General anesthesia risk across pediatric surgical specialties: Low in otolaryngology

General anesthesia risk across pediatric surgical specialties: Low in otolaryngology

Journal Pre-proof General Anesthesia Risk across Pediatric Surgical Specialties: Low in Otolaryngology Caroline M. Kolb, Dee Tinley-Strong, Rajiv Rang...

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Journal Pre-proof General Anesthesia Risk across Pediatric Surgical Specialties: Low in Otolaryngology Caroline M. Kolb, Dee Tinley-Strong, Rajiv Rangarajan, Tetsu Uejima, Udayan Shah PII:

S0165-5876(19)30533-6

DOI:

https://doi.org/10.1016/j.ijporl.2019.109780

Reference:

PEDOT 109780

To appear in:

International Journal of Pediatric Otorhinolaryngology

Received Date: 8 July 2019 Revised Date:

11 November 2019

Accepted Date: 12 November 2019

Please cite this article as: C.M. Kolb, D. Tinley-Strong, R. Rangarajan, T. Uejima, U. Shah, General Anesthesia Risk across Pediatric Surgical Specialties: Low in Otolaryngology, International Journal of Pediatric Otorhinolaryngology, https://doi.org/10.1016/j.ijporl.2019.109780. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Elsevier B.V. All rights reserved.

General Anesthesia Risk across Pediatric Surgical Specialties: Low in Otolaryngology

Caroline M. Kolba, Dee Tinley-Strongb, Rajiv Rangarajanb, Tetsu Uejimac, Udayan Shahd,e,f

a

Department of Otolaryngology, Fort Belvoir Community Hospital, 9300 Dewitt Loop, Fort

Belvoir, VA, 22060, USA b

Continuous Improvement Resource Office, Nemours/Alfred I. duPont Hospital for Children,

1600 Rockland Road, Wilmington, DE, 19803, USA c

Department of Anesthesiology and Perioperative Medicine, Nemours/Alfred I. duPont Hospital

for Children, 1600 Rockland Road, Wilmington, DE, 19803, USA d

Division of Pediatric Otolaryngology, Nemours/Alfred I. duPont Hospital for Children, 1600

Rockland Road, Wilmington, DE, 19803, USA e

Department of Otolaryngology-Head & Neck Surgery, Sidney Kimmel Medical College,

Thomas Jefferson University, Philadelphia, PA, USA f

Department of Pediatrics, Sidney Kimmel Medical College, Thomas Jefferson University,

Philadelphia, PA, USA

Corresponding author: Udayan Shah, MD; [email protected] E-mail addresses: [email protected] (C. Kolb), [email protected] (D. Tinley-Strong), [email protected] (R. Rangarajan), [email protected] (T. Uejima).

General Anesthesia Risk across Pediatric Surgical Specialties: Low in Otolaryngology Abstract Purpose: To determine the relevance of the Food and Drug Administration (FDA) warning regarding general anesthesia (GA) in children under 3 years of age for procedures lasting longer than 3 hours, by surgical specialty and for otolaryngology specifically.

Methods: A one-year retrospective review was conducted at a tertiary-care medical center for all children younger than 3 years undergoing surgical procedures with durations greater than 3 hours. De-identified data related to age, surgical service, procedure types, American Society of Anesthesiologists (ASA) physical status classification, and general anesthesia time were collected and examined.

Results: During 2017, 430 of 11,757 patients (3.7%) met the age and duration of anesthesia criteria. Procedures performed by the cardiothoracic surgery service were mostly likely to result in duration of surgery greater than 3 hours (46.6%), followed by neurosurgery (12.9%), cardiology (9.3%), plastic surgery (7.1%), general surgery (6.6%), and urology (5.1%). Less than 2% of patients undergoing ophthalmology (1.9%), orthopedic surgery (1.7%), and otolaryngology (0.5%) procedures required anesthesia greater than 3 hours.

Conclusion: Less than 4% of patients younger than 3 years undergoing surgery required general anesthesia for longer than 3 hours. The theoretical risks of general anesthesia per the FDA warning are discussed and must be balanced against the known functional and

neurodevelopmental consequences of not performing critical and time-sensitive surgery on children in this age group. A strategy for addressing parental and provider concerns is discussed. Keywords: Pediatric surgery, FDA, Anesthesia, Neurodevelopment

1. Introduction On December 14, 2016, the U.S. Food and Drug Administration (FDA) issued a warning that general anesthesia (GA) and sedation drugs routinely used for surgical procedures in children younger than 3 years or in pregnant women during their third trimester “may affect the development of children’s brains” [1]. On April 27, 2017, the FDA approved the previously announced label changes and cited animal studies showing that exposure to these drugs for more than 3 hours can cause “widespread loss of nerve cells” resulting in “long-term negative effects” on the behavior and learning of animals [2]. As a result of the FDA warnings, hospitals across the country began to implement policies to address these concerns. Texas Children’s Hospital estimates that approximately 1300 children younger than 3 years undergo procedures requiring anesthesia for greater than 3 hours, and this hospital has adopted a policy mandating a discussion with parents regarding the FDA warning prior to surgery. This discussion occurs among parents, surgeons, and anesthesiologists to address the planned duration of anesthesia, any plans for multiple general anesthetic procedures, and the risks and benefits of delaying the surgery after age 3 [3]. While animal studies are concerning, most human studies are retrospective, and there is insufficient evidence to conclude that there is a definitive risk of neurocognitive deficits related to the use of GA. Three ongoing studies will attempt to address this knowledge deficit but are currently incomplete. Two of the major studies have reported preliminary data. The GAS Consortium study has found no evidence that up to 1 hour of sevoflurane anesthesia in infants increases the risk of adverse neurodevelopmental outcomes at age 2 years; however, the primary outcome is the neurodevelopmental status at age 5 years, and the study is ongoing [4]. The second major study is the Pediatric Anesthesia Neurodevelopment Assessment (PANDA) study,

which compared healthy siblings aged 8–15 years exposed to anesthesia for 20–240 minutes when they were younger than 3 years. This study found no significant difference in intelligence quotient scores later in childhood, nor were there significant findings in the secondary neurocognitive and behavioral outcomes for this group. A lack of current prospective data regarding the implications of prolonged GA on the neurodevelopment of children creates uncertainty for surgeons, anesthesiologists, pediatricians, and other medical professionals attempting to counsel parents regarding the potential risks. A recent scoping review of otolaryngology literature on this topic shows that “there is very little mention or discussion in our literature about these concerns.” [5] There is no current consensus on how best to approach this issue with caregivers. With increased awareness regarding the types of procedures that may result in prolonged anesthesia times, we may be able to improve our ability to appropriately counsel caregivers on the potential risks for their child.

2. Material and Methods We conducted a retrospective, 1-year review from January 1, 2017, to December 31, 2017, of all surgical cases performed at Nemours/Alfred I. duPont Hospital in children younger than 3 years to determine the types of pediatric surgeries most likely to result in duration of surgery greater than 3 hours. All procedures with GA time lasting greater than 3 hours were included. De-identified data related to age, sex, surgical service, procedure types, American Society of Anesthesiologists (ASA) physical status classification, and GA time were collected and examined. General anesthesia time was calculated by anesthesia start and end times. This study was deemed exempt by our institutional review board.

3. Results Four-hundred thirty pediatric patients younger than 3 years recorded in our institutional database had one or more surgical procedures lasting longer than 3 hours during the aforementioned timeframe. The age group most likely to require a GA time greater than 3 hours for all services combined was 0–6 months; this age group comprised 40.9% of the patients (Table 1). Children from 6–12 months were the next most likely group to require prolonged GA and comprised 23.7%. With each 6-month increment in age, there were progressively fewer patients requiring prolonged general anesthesia. The mean and median ages were 10.9 months and 8.2 months, respectively. Mean and median GA times were 278 minutes (4 hours, 38 minutes) and 252 minutes (4 hours, 12 minutes), respectively. The percentage of patients younger than 3 years undergoing surgical procedures greater than 3 hours relative to the total number of procedures performed for each service was calculated. For all services, only 430 of 11,757 (3.7%) of patients met the age and duration of surgery criteria. Procedures performed by the cardiothoracic surgery service were mostly likely to result in duration of surgery greater than 3 hours (46.6%), followed by neurosurgery (12.9%), cardiology (9.3%), plastic surgery (7.1%), general surgery (6.6%), urology (5.1%), ophthalmology (1.9%), orthopedic surgery (1.7%), and otolaryngology (0.5%) (Table 2).

4. Discussion The vast majority of the evidence associated with the risks of surgery focuses on potential morbidity and mortality from surgical complications. Independent of the surgery-specific risks, there is increasing awareness that anesthesia may also cause neurodevelopmental harm to pediatric patients. An FDA warning to this effect was issued in 2016. Each specialty must

balance the risks and benefits of the surgical procedure with the potential risks of not operating or performing the surgery at a later age. Our study examined the incidence of pediatric patients younger than 3 years requiring GA for greater than 3 hours to determine whether there is a certain patient population that warrants a discussion of the risks associated with prolonged anesthesia time. We found that nearly half of all cardiothoracic surgery patients could expect to undergo surgical procedures exceeding 3 hours in duration, while orthopedic surgery, otolaryngology, and ophthalmology patients had less than 2% likelihood of requiring prolonged GA. The likelihood of requiring prolonged GA was positively correlated with increased patient complexity as measured by ASA status, with a Pearson correlation coefficient of 0.69 (P<0.05) with 95% confidence interval (Figure 1). One possible explanation for the findings of increased neurocognitive deficits in patients undergoing prolonged GA is that patients with more severe systemic health problems may be at increased risk of having neurocognitive deficits irrespective of time spent under GA. In order to determine which patients may benefit from more specific preoperative counseling on the FDA warning and the potential neurotoxicity from GA, identifying the incidence of procedures lasting greater than 3 hours for each surgical specialty is critical. Additionally, determining factors associated with longer operative times is important when patients may also be at increased risk of neurodevelopmental complications. Revision surgery and multiple simultaneous or concurrent surgeries are potential risk factors for prolonged GA time, but they may also be necessary or beneficial in reducing exposure to multiple general anesthetic events, as well as reducing health care costs and burden [6]. We discuss the incidences, procedures, associated risk factors, and other surgical specialty-related associations below.

4.1. Surgical Specialties with Higher Risk of Prolonged Anesthesia: Cardiothoracic, Cardiology, Neurosurgery, General and Plastic Surgery A key factor in analyzing the neurodevelopmental outcomes in patients undergoing surgeries associated with prolonged GA times is the prevalence of comorbid conditions that may also cause poor neurodevelopmental outcomes. While prolonged cardiopulmonary arrest time and cardiac bypass are risk factors for brain injury in congenital heart disease [7,8], preoperative assessments of newborns with congenital heart disease show preexisting neurologic dysfunction in more than half of infants [9], thus complicating an analysis of the effect of GA on neurodevelopmental outcomes in Cardiology and Cardiothoracic Surgery patients. Many patients undergoing neurosurgery have comorbid conditions or may have already suffered from insults that can result in poor neurodevelopmental outcomes. Texas Children’s Hospital analyzed the impact of comorbidities on pediatric neurosurgical patients and found that nearly half of their patient population had neurologic comorbidities, with the top ICD-9 codes including mental retardation, CNS degeneration and disease, muscular dystrophy, epilepsy, and pervasive developmental disorders [10]. These conditions may also affect neurodevelopmental outcomes independent of surgery as serve as a confounding factor. A study of neonatal patients younger than 12 months undergoing esophagogastric fundoplasty found a significant incidence of underlying disease, including congenital heart disease (54.5%), prematurity (45.5%), neurologic disease (18.2%), and respiratory disease such as laryngomalacia or subglottic stenosis (18.2%) [11]. This important point highlights the fact that many pediatric general surgery patients requiring prolonged GA have one or more comorbid conditions that may be associated with neurodevelopmental disorders.

Surgical timing is often a key factor in the decision to operate on a young child. The most important period for speech development commences soon after birth as prelinguistic functions are learned as early as the second month of life. These functions may be learned incorrectly in patients with unrepaired cleft palates and may result in compensatory articulations that could be impossible to eliminate even with aggressive speech therapy [12,13]. In these patients, it is important for caregivers to understand the potential benefits of early surgery compared with the risk of neurotoxicity from GA.

4.2 Surgical Specialties with Lower Risk of Prolonged Anesthesia: Urology, Ophthalmology, and Orthopedic Surgery While the lower risk specialties have less associated comorbidities, many conditions require expedient surgery. Urologic procedures are generally not safe to delay due to the potential morbidity including problems urinating, decreased fertility, testicular damage, and serious infections associated with failing to perform the indicated procedure on a specific timeline. The addition of other procedures was a significant confounder for ophthalmologic procedures as 6 of 8 patients underwent imaging procedures (MRI, ultrasound, and electroretinography) or another surgical procedure (gastrostomy) in addition to an ophthalmologic procedure. Overall, the likelihood of prolonged GA in strictly ophthalmologic procedures is very low. Orthopedic surgery patients are generally excellent candidates for regional anesthesia, with an average ASA of 1.9 in this study. In young children, orthopedic procedures will often require significant sedation or GA to facilitate patient compliance during the procedure. There is

also a concern for “doubling” anesthetic exposure: combining regional anesthesia with general or monitored anesthesia care (MAC). Kuo et al [14] reviewed the use of regional anesthesia in children undergoing orthopedic surgery using the Centers for Disease Control and Prevention’s National Survey of Ambulatory Surgery database. They found that only 0.6% of children aged 1–4 years undergoing orthopedic procedures used a peripheral nerve block with or without either GA or MAC, which shows that this practice is extremely rare. Further studies would be needed to assess the feasibility of regional anesthesia in young children requiring orthopedic procedures.

4.3 Otolaryngology: Lowest Risk of Prolonged Anesthesia Otolaryngology performed the highest volume of surgical cases in this age group with the lowest rate of prolonged GA (0.5%). Tympanostomy tube insertion, tonsillectomy, and adenoidectomy account for the vast majority of pediatric surgeries in otolaryngology and generally expose the patient to less than 45 minutes under GA. While the duration of otolaryngologic procedures tends to be brief in children under 3 years of age, a 2018 study showed a 13% risk of otherwise healthy children having additional surgery after tympanostomy tube insertion with otolaryngologic procedures accounting for 77.8% of second procedures. While there is conflicting evidence regarding the safety of multiple, brief anesthetic exposures, families can be counseled that the risk of second surgeries are low [15]. In our review, patients undergoing GA for otologic procedures including cochlear implantation and tympanomastoidectomy surgeries were at higher risk of prolonged GA time. Overall, the otolaryngology service performed the most surgical procedures (4,138 patients) and had a low percentage of patients younger than 3 years requiring prolonged GA (0.5%). While the likelihood of requiring prolonged GA in this demographic was low in otolaryngology, a recent

epidemiologic study indicates that the most common “first procedure” children receive is otorhinolaryngologic (44.9%) and frequently occurred in the first year of life (39%) in this cohort [16]. In young children with severe to profound bilateral sensorineural hearing loss, early cochlear implantation has been shown to improve sound detection, auditory perception skills, speech production, speech recognition, and speech intelligibility [17-20]. Research also demonstrates that children implanted at a younger age tend to perform better in most measurable tests of speech and language development [21]. Bilateral cochlear implantation offers significant benefits due to the head shadow effect, sound localization, and loudness summation. Most agree that bilateral stimulation should occur during a critical window of development to optimize auditory functioning [22]. However, with new evidence regarding the potential risks of prolonged GA, there is some question regarding whether or not the benefits of bilateral implantation exceed the risks associated with prolonged GA.

4.4 The Effect of Combined Procedures Another topic that has hitherto received little attention is the common practice of combining multiple procedures, imaging, and other tests requiring GA, in order to avoid multiple separate anesthesia events. In this study, many patients undergoing cleft lip and palate repairs or palatoplasty also required simultaneous tympanostomy tubes. Auditory brainstem response (ABR) testing was the second most common reason for prolonged GA among otolaryngology procedures (Table 3). Patients requiring otologic surgeries may be unable to comply with the testing conditions for behavioral audiograms and may require sedated ABR testing. The average time for ABR testing done in isolation in a child younger than 3 years is

101 minutes, which can further prolong the GA time when done in combination with other procedures. Investigators are actively exploring alternatives for GA for ABR and other diagnostic testing using chloral hydrate [23] and dexmedetomidine [24]. When the procedure is performed in conjunction with other otologic procedures, it may be possible and preferable to convert to one of these agents for the ABR testing. Strategies like this may decrease the duration of GA and should be investigated for each type of procedure requiring GA. As the utility of ABR is questionable when performed in conjunction with GA [25], prolonged GA may provide additional reasons to separate the two procedures.

4.5 Caregiver Counseling Our review can help providers identify “at-risk” populations. There is significant debate among providers regarding who is the best specialist to have that conversation. Pediatricians and family medicine providers usually know the patient best due to an enduring patient-parentprovider relationship. Anesthesia providers generally formulate the anesthetic plan and may understand the special risks of using each type of anesthetic agent in the proposed surgical procedure. Surgeons understand the indications for surgery and can best predict the duration of the surgery, as well as the level of anesthesia related to each portion of the proposed surgical procedure. Informing all levels of providers regarding the potential risks is essential since parents and guardians may direct their questions and concerns at anyone throughout the process. Ultimately, it is prudent for both the surgeon and anesthesia provider to generate an anesthetic plan that addresses surgical duration, level of anesthesia required throughout the procedure, and

ways to mitigate the duration of exposure to GA. This information should be conveyed to the caregiver in any method deemed appropriate by the providers or the institution.

4.6 Decreasing Risks to Young Children Methods to mitigate the neurocognitive risks of anesthesia by decreasing exposure time should be explored further. Some potential methods to decrease anesthesia duration:

1.

Using regional and/or local anesthetic when possible

2.

Ensuring all equipment is in the room prior to patient arrival to the operating room

3.

Decreasing the preparation and set-up time while the patient is under GA

4.

Performing diagnostic procedures in a clinical setting when possible

5.

Defining the roles of each team member in the operating room and increasing operating team communication prior to and during anesthesia

6.

Using advanced medical technology when it significantly shortens GA time; abandoning unnecessary medical technology that does not improve the safety or efficacy of the procedure

7.

Identifying anesthesia providers and surgeons who deviate from the norm to learn from “faster” providers and improve efficiency in “slower providers”

5. Conclusion The application of the FDA warning likely applies to a very small proportion of pediatric patients undergoing surgery across the United States. In this study, less than 4% of children younger than 3 years at a tertiary care medical center underwent surgery requiring general

anesthesia for longer than 3 hours. The FDA selected the 3-hour cutoff based on comparisons to animal studies showing that general anesthesia for more than 3 hours caused widespread loss of nerve cells in the brains of fetuses and young animals [1]. At present, there is no evidence to demonstrate a correlation of animal studies to humans with respect to the 3-hour demarcation. Cardiothoracic, neurosurgery, plastic surgery, and cardiology procedures have a greater than 7% risk of requiring GA times greater than 3 hours. Future prospective studies evaluating the effects of GA in patients without comorbid conditions are needed but may be difficult to obtain. Otolaryngology procedures have a very low incidence of requiring prolonged anesthesia. Performing ABR procedures under the same general anesthetic may reduce the number of exposures to GA but can prolong anesthesia beyond the 3-hour mark. The theoretical risks of GA must be balanced against the known functional and neurodevelopmental consequences of not performing critical and time-sensitive surgery on children in this age group. A strategy for addressing parental and provider concerns regarding GA is critical for primary care providers, surgeons, and anesthesia providers. A model of shared decision-making can be useful for properly informing caregivers of pediatric patients considering procedures requiring GA. This model strives to achieve an equal partnership between providers and caregivers in making decisions for pediatric patients. Informing caregivers of the FDA warning regarding repeated exposures and the duration of exposure may be more important when performing procedures typically lasting longer than 3 hours or for patients with previous GA experiences. Addressing concerns regarding the types of anesthetics, surgical timing, relative necessity of the procedure, and the possible need for other procedures in the near future may assist parents during the informed consent process.

Conflicts of Interest None of the authors have competing interests to declare. Acknowledgement The authors appreciate the editorial review and guidance of Ellen Spurrier, MD. Funding None

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[16]

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Figure Legends Figure 1. Percentage of Surgical Case Volume > 3 hours and < 3 years vs Average ASA. Pearson Coefficient was calculated as 0.69.

Table 1. Demographic Data (Age Group in Months vs Surgical Service) Age in Months Grand Surgical Service

0-6

6-12

12-18

18-24

24-30

30-36 Total

Anesthesiology

0

1

0

0

0

0

1

Cardiology

8

8

3

3

6

0

28

Cardiothoracic

74

14

4

5

3

4

104

Dentistry

0

0

0

0

1

1

2

Gastroenterology

0

0

0

0

0

1

1

General Surgery

58

17

7

3

5

3

93

Neurosurgery

10

5

4

8

4

0

31

Ophthalmology

4

1

0

1

2

0

8

Orthopedic Surgery

2

10

5

4

6

4

31

Otolaryngology

3

3

4

5

2

2

19

Plastic Surgery

7

11

10

3

1

3

35

Pulmonology

0

0

0

1

0

0

1

Transplant Surgery

0

1

2

1

0

1

5

Urology

10

31

9

8

9

4

71

40.9%

23.7%

11.2%

9.8%

9.1%

5.3%

Total Percentage

Table 2. Percentage of Surgical Case Volume Lasting Greater Than 3 Hours by Surgical Service # of

% surgical

Average

patients

case volume

ASA (1-5)

Most Common Procedures

Surgical Service

Cardiology

28

9.3%

3.8

Combined right and retrograde left heart catheterization for congenital cardiac anomalies with or without interventions to open stenotic vessels or close abnormal cardiac openings

Cardiothoracic Surgery

104

46.6%

3.9

Complete atrioventricular canal repair, pulmonary artery stenosis repair, tetralogy of Fallot repair, transposition of great arteries repair, repair of hypoplastic aortic arch, atrial and ventricular septal defect repair

General Surgery

93

6.6%

2.9

Enterostomy closures, celiotomies, diaphragmatic hernia repair, and esophagogastric fundoplasty

Neurosurgery

31

12.9%

2.8

Craniotomy with partial or subtotal hemispherectomy, lobectomy with electrocorticography, laminectomy with release of tethered spinal cord, and revision or replacements of an obstructed cerebrospinal fluid shunt

Ophthalmology

8

1.9%

2.4

Inferior oblique myectomy, recession of lateral rectus, blepharoptosis repair, and ab externo trabeculotomy

Orthopedic Surgery

31

1.7%

1.9

Elbow arthrotomy with capsular excision or release, polydactyly and syndactyly procedures

Otolaryngology

19

0.5%

2.5

See Table 3

Plastic Surgery

35

7.1%

2.2

Cleft palate repair, palatoplasty

Urology

71

5.1%

1.7

Hypospadias repair, pyeloplasty with or without ureteroneocystostomy, and inguinal orchiopexy repair

Table 3. Otolaryngology Procedures Lasting Greater Than 3 Hours # of Patients 6

Procedures Bilateral cochlear implant with muscle flap with or without telemetry Auditory brainstem response testing with bilateral ear tube placement +/-

5 other procedures of short duration 4

Multiple combined procedures with other services

1

Right cochlear implant with muscle flap with telemetry

1

Excision of tracheal stenosis and anastomosis with bronchoscopy

1

Left tympanoplasty and exam under anesthesia of the mouth Excision of right tongue lesion with direct laryngoscopy and

1 bronchoscopy