To Sedate or Not: Parents Right to Informed Consent

Editorial by Janet DesGeorges and Sara Kennedy, Colorado Families for H&V

It is time to end the unnecessary sedation of infants  for diagnostic ABR (Auditory Brainstem Response testing) in the process of the  1-3-6 model in Early Hearing Detection and Intervention (EHDI) systems.  The risk of sedation in infants is well known  and should be avoided when possible. Infants who are younger than six months  are at higher risk for serious adverse events; including hypoxia, allergic  reaction, airway obstruction, and even death.   For many of us parents, concerns about sedation are dismissed with a  “it’s perfectly safe” statement. However, even a brief review of the medical  literature indicates that sedation is far from a routine, predictable,  standardized procedure. At a summit held on just this topic, this statement was  made:

“There was consensus on the panel (of differing medical  practitioners involved in sedation of babies and children) that the  state-of-the-art pediatric sedation system would include expert airway  providers using short-acting medications like Propofol with advanced monitors  and ideal environmental conditions. Most of the anesthesiologists that  regularly use these drugs did not consider the average sedation case to be  technically challenging. These observations beg the question, ‘Why is pediatric  sedation commonly provided with relatively unpredictable, low potency, long  acting drugs like oral chloral hydrate by non-airway experts in a suboptimal  monitoring environment?’” (PEDIATRICS Vol. 117 No. 3 March 2006, pp. e434-e441  (doi:10.1542/peds.2005-1445) Chloral Hydrate Sedation for Pediatric  Echocardiography: Physiologic Responses, Adverse Events, and Risk Factors)

The panelists answered this question by citing the  various barriers (economic, political, regulatory) that currently prevent us  from providing the “best possible outcomes” to children having procedures.  Across the nation, there is no standard of care established regarding if, or  when, young infants in need of a diagnostic ABR or similar test should be  sedated or not.  Depending on where a  family goes for diagnostic testing, the practice of sedation follows irregular  and undefined protocols.

One family walking through the door of an audiology  practice in a hospital in Virginia  will automatically be scheduled for a sedated ABR regardless of their baby’s  age. Another family walking through the door of an audiology practice in a  hospital in Colorado  will automatically be scheduled for a natural sleep state ABR until the age of  six months. Why the discrepancy?

The answers are complex and can be traced to both  practical and institutional responses. When parents ask the professionals in  their lives about why one infant is subject to sedation, and another isn’t,  different answers to that question emerge.

Some audiologists feel they can get better information  when the infant is sedated, though this is disputed by others. Other reasons  for sedation include the administrative convenience of scheduling in audiology  practices; the relative ‘ease’ of managing the testing while under sedation  versus sleeping due to normal behavior of babies/toddlers in natural sleep  states;  and the sedated ABR may take  less time. One financial reason we have heard but not verified is that  insurance companies will only reimburse for one ABR diagnostic visit, so  practices don’t want to take the risk of needing to schedule more than one  visit.

Based on our own stories, sleep deprived diagnostic  testing is possible. Our daughters were 14 months and 22 months old when their  testing was completed. In one case, one of us chose nonsedated testing because  of the ENT’s statement that “we used to do the testing here, but we don’t have  the resuscitation equipment now required.”   Maddie’s unsedated testing did require two visits, but was felt to be  valid.

Mavis Irwin, identified in 1982 when she was 15 months  old, was also not sedated at the request of her parents. The closest equipment  was more than five hours away. As a physician himself, Mavis’ father felt  strongly that sedation was risky and that it was mostly given for the  convenience of the clinician. Mavis’ parents spent the day dragging a very  crabby toddler around town and she fell asleep nicely at the clinic, even for  multiple kinds of testing. Dr. Jim Irwin notes that general anesthesia for ABRs  may soon be a thing of the past anyway, because there is a new device that gets  the data so quickly that there is no need for the child to be  sleeping. (i.e. Vivasonic ABR)

In the medical field, the principle of “informed  consent” guides, or should guide, medical practices. A patient (or parent) must  be fully informed in order to participate meaningfully in making choices about  health care. The principle originates from the legal and ethical right the  patient (or parent)  has to direct what  happens to his or her body, or body of a child, and from the ethical duty of  the physician to involve the patient in his or her own health care. Are parents  fully informed about the nature of sedation, and its reasonable alternatives,  such as sleep deprived testing, and the relevant risks, benefits and  uncertainties related to each choice.

For all of the parents in our story who chose to forego  sedation, the risks of sedating a child who just needed to be quiet –not  unconscious– for the procedure (however lengthy) outweighed the benefits. We  believe that every parent has the right to make an informed choice about  whether they want their infant sedated or not for the diagnostic ABR, ASSR, or  other testing. Each family must weigh the risk of sedation with the benefits  that sedated ABR may bring with the individual personality of their baby in  mind. Indeed, not all parents may be able to wake the baby hours early and  avoid feeding for some hours prior to an unsedated test to help their baby or  toddler fall asleep more deeply when finally fed and comforted to sleep in the  parent’s arms or familiar child seat at the clinic or hospital. In the world of  hearing loss and deafness, there seems to be no one “right” answer for many  things:  communication options,  educational placement decisions; technology options; genetics testing. It is  time for professionals to speak up and create quality standards and practices  regarding the use of sedation in diagnostic ABRs. The professional  organizations have been strangely silent on this practice to date.

Should parents have the right to choose sedation or not? We  think so!