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Anesthetic Complications of Tympanostomy Tube Placement in Children
Karen K. Hoffmann, MD;
G. Kevin Thompson, MD;
Bonnie L. Burke, MS;
Craig S. Derkay, MD
Arch Otolaryngol Head Neck Surg. 2002;128:1040-1043.
ABSTRACT
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Objective To determine the incidence of perioperative anesthesia complications
during bilateral myringotomy with tympanostomy tube placement (BMTT).
Setting Tertiary care children's hospital where otolaryngology attending physicians
and residents performed surgical procedures. Anesthesia providers included
pediatric anesthesiologists, residents, nurse anesthetists, and students.
Methods Medical record review was performed for a consecutive series of 3198
children undergoing BMTT (1000 prospectively, 2198 retrospectively). For the
prospectively studied patients, major adverse events, which included laryngospasm
and stridor, and minor adverse events, including upper airway obstruction,
prolonged recovery, emesis, and persistent postprocedural agitation, were
noted. Also recorded were the patient's American Society of Anesthesiologists
(ASA) physical class status, age, concurrent medical conditions, and type
of anesthesia provider.
Results Fewer than 9% of prospectively studied pediatric patients experienced
a minor adverse event, whereas a major event occurred in 1.9%. Eighty-one
percent of the events experienced were attributable to agitation or prolonged
recovery. Neither ASA status (P = .38), age (P = .15), nor type of anesthesia provider (P = .06) were significantly related to the occurrence of an adverse
event. However, a child with an acute or chronic illness has 2.78 times the
odds of experiencing an adverse event compared with a child with no illness
(P<.001).
Conclusions Anesthesia administered for placement of tympanostomy tubes by physicians
who specialize in the care of children in a tertiary care children's hospital
is safe. The most significant predictor of a minor anesthetic event during
BMTT is the presence of a preexisting medical condition or concurrent acute
illness.
INTRODUCTION
BILATERAL myringotomy with tympanostomy tube placement (BMTT), usually
performed with mask ventilation with the patient under general anesthesia,
continues to be one of the most commonly performed surgical procedures in
children in the United States. Past studies1
have demonstrated that anesthesia given for this procedure is "relatively
safe," with a low incidence of adverse effects. The complications directly
related to BMTT have also been well documented. This study seeks to prospectively
and retrospectively document the intraoperative and immediate postoperative
anesthetic adverse events associated with this brief surgical procedure.
During the past several years, much emphasis has been placed on improving
the quality of medicine. It has been shown that tympanostomy tubes produce
large short-term improvements in quality of life for most children.2 Hospitals also now routinely monitor poor patient
outcomes, including morbidity and mortality, in an attempt to improve the
care of patients. There is little evidence to document the usefulness of these
quality improvement programs in accurately recording perioperative complications
to improve patient outcomes.
This study had several goals. The first was to determine the incidence
of perioperative anesthesia complications during BMTT. The second was to compare
the incidence of adverse events during placement of tympanostomy tubes recorded
through an active monitoring system with the incidence reported using a passive,
unenforced monitoring system. Third, we aimed to determine the relationship,
if any, between a patient's American Society of Anesthesiologists (ASA) physical
class status, age, level of staff expertise, and presence of concurrent medical
conditions to the occurrence of adverse events.
PATIENTS, MATERIALS, AND METHODS
The study was conducted at the Children's Hospital of the King's Daughters,
Norfolk, Va, a tertiary care children's hospital. A total of 3198 patients
underwent BMTT for indications of recurrent acute otitis media and chronic
otitis media during the study period. The surgical procedures were performed
by otolaryngology attending physicians and residents. Anesthesia providers
included pediatric anesthesiologists, residents, nurse anesthetists, and students.
Fellowship-trained pediatric anesthesiologists supervised all anesthesia providers.
Induction was accomplished with mask anesthesia using halothane, oxygen, and
nitrous oxide. All patients were given ibuprofen at standard doses (10 mg/kg)
orally 30 to 60 minutes before induction of anesthesia.
A consecutive series of 1000 children was studied prospectively between
November 1, 1998, and March 31, 2000. A data sheet was placed in the medical
record of each child undergoing BMTT, and the anesthesia provider collected
the information. The ASA status3 was used in
an attempt to categorize the severity of illness (not including middle ear
disease) for each patient (Table 1)
before surgery. Data collected also included the age of the patient, concurrent
or chronic medical conditions, level of anesthesia staff, anesthesia technique
if different from the standard (halothane, oxygen, nitrous oxide), intraoperative
and postoperative adverse events, treatment initiated in case of an adverse
event, and outcome.
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Table 1. American Society of Anesthesiologists (ASA) Physical Classification
System
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Major adverse events included laryngospasm, bradycardia, stridor, decreased
oxygen saturation greater than 10% of baseline, and dysrhythmia. Minor adverse
events included upper airway obstruction (transient loss of glossal and pharyngeal
muscle tone), prolonged recovery longer than 30 minutes, emesis, and persistent
agitation. Agitation was a subjective measure that was determined by recovery
room nursing staff experienced in the care and recovery of pediatric surgical
patients.
Complications documented as part of a hospital quality improvement program
in a series of 2198 consecutive patients during a 3-year period were evaluated
retrospectively. Under this passive surveillance system, the anesthesia provider
recorded complications that occurred during a surgical procedure on a data
sheet, and the information was entered into the computer system by the anesthesia
administrative staff.
Concurrent medical conditions included upper respiratory tract infection
(URI) the day of surgery, reactive airway disease (RAD), chronic pulmonary
disease, gastroesophageal reflux disease (GERD), and other (congenital heart
disease, chromosomal anomalies including trisomy 21, cerebral palsy, hydrocephalus,
attention-deficit/hyperactivity disorder, and seizure disorder). These conditions
were grouped according to type and frequency and related to the occurrence
of specific adverse events.
The  2 test and logistic regression analysis were used
to evaluate the association and the strength of the association between the
occurrence of any adverse event and proposed predictors. A large sample test
of proportions was conducted to test a difference in incidence of any adverse
event. A generalized logit model was fit to determine the predicted probability
of a specific adverse event given a child's medical condition. Significance
was declared at P<.05. Analysis was conducted
using STATA 6.0 software (Stata Corp, College Station, Tex).
RESULTS
Active monitoring recorded adverse events in 8.8% of children undergoing
BMTT who were studied prospectively, whereas major events occurred among 1.9%.
All patients were discharged home the same day as the procedure; there were
no admissions, no consultations required from other services, and no deaths
during this study period. Table 2
lists the classification and frequency of adverse events recorded. Note that
11 patients (1.1%) experienced more than one adverse event.
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Table 2. Frequency of Perioperative Adverse Events
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Of the 2198 operative cases studied retrospectively, 3 adverse events
(0.1%) were documented using passive surveillance. All recorded events involved
laryngospasm, with 1 patient requiring intubation and 2 cases of spontaneous
resolution with supportive care. A significantly greater number of events,
104 (incidence, 10.4%), was reported in the 1000 cases using prospective,
active monitoring (P<.001). Subsequent results
reflect only the 1000 patients studied under the active monitoring system.
Table 1 demonstrates the
distribution of ASA status with the observed incidence of any adverse event.
There was a higher incidence of adverse events in patients classified as having
a physical class status of ASA 2 when compared with patients classified as
having a status of ASA 1, 3, or 4. Although there was no statistically significant
relationship between ASA status and the occurrence of an adverse event overall,
the number of patients with an ASA 3 or 4 status was very small, creating
a low statistical power and an inability to detect a relationship. The incidences
of adverse events for patients grouped by age were as follows: 0- to 1-year-old
patients, 9.5% (17/178); 1- to 3-year-old patients, 10.9% (49/450); 3- to
6-year-old patients, 7.5% (18/239); and patients 6 years and older, 15.0%
(20/133). No association between age and the occurrence of an adverse event
was found (P = .14).
The most commonly noted concurrent medical conditions in this patient
population with middle ear disease were URI (25.3%), RAD (31.6%), chronic
pulmonary disease (35.3%), and GERD (19.4%). In addition, there is a significantly
higher prevalence of adverse events in patients with other medical conditions
(13.0%) compared with children with no concurrent medical conditions (7.7%).
Additionally, the probability of experiencing an adverse event is greater
for a patient with a medical condition vs one with no medical condition (Table 3). Of the 104 patients experiencing
an adverse event, only 4 patients (3.8%) had congenital heart disease, chromosomal
anomalies, cerebral palsy, hydrocephalus, or seizure disorder. None of these
patients experienced multiple adverse events.
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Table 3. Predicted Probability of an Adverse Event for a Given Medical
Condition*
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Overall, the type of anesthesia provider was not a significant predictor
of the occurrence of an adverse event (P = .06).
All anesthesia providers were supervised by attending pediatric anesthesiologists,
and no differences in the occurrence of adverse events were found when comparing
attending anesthesiologists to nurse anesthetists or students. Twelve occurrences
of persistent agitation or prolonged recovery were recorded when a resident
was an anesthesia provider (n = 60), for a relative risk of an event of 2.3
(95% confidence interval, 1.28-4.12; P = .006), when
compared with anesthesia administration by a staff anesthesiologist. However,
there was not a higher incidence of major adverse events when the resident
was the anesthesia provider.
COMMENT
The ability of the hospital quality improvement program to provide useful
information for changing medical practice was evaluated by comparing the data
obtained from retrospective analysis of 2198 patients who underwent BMTT to
the data obtained from 1000 patients studied prospectively. Three episodes
of laryngospasm were recorded with the passive monitoring system (incidence,
0.1%), whereas 104 events (incidence, 10.4%) were recorded with the active
monitoring system. Of the events recorded prospectively, 86.5% were classified
as minor events, and 13.5% were classified as major events. It is likely that
only major events would be recorded through a voluntary reporting system such
as the quality improvement program. Even when comparing only the number of
major events documented in the 2 systems, more events were reported with the
active monitoring system. A possible reason for this is that there was no
stated penalty for noncompliance with the passive monitoring system and little
incentive for individuals to participate. Such a program would be less likely
to change practice patterns or improve patient outcomes.
There are few perioperative anesthetic complications associated with
BMTT. Indeed, only 8.8% of children experienced a minor event, 1.9% experienced
a major event, and no patient required admission to the hospital. All events
were successfully treated without significant or long-term morbidity. Most
adverse events (81%) recorded were attributable to agitation (57/104) and
prolonged recovery of more than 30 minutes (27/104). This study attempted
to calculate the frequency of events related to the administration of general
anesthesia for the placement of tympanostomy tubes. Although persistent agitation
and prolonged recovery are not truly complications of the administration of
general anesthesia, the authors believed that these were common occurrences
that should be documented. Both persistent agitation and prolonged recovery
are subjective measures of the degree of impairment of the patient postoperatively,
as determined by the experienced nursing staff and supervising fellowship-trained
pediatric anesthesiologists, respectively. No attempt was made to quantify
the degree of agitation apart from allowing descriptions by the nursing staff;
everything from "fussy" to "totally inconsolable" was included under this
heading. Prolonged recovery was a measure of the sleepiness of the patient
after the procedure. The benefit of including these subjective events in the
study is to relay to parents that both agitation and sleepiness are common
and expected occurrences after general anesthesia and that they resolve without
sequelae. If agitation and prolonged recovery are not included as adverse
events, then the number of minor adverse events decreases significantly to
25 (incidence, 2.5%).
The most commonly occurring events requiring some form of intervention
in this study were upper airway obstruction (n = 9), laryngospasm (n = 9),
and cardiac dysrhythmia (n = 1). Airway events were treated successfully with
jaw thrust, placement of an oral airway, or positive pressure ventilation
in all cases. One patient with laryngospasm required the placement of a peripheral
intravenous tube for intravenous medication, but no patients in the prospectively
studied group required intubation. One patient developed premature ventricular
complexes that resolved with discontinuation of halothane use. Halothane has
been reported to cause cardiac dysrhythmias in up to 34% of children younger
than 14 years,4 but there were no cases of
malignant arrhythmias or cardiac events documented during the study period.
This study found no statistically significant association between the
ASA status and the occurrence of an adverse event, which contrasts with the
finding that the existence of a concurrent medical condition was associated
with occurrence of an adverse event. Although the ASA status does not directly
measure the patient's anesthetic risk, it should relate closely to an associated
illness. The assignment of the ASA physical status is contingent on individual
subjectivity by the anesthesia provider as used in practice without external
intervention. Although the authors corrected grossly obvious errors in classification,
the subjective nature of the classification system still leaves room for a
lack of statistical correlation between the ASA status and the occurrence
of an adverse event. The discrepancy is most likely due to failure of the
system to classify correctly and consistently an illness to the proper ASA
status.
The most significant predictor of an adverse event during BMTT was the
presence of a preexisting medical illness or concurrent acute illness. Otherwise
healthy children with a history of recurrent acute otitis media or chronic
otitis media have only a 9% probability of experiencing any adverse event.
The results of the study support the intuition that a patient with pulmonary
disease has a higher probability of experiencing airway obstruction, a patient
with GERD would be more likely to have emesis, and a patient with a URI is
more likely to experience laryngospasm than a patient with no comorbid factors.
Tait and Knight5 found that the prevalence
of perioperative complications in children with URIs was similar to that in
children without URIs. Markowitz-Spence et al1
noted that 4 of 7 patients with severe airway obstruction requiring medication
intravenously and/or intubation had a URI at the time of surgery. They concluded
that when a URI is present with other chronic medical problems, the anesthesia
risk might be higher. This study similarly demonstrates a higher probability
of an adverse event occurring in a patient with a URI (P = .25) compared with a healthy patient with no comorbid factors (P = .09). However, there were no serious complications
that resulted in significant morbidity, and such adverse events that do occur
can be managed expectantly with good success. We concur that in an otherwise
healthy child the presence of a URI is not a reason to abandon BMTT.5
At the time that the study was conducted, sevoflurane was not available
for use in this tertiary care children's hospital because of its high cost.
Halothane, with its well-known effects, was the anesthetic of choice. Halothane
has been in widespread use for the past 40 years, has a proven clinical track
record, remains the least costly of the inhalation agents, and possesses the
highest potency.6 Disadvantages of halothane
include its pungent odor, tendency for a prolonged emergence,6
and potential for induction of bradycardia, hypotension, and ventricular ectopy.7 The adverse events directly attributable to halothane,
prolonged recovery in particular, could be better defined with a comparable
study using sevoflurane as the anesthetic agent.
Sevoflurane, on the other hand, is not without its disadvantages. There
is increasing concern about sevoflurane's relationship to postoperative agitation
and behavioral changes that may last for days.8
There is an increase in the incidence of agitation and excitement during emergence
from sevoflurane, almost 3-fold greater than the incidence after halothane
anesthesia,9 which is noted in 67% of children.10
Given the well-established efficacy of ibuprofen in treating mild pain,
we thought that the use of this medication in the study was warranted to provide
analgesia for postoperative pain. Ibuprofen was chosen as the medication most
likely to be efficacious with the fewest adverse effects, including lack of
behavioral changes. Although anxiolytics such as midazolam are routinely used
in some centers to decrease perioperative anxiety, we prefer to avoid the
routine administration of these medications in all patients. Midazolam is
well known to increase the incidence of dysphoria in the recovery room, which
may increase the incidence of recorded events that could be directly attributable
to the medication and mask the true results of the study. Additionally, patients
receiving oral midazolam premedication (prior to returning to the operating
room) have significantly longer recovery times.10
We acknowledge that the use of preoperative ibuprofen may falsely lower the
recorded incidence of postoperative agitation that could be attributable to
pain.
AUTHOR INFORMATION
Accepted for publication February 26, 2002.
Presented as a poster at the Combined Otolaryngology Spring Meeting
of the American Society for Pediatric Otolaryngology, Orlando, Fla, May 16,
2000.
Corresponding author and reprints: Craig S. Derkay, MD, Department
of Otolaryngology, 825 Fairfax Ave, Suite 510, Norfolk, VA 23507 (e-mail: derkaycs{at}chkd.com).
From the Department of Otolaryngology, Eastern Virginia Medical School
(Drs Hoffmann and Derkay), and Departments of Pediatric Anesthesiology (Dr
Thompson) and Clinical Outcomes, Research, and Epidemiology (Ms Burke), Children's
Hospital of the King's Daughters, Norfolk, Va.
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