Ethical Considerations of Unsedated Esophagogastroduodenoscopy in Pediatric Patients

Abstract

A 10 year-old child requires an esophagogastroduodenoscopy (EGD). One of the child’s parents is requesting an unsedated esophagogastroduodenoscopy, citing their experiences in a different country and concerns about anesthetic medications. The child is assenting to the procedure. The patient previously had multiple sedated EGDs without complications. Concerns are raised by the anesthesia, GI, and operating room teams about the ethics and child safety of performing an unsedated EGD, given this is not the typical standard of care at the performing hospital. In this paper we analyze prior literature and ethical principles, and explore whether unsedated EGD with appropriate monitoring is an ethically acceptable alternative to sedated EGD in this instance.

Conflicts of Interest. The authors have no conflicts of interest to disclose.

Introduction

Parental refusal of sedation for a procedure in which sedation is the standard of care raises several difficult ethical questions for the pediatric anesthesiologist. Since there are ethical differences between refusal of treatment in pediatric and adult medicine, it may not be clear to practicing providers how to respond to an ethically challenging situation such as this. In this paper, we raise ethical considerations regarding parental refusal of sedation, review literature and standard of care for comparable situations, assess the medical safety of unsedated EGD, and offer recommendations for pediatric anesthesia providers encountering similar scenarios.

Case Presentation

A 10-year-old patient presented for routine follow-up endoscopy for eosinophilic esophagitis. This patient had already had several endoscopies at this location, all with anesthesia. However, one of the patient’s parents had noted their discomfort with several medications used by the anesthesia care team in the past, and had frequently negotiated which medications should and should not be used in the patient’s care.

At age 9, the patient required another endoscopy, and the parent requested no sedation, noting that in the parent’s home country, endoscopies without sedation are routinely done for adults. After discussion about the standard of care at the performing hospital and the child’s maturity, the family agreed to an anesthetized EGD. A few months later, the patient required another EGD while their family was in the parent’s home country. At that time, the patient received an unsedated EGD and then returned to the United States. For the patient’s next endoscopy, the parent again requested an unsedated EGD, this time bringing literature on unsedated pediatric EGDs to support the practice. The parent assured the care team that the previous unsedated EGD went well with no complications and was well tolerated by the patient.

Given that the patient’s last endoscopy had been unsedated, the parent strongly requested an unsedated EGD be performed. The child assented to the unsedated procedure; however, care team members noted some instances in which the parent would speak to the patient in the parent’s native language immediately prior to the patient answering questions, despite all other communication between them being in English. This observation raised some concerns for coercive behavior wherein the patient preferred a sedated EGD but was being instructed to say otherwise. To aid in decision-making, the care team searched for a relevant hospital policy but found none. Concerns raised by the care team included the potential for laryngospasm, vomiting/aspiration, or intolerance of the procedure requiring premature cessation or incomplete examination. Psychological harm was of particular concern to the team, as the ramifications of a patient being forced to acquiesce to a potentially traumatic procedure against their will could be severe. After multidisciplinary discussion between anesthesia, gastroenterology, and child life, a decision was made to schedule the case as a non-sedation endoscopy with anesthesia present for monitoring and conversion to general anesthesia if needed. The care team also negotiated with the parent to ensure that a child life specialist would be present to assess and ensure the child’s psychological safety and support the child through the procedure.

The provider leadership intentionally chose physician, nursing, and technical staff with experience in this procedure as well as in challenging situations, due to their preparedness to help the patient through the procedure. The plan for the procedure was discussed thoroughly with all participants prior to the patient’s arrival to allow optimal care. The patient’s airway was treated with aerosolized lidocaine and an IV was placed in case of emergency or a need to convert to general anesthesia. Throughout the procedure, both the child life specialist and the anesthesiologist were present and remained engaged with the patient to keep the patient distracted. At the conclusion of the procedure, the patient did begin to show some signs of anxiety, including diaphoresis, increased squeezing of the anesthesiologist’s hand, and an increased heart rate. Fortunately, the procedure was nearly finished by this point, and the EGD was completed with no adverse events noted.

Ethical Considerations

This case raises several ethical questions that warrant further consideration. Is it acceptable for this procedure, which is usually performed with anesthesia in pediatric patients in the United States, to be performed unsedated? Is it ethically acceptable to deviate from the standard of care in a pediatric patient upon parental request? What role should child assent play, particularly if the team is concerned about parental coercion? How can the child’s best interest be evaluated? If the anesthesia and gastroenterology teams decide to proceed, what is the best way to avoid harming the patient?

The limits of parental decision-making

In previous literature regarding pediatric anesthesia and the issues of consent, parental decision making and consent receive more focus than patient assent or understanding. A review by Feinstein et al. (2018) regarding informed consent in pediatric anesthesia found that only 2 out of 22 papers pertained to patient understanding and/or refusal, whereas 12 papers were dedicated to parental understanding and preferences. Given this imbalance, it is clearly important to consider the input of the parents, although this review also points to a dearth of literature regarding pediatric assent. Furthermore, since parents are generally more knowledgeable about a child’s state of health than either their healthcare providers or the child, the parents are uniquely well placed to evaluate both what the child wants right now, as well as what will best serve the child’s long-term interests (Diekema, 2004).

The involvement of multiple stakeholders and the frequent lack of decision-making capacity in pediatric care can make the application of biomedical ethics less clear than in adult medicine. Given the nature of autonomy in adult patients, unsedated EGD in decisional adults is uncontroversial (Bishop et al., 2002). However, for a pediatric patient, autonomy is more difficult to define. In the past, paternalism in medicine meant that often even adult patients did not have true autonomy or informed consent. While the shift to autonomy for adult patients is broadly viewed as good, for children the shift has been not towards true autonomy; rather, as a shift from physician to parent as decision maker (Kon, 2006). If a parent makes a decision that we as healthcare providers do not view as within the best interest of the child, how should we respond?

Although parental consent is paramount, there may be times when a care team believes a parent is making a decision that may harm the child or be otherwise contrary to the child’s best interests. A well-known example of healthcare providers limiting parental authority is that of parents refusing lifesaving blood transfusions for their children due to religious beliefs. Prince v Massachusetts (1944) established the precedent that while parents may freely make sacrifices for their own beliefs, they cannot do so at the expense of their children’s well-being (Linnard-Palmer & Kools, 2004). Put simply, parents are permitted to refuse a life-saving intervention for their own treatment if it conflicts with their beliefs, but they are not permitted to refuse that same intervention for their child.

However, most cases involving dissent between caregivers and healthcare providers are not so cutand-dry, and there is substantial room for debate. For example, in cases of scoliosis where foregoing surgery is clearly harmful but there is no immediate emergency, courts are less consistent in overriding parental refusal of blood transfusions (Truog & Rockoff, 1991). Diekema (2004) proposed the harm principle as a means of systematically evaluating situations of this nature. He argues that state intervention may be justified if a parent or guardian decision poses a significant risk of serious harm to the child. The harm threshold, assessed by criteria such as the imminence of harm and the necessity of intervention to prevent serious harm, may offer a more helpful guide for intervention than the frequently employed best interest standard.

Furthermore, Kon et al. (2006) note that health-care providers can sometimes think of their own viewpoints as ethically sound and dismiss parental viewpoints out of hand, even if these parental viewpoints are not inherently unreasonable. Therefore, it is very important to consider a broad set of cultural, religious, and ethical backgrounds when synthesizing frameworks and decisions around such issues. These last two points are particularly salient in cases such as an unsedated EGD, where it is not clear whether foregoing sedation would necessarily be harmful, as discussed in the next section. In non-life-threatening situations like this, it is more reasonable to grant some deference to parental authority than in cases requiring life-saving interventions, such as blood transfusions.

Similarly, consider the case of parental refusal of opioids. In a recent review, Moreno-Galvan et al. (2021) lay out a practical approach for considering refusals, including strategies such as inquiring about parental understanding and reason for refusal, further educating the parents on risks and benefits of opioid treatment, and consideration of alternative strategies for pain management. The authors conclude that there are many situations in which parental refusal of opioids should be respected, even if doing so is clinically sub-optimal, so long as it does not cause serious harm. In at least some cases it can be appropriate to defer to parental wishes even if those wishes are not fully concordant with the standard of care. We now consider whether unsedated EGD should be an accepted practice and how much, if at all, it deviates from the standard of care.

The medical acceptability of unsedated EGD: evaluating “standard of care”

While evaluating the medical efficacy of an unsedated EGD is outside the scope of this paper, prior literature and ethical principles help ascertain its potential acceptability. In adults, unsedated EGD is more routine than in children and has been better studied. According to Bishop et al. (2002), the majority of adults who undergo unsedated EGD would be willing to undergo another unsedated EGD. In addition, they note that in adult patients in some countries, unsedated EGDs are more common than sedated EGDs.

EGDs are also becoming more common in children in recent years, and while the safety profile is overall good for sedated pediatric EGDs, transient hypoxia and cardiac complications have been noted. Bishop et al. evaluated pediatric unsedated EGD over a period of 3 years and found that with proper screening of candidate children, it could be acceptable. The majority of children in this study received general anesthesia or procedural sedation, with some children being put into a candidate group and opting either for sedation or no sedation. The no sedation group had lower pre-EGD anxiety scores and were older on average (age 13.5), but otherwise the groups were largely similar. Overall in the Bishop et al. study, outcomes were good, with 78% of children in the unsedated EGD group saying they would undergo another unsedated EGD, and procedure completion rates were similar.

In the case of unsedated EGD, potential harms include higher anxiety, the possibility of a requirement to convert to a general anesthetic, lower quality of endoscopic exam, emesis and aspiration, and long-term psychiatric harm due to severe pain. The clearest benefits are lower cost, less time spent in the endoscopy suite, and faster recovery time. An additional possible benefit of unsedated EGD to consider is that anesthetic medications themselves are not without risk. Short-term risks such as the aforementioned hypoxia and cardiac complications, as well as more minor side effects such as nausea and vomiting and allergic reaction, are well-studied and their avoidance is a benefit of an unsedated EGD. Conversely, data are limited on long-term effects of anesthesia in children, but it is possible that repeated exposure to such medications could have prolonged detrimental effects on the developing nervous system (Culley & Avram, 2018). While the risk would be highest in neonates, it is important to note that we cannot rule out long-term effects on older children or teenagers.

It is worth noting that in the study by Bishop et al., 40% of children in the candidate group chose to undergo unsedated EGD without direct parental input (although it is possible there was some indirect parental influence on their children’s beliefs). Given the results of the study, and particularly the fact that pain and anxiety scores were not increased, in appropriately selected child candidates there is very low risk of a lack of sedation causing increased anxiety, pain, or long-term psychiatric harm related to pain. Further, even in much more invasive procedures such as awake brain surgery, psychiatric harm appears to be uncommon when performed in appropriate candidate patients (Huguet et al., 2019). Meanwhile, some pediatric patients will experience long-term psychiatric trauma from far less invasive procedures such as peripheral IV placement (Getchell et al., 2022), and these patients and their families would be very unlikely to request an unsedated EGD. While there is not enough existing data to completely rule out the possibility of psychiatric harm in unsedated EGD, it is clear that the probability of psychiatric adverse events is low enough that it should not serve as a contradiction to the procedure–especially since anesthesia itself also carries some risks for psychiatric harm. Thus, while there are many patients for whom an unsedated EGD would not be a viable option, an unsedated EGD may be an acceptable alternative to a sedated EGD in certain assenting children.

The role of pediatric assent

While children are often assumed to be incapable of true informed consent, this is not always the case for older children, particularly teenagers, as pediatric assent often carries more weight as children age. In a study carried out by Feinstein et al. (2018), 12 was the median minimum age at which anesthesiologists would respect a child’s independent refusal to go forward with anesthesia.

Generally, cases where a pediatric patient’s wishes differ from that of their parents are evaluated on a case-by-case basis. In cases where children wish to forego or defer anesthesia and operative treatment, many factors such as the rationality of the child’s concerns, expected pain levels, the level of necessity of the treatment, and the age and state of mind of the child combine to inform the ethical outlook; age is certainly not the only factor (Walker, 2009). Walker provides the following examples: a 13-year-old child might not be allowed to refuse anesthesia if he is suffering from emergent appendicitis which requires a prompt appendectomy, but a 9-year-old child might be granted that choice if her parents are attempting to force her to acquiesce to a plastic surgery that is neither urgent nor medically necessary, regardless of whether the harm threshold is definitively met. While these examples are operative, the same principles can be extended to the presence or absence of sedation. All pediatric patients have a right to their views and concerns, and if the basic interests of the patient are not immediately threatened, then the patient’s emerging autonomy, although limited in the aforementioned sense, should be respected to the greatest extent possible. Because a capacitated adult’s autonomous choice is generally respected (if the choice is medically feasible), there are certain cases where a capacitated adult can refuse a procedure whereas a child may not. But in the case of a routine scheduled EGD for this particular patient, ethical principles dictate that the child’s wishes warrant consideration.

The majority of prior literature on such topics deals with cases of refusal of anesthesia and the concomitant procedure, whereas in this case anesthesia alone was not used, and this was the stated preference of both parent and patient. General principles derived from similar cases and ethical considerations are broadly applicable and suggest the child’s input ought to be considered.

Table 1.

Some Types of Coercion

Assessing the possibility of coercion

One feature of this case that warrants further discussion is the possibility of coercion. Often, a parent will want a child to undergo anesthesia and the child will not want to, or there will be some other way in which the desires of the parent and child are not wholly concordant. In this case, the desires of parent and child are superficially concordant, but it is difficult to rule out coercion, or even to define it. For the purposes of this section, coercion is defined as the use of threats, direct or indirect, to persuade someone to do something they would otherwise not do. If the parent tells the child behind closed doors or in another language that they must accept what they say, this definition of coercion is clearly present. But, what if the child is indirectly influenced? In this case, perhaps the child’s cultural upbringing has led them to believe that asking for sedation would be viewed as dishonorable or weak. Is this coercion, wherein a child is forced to acquiesce to values we perceive as unreasonable, or simply a valid cultural viewpoint that is different from that of the healthcare provider? Additionally, given that care team members were concerned with the tone of communication between parent and child in the parent’s native language, how can we evaluate for direct coercion?

A full answer to the question of culture and indirect coercion is beyond the scope of this paper, but we can explore how this concept applies in this case. It is widely agreed within medical ethics that there are at least some cases where the parents’ cultural or religious desires, even if shared by the child, are less important than the child’s life, such as in the case of a toddler requiring a blood transfusion. However, for older children, even life and death cases can lead to controversy. The now-famous case of Dennis Lindberg serves as an excellent example. Dennis Lindberg was a 14-year-old boy who was permitted to refuse a transfusion on the grounds of his religious beliefs. His legal guardian was a Jehovah’s Witness, and Lindberg had recently converted to that faith. After much controversy the child was permitted to refuse the transfusion and did not survive (Coleman & Rosoff, 2021). However, more recently in Canada, a 14-year-old child was not permitted to refuse a transfusion, despite similar circumstances (“Jehovah’s Witness, 14, ordered,” 2017). In older children, one could argue that religious or other cultural values have become authentic to the child’s own identity, as with the case of Dennis Lindberg, whereas some individuals may view religious influence from parents or guardians as indirect (and possibly harmful) coercion. Situations such as this require case-by-case analysis, wherein a child’s expressed cultural values are weighed against the consequences ensuant from their decisions.

Ethical guidance alone cannot quantify or identify indirect coercion, and there is room for disagreement in such cases. However, the above cases are matters of life and death, whereas for an unsedated EGD the potential negative impacts from deviating from the standard of care are minimal in comparison (Bishop et al., 2002). Given this distinction, the question becomes both less consequential and easier to answer for this specific case. When two alternatives have a similar safety and outcomes profile, it is not unreasonable or unusual for cultural preferences to be respected. In this way, clinicians can practice cultural humility that both supports the patient and family and upholds tenets of sound clinical care.

Moreover, once one starts looking for indirect “coercion by culture,” it is omnipresent. For example, if a male child does not want a vaccination and starts crying, but assents because his parent once told him that male children don’t cry, indirect cultural coercion has occurred. While many people might disagree with that parenting philosophy, very few of them will advocate stripping the parent of decisional authority for the child. When a parent “nudges” their child into a course of treatment, if there is not a significant outcome difference, then it is generally acceptable in most cases (Linnard-Palmer & Kools, 2005). Indirect cultural coercion is thus unavoidable and does not constitute a reason to avoid performing an unsedated EGD on a child who assents.

The case of more direct coercion is also pertinent. As mentioned previously, a child is permitted to refuse a medically unnecessary operation in certain cases (Walker, 2009). In this case with no sedation contraindications, if the pediatric patient would strongly prefer a sedated EGD and is being forced by the parent to assent to an unsedated EGD, then it would be reasonable to refuse to perform the unsedated EGD, since the parent’s request for no sedation is medically unnecessary. This raises the question of how to assess whether direct coercion is happening, behind closed doors or in front of the care team in another language. Unfortunately, as the healthcare team is not privy to the entirety of the parent/child relationship, such coercion can never be ruled out completely. However, if there is reason to suspect coercion is occurring, it would be appropriate to seek counsel from a hospital ethics team, child life services, or child protective teams.

Potential actions for the medical team

While anesthesiologists have a duty to maximize a patient’s welfare and avoid doing harm, healthcare providers often become invested in minor differences in outcomes such that they develop blind spots for acceptable alternatives (Kon, 2006). Consultation of a hospital ethics team can be valuable in such situations, as an ethics team is more likely to consider all viable alternatives. In cases where a treatment can keep a patient alive but with a subjectively low quality of life, the parents might feel that the patient’s suffering outweighs the benefit of continued life, and an ethics team is better placed to evaluate whether there is merit to this claim, as opposed to the primary care team who might be biased in favor of continuing life regardless. Kon notes that in some cases, a guardian ad litem can be appointed. Overall, in such cases, it is more appropriate to consult an in-house ethics team first and only seek judicial review in cases where negligence or abuse is suspected. Kon argues that the majority of such ethics consults revolve around poor physician-parent communication, and that in most cases parents want the consult called. This would likely not be true for this case. Regardless, if the anesthesia care team in this case were concerned, an ethics consult would be appropriate. If there is concern of coercion, other teams with experience in child protection and/or parent-child relations could be consulted to evaluate for this possibility.

Another potential action the anesthesia care team could take is the involvement of a child life team, or any team with similar responsibilities. While minimal prior research exists on the use of child life specialists during EGD, particularly unsedated EGD, one study used child life services in combination with video goggles to aid in unsedated magnetic resonance enterography and found that it could be successfully performed (Courtier et al., 2015). Child life specialists have also been shown to reduce fear in children receiving venipuncture (Getchell et al., 2022). Therefore, it is likely that the presence of child life services would be helpful in reducing pain, anxiety, and any potential for psychological harm to the patient in the case of pediatric unsedated EGD. This would also likely be the case for sedated EGD, and it is possible that child life services are a helpful addition to any pediatric EGD regardless of sedation status. We recommend further study in this area.

Finally, transnasal EGD can be considered if available. The transnasal EGD utilizes a smaller fiberoptic scope and may be tolerated better when unsedated. There is evidence in papers by Hall et al. (2018) and Friedlander et al. (2016) that it can be indicated for children with certain conditions who require frequent EGDs. While in many cases this method will not be appropriate, the transnasal route can be considered in candidate patients, especially if the patient’s parent would prefer the EGD to be unsedated.

Conclusions

Considering this case from multiple lenses, from child welfare to child assent to parental values and consent, it is our perspective that it is ethically acceptable to attempt an unsedated EGD on this patient. However, medical practitioners should not be forced to perform a procedure if they do not feel comfortable or confident in their ability to do so successfully. While a provider should not be forced to carry out such a procedure, they should recommend a provider who might be willing to consider it (Pruski & Gamble, 2019; Stahl & Emanuel, 2017).

There are some factors in this case that might reasonably give providers pause, such as the possibility of coercion and the fear that physical or psychological harm might result. Obtaining the aid of services such as an ethics consult team and child life specialists can be valuable ways of ameliorating these issues. Based on previous literature, the safety profile of unsedated EGD when performed on appropriate patients is similar to that of sedated EGD, if not slightly better. An unsedated EGD may also add several benefits not related to risk, such as potentially lower cost and less time in the endoscopy suite.

As healthcare providers, it is important to weigh all alternatives to provide the best care for patients as individuals, rather than attempting a “one size fits all” model of medicine. In this case, it is the opinion of these authors that unsedated EGD is an ethically acceptable alternative to sedated EGD in this patient.

Discussion Questions

1. 1. How might a similar dilemma be approached if forgoing anesthesia is likely to be significantly harmful? (e.g., AVM embolization or some other procedure where movement can be devastating).

2. 2. How does the etiology of the parent’s desire for no anesthesia matter in this case?

3. 3. If the care team does not feel comfortable performing a procedure on an unsedated patient, they may refer the parent and patient to another care team. How should the care team evaluate the ethical acceptability of referral for procedures/specialties with scarce provider availability and long wait times?