerative therapy with atelocollagen combined with basic fibroblast growth factor was performed in children who could not tolerate the procedure under local anesthesia alone.
Results
All of the children completed the TM regenerative therapy under ambulatory anesthesia in less than 5 min. Complete closure was achieved in nine (81.8%) ears after 1 year of postoperative follow-up.
Conclusion
TM regenerative therapy can be performed under local anesthesia in less than 5 min without a skin incision. However, local anesthesia is often insufficient in small children undergoing this procedure. Therefore, ambulatory anesthesia using manually assisted ventilation via a facemask is appropriate to complete this procedure safely in small children.
1
Introduction
Acute tympanic membrane (TM) perforations in children caused by tube placement, infection, and trauma usually close after scarification of the edges without further intervention. However, chronic perforations that do not heal after several months often require surgical repair. Repair of the TM perforation using an autologous fascia or fat graft requires an umbilical or retro-auricle skin incision. For a minimally invasive approach, the paper-patch, an absorbable gelatin or atelocollagen patch, is commonly used, particularly in paediatric otolaryngology. To promote wound healing and improve the closure rate of TM perforations, we used human fibroblast growth factor (bFGF; Fiblast Spray®; Kaken Pharma, Tokyo, Japan) combined with a synthetic atelocollagen sponge/silicon membrane graft material (Terudermis®; Olympus Terumo Biomaterial, Tokyo, Japan) since 2000 . In adults, this procedure can be performed under local anesthesia in less than 5 min without a skin incision. However, local anesthesia is often insufficient in small children undergoing this procedure. General anesthesia might be appropriate in children undergoing a longer procedure, but for shorter procedures such as that described here, ambulatory anesthesia using manually assisted ventilation via a facemask is often appropriate. Therefore, we used brief sedation under manually assisted ventilation to complete this procedure safely in young children. This report describes the details of this treatment and discusses the outcome of patients with non-healing perforations for over 6 months’ duration who presented to our outpatient clinic over a 3-year period.
2
Materials and methods
2.1
Candidates for tympanic membrane regeneration therapy for children
The patients selected for regenerative therapy with brief sedation under manually assisted ventilation met the following criteria: (1) age 4–11 years with no clear evidence of cholesteatoma or malignancy in the middle ear; (2) the anterior rim of the perforation was clearly identified and was not hidden by the bulging anterior wall of the external auditory canal; and (3) chronic dry TM perforation present for at least 6 months with no sign of healing.
Candidates for TM regeneration therapy were selected based on their medical history and microscopic or fibrescopic findings of the TM or x-ray examinations. Fibrescopy allowed us to clearly identify marginal perforations, even when this was not possible microscopically. For patients with chronic adenotonsillar hypertrophy, an adenoidectomy was recommended before the regenerative therapy. Patients with otorrhoea or symptoms of sinusitis at the initial examination underwent TM regeneration therapy after stopping the otorrhoea reversibly and drying the TM or complete treatment of the sinusitis, such as with the administration of antibiotics.
Computed tomography (CT) was performed in all patients with otorrhoea; if CT revealed a suspicious shadow around the ossicles, at the back of the TM, or in the tympanic attic, the patient was excluded. In addition, patients with a secondary cholesteatoma arising from the perforation margin were excluded and advised to undergo tympanoplasty.
The outcome of TM closure was evaluated based on the condition of the TM assessed by microscopy, fibrescopy, and pure-tone audiometry at least 1 year postoperatively.
2.2
Tympanic membrane regeneration therapy with brief sedation using manually assisted ventilation via a face mask
For the TM regeneration therapy, we used human bFGF combined with a synthetic graft material (atelocollagen sponge/silicon membrane). The TM regeneration therapy method has been reported previously ; we describe it briefly below.
Thiamylal is an ideal sedative, with rapid onset of action and rapid recovery. One minute after the initial intravenous administration of 3–4 mg/kg of thiamylal, the children were given 1–2 μg/kg of fentanyl or 1–1.5 mg/kg of ketamine to provide analgesia. Anesthesia was maintained with a mixture of 5% sevoflurane and oxygen gas (4–5 L/min) using manually assisted ventilation via a facemask without intubation. The changes in pulse rate, respiratory rate, and oxygen saturation were monitored continuously using fingertip pulse waves and an electrocardiogram (ECG). Blood pressure was measured every 5 min.
Under an operating microscope, the perforation margin was dissected circumferentially with a sharp pick to expose fresh tissue.
The atelocollagen membrane was trimmed to an appropriate size with scissors and forceps and inserted in the perforation, ensuring that the silicon membrane faced outward and no gap remained. During this step, the silicon membrane should be trimmed into a circle slightly larger than the perforation to allow the membrane to fit the TM tightly, so that the atelocollagen membrane can be immobilised.
Using a long thin needle, 0.1–0.2 mL of bFGF solution was applied in the gap between the silicon membrane and perforation onto the atelocollagen membrane to complete the procedure. The entire procedure was completed in about 5 min.
When the treatment was finished, sufficient spontaneous respiration with respiratory sounds and oxygen saturation levels were confirmed. Patients were checked every 15 min for consciousness, vital signs, respiratory tract condition, and pain. They were allowed to drink water after they had regained consciousness and had not felt nauseous for at least 1 h after the completion of anesthesia. The child stayed one night in the hospital and was allowed to be taken home when he or she could drink water without vomiting, had maintained a normal body temperature for at least 1.5 h, and had passed urine spontaneously.
The silicon membrane was removed at a follow-up visit 2–3 weeks after the procedure.
This treatment procedure was approved by the Ethics Committee of Ehime University Hospital and was applied only to patients and their family who provided written informed consent.
2
Materials and methods
2.1
Candidates for tympanic membrane regeneration therapy for children
The patients selected for regenerative therapy with brief sedation under manually assisted ventilation met the following criteria: (1) age 4–11 years with no clear evidence of cholesteatoma or malignancy in the middle ear; (2) the anterior rim of the perforation was clearly identified and was not hidden by the bulging anterior wall of the external auditory canal; and (3) chronic dry TM perforation present for at least 6 months with no sign of healing.
Candidates for TM regeneration therapy were selected based on their medical history and microscopic or fibrescopic findings of the TM or x-ray examinations. Fibrescopy allowed us to clearly identify marginal perforations, even when this was not possible microscopically. For patients with chronic adenotonsillar hypertrophy, an adenoidectomy was recommended before the regenerative therapy. Patients with otorrhoea or symptoms of sinusitis at the initial examination underwent TM regeneration therapy after stopping the otorrhoea reversibly and drying the TM or complete treatment of the sinusitis, such as with the administration of antibiotics.
Computed tomography (CT) was performed in all patients with otorrhoea; if CT revealed a suspicious shadow around the ossicles, at the back of the TM, or in the tympanic attic, the patient was excluded. In addition, patients with a secondary cholesteatoma arising from the perforation margin were excluded and advised to undergo tympanoplasty.
The outcome of TM closure was evaluated based on the condition of the TM assessed by microscopy, fibrescopy, and pure-tone audiometry at least 1 year postoperatively.
2.2
Tympanic membrane regeneration therapy with brief sedation using manually assisted ventilation via a face mask
For the TM regeneration therapy, we used human bFGF combined with a synthetic graft material (atelocollagen sponge/silicon membrane). The TM regeneration therapy method has been reported previously ; we describe it briefly below.
Thiamylal is an ideal sedative, with rapid onset of action and rapid recovery. One minute after the initial intravenous administration of 3–4 mg/kg of thiamylal, the children were given 1–2 μg/kg of fentanyl or 1–1.5 mg/kg of ketamine to provide analgesia. Anesthesia was maintained with a mixture of 5% sevoflurane and oxygen gas (4–5 L/min) using manually assisted ventilation via a facemask without intubation. The changes in pulse rate, respiratory rate, and oxygen saturation were monitored continuously using fingertip pulse waves and an electrocardiogram (ECG). Blood pressure was measured every 5 min.
Under an operating microscope, the perforation margin was dissected circumferentially with a sharp pick to expose fresh tissue.
The atelocollagen membrane was trimmed to an appropriate size with scissors and forceps and inserted in the perforation, ensuring that the silicon membrane faced outward and no gap remained. During this step, the silicon membrane should be trimmed into a circle slightly larger than the perforation to allow the membrane to fit the TM tightly, so that the atelocollagen membrane can be immobilised.
Using a long thin needle, 0.1–0.2 mL of bFGF solution was applied in the gap between the silicon membrane and perforation onto the atelocollagen membrane to complete the procedure. The entire procedure was completed in about 5 min.
When the treatment was finished, sufficient spontaneous respiration with respiratory sounds and oxygen saturation levels were confirmed. Patients were checked every 15 min for consciousness, vital signs, respiratory tract condition, and pain. They were allowed to drink water after they had regained consciousness and had not felt nauseous for at least 1 h after the completion of anesthesia. The child stayed one night in the hospital and was allowed to be taken home when he or she could drink water without vomiting, had maintained a normal body temperature for at least 1.5 h, and had passed urine spontaneously.
The silicon membrane was removed at a follow-up visit 2–3 weeks after the procedure.
This treatment procedure was approved by the Ethics Committee of Ehime University Hospital and was applied only to patients and their family who provided written informed consent.
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