n the modern era, the administration of general anesthesia to healthy children has been remarkably safe. Yet controversies and medical mysteries arise on a regular basis. The past year or two have been no exception, with articles in the literature on a variety of topics that potentially impact the safety of anesthetized or sedated children. In this article, we will briefly summarize some of the topics that are gaining the attention of pediatric anesthesiologists, including the growing practice of laparoscopy and thoracoscopy, the value of brain-function monitoring, the potential for anesthetics to cause neurotoxicity in the developing brain and a growing concern regarding the type of physicians who provide sedation for medical procedures in the hospital setting.

Endoscopic Procedures
Advances in endoscopic equipment and techniques have led to the use of minimally invasive surgery in an ever-increasing number of pediatric surgical procedures [Table 1]. Some of these procedures may be performed on premature newborns weighing less than 2 kg. As the surgical approaches have expanded, there has been a concomitant increased demand on pediatric anesthesiologists to meet the challenges these procedures present, and such challenges include new twists on old issues. No longer are distance and access the only positioning issues. Now additional equipment and personnel may be placed between the anesthesiologist and the patient, including flat-screen monitors, a surgical assistant and sometimes even a large robot!

Other issues present additional challenges. Many thoracoscopic procedures can be aided by the use of one-lung ventilation. Obtaining and maintaining endobronchial intubation in very small or very ill pediatric patients is often quite difficult. Carbon dioxide insufflation into the chest or abdomen can cause significant physiologic derangement. Concomitant CO2 absorption and hypercapnia also may occur, and just because these procedures are labeled “minimally invasive” does not mean that things cannot go seriously awry in a very short period of time.

What is the reward for meeting these new challenges? Postoperative morbidity from the surgical procedure itself is significantly diminished. How significantly? Some children may be discharged home on the same day as thoracoscopy. Nissen fundoplication patients may eat six hours after surgery and are usually discharged the next day. Pain control may be significantly improved, and postsurgical ileus is greatly diminished.

Pediatric Awareness Monitoring
Recently the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) issued a Sentinel Event Alert titled “Preventing, and Managing the Impact of, Anesthesia Awareness” <www.ASAhq.org/new/SEAfinal.pdf>. In conjunction JCAHO also issued a Media Alert, disseminated information to the media and invited representatives of ASA and the American Association of Nurse Anesthetists (AANA) to participate in a news conference. ASA was represented at that news conference by 2004 President Roger W. Litwiller, M.D. Several news organizations picked up the story, including CBS News, USA Today, the “Today Show” and the Associated Press. Much of the discussion in these forums surrounded the purported benefit of the bispectral index (BIS) monitor.

Concern generated by JCAHO’s apparent endorsement of the use of awareness monitors, with specific mention of the BIS monitor, prompted ASA leadership to address this issue in interviews with and letters to the media. This and other concerns, including the fact that JCAHO was attempting to set forth medical guidelines for anesthesiologists without vetting them through our professional organization, led to an AMA resolution expressing these objections.

Pediatric anesthesiologists also have expressed concern with regard to the lack of evidence for the application of the JCAHO recommendations to the care of all patients, adults and children. The lack of meaningful data relating to intraoperative recall and the role of the BIS monitor and similar monitors in the care of infants and children was and remains of particular concern. Despite a lack of supporting data, the Sentinel Event Alert made several recommendations and included specific mention of children.

In response to concerns raised throughout the pediatric community, a letter was drafted jointly by the Society for Pediatric Anesthesia, the American Academy of Pediatrics Section on Anesthesiology and Pain Medicine and the ASA Committee on Pediatric Anesthesia and sent to JCAHO for response:

Dear Dr. O’Leary:

On behalf of the undersigned organizations, we are writing to express our concern with the recently issued Sentinel Event Alert titled “Preventing, and managing the impact of, anesthesia awareness.” Our concern is focused on two issues. The first is that we believe the publication of this announcement is premature and insufficiently supported by the scientific literature, especially as it relates to anesthesia care for infants and children. This is not to say that this subject is the not the focus of considerable interest and extensive research. It is. But it is our shared opinion that the current peer-reviewed scientific literature is insufficiently developed to support the Sentinel Event Alert as published.

Our second concern is the degree in which this Alert appears to direct physicians in the clinical practice of medicine. We are not aware that this degree of specificity in the practice of medicine, especially in the practice of the specialty of anesthesiology, is within the expertise of the JCAHO. (We refer to your recommendations on drug selection, drug dosing, neuromonitoring and proscriptions regarding the use of neuromuscular blocking agents.) Furthermore, it appears from this Alert that the recommendations on “reducing the risk” and “managing the impact” of awareness under general anesthesia are based on a single publication from the February 2000 issue of Anesthesiology. Standards of care and recommendations on optimal clinical practice are rarely, if ever, based on a single or even small set of publications in the medical literature. On the other hand, if this Sentinel Event Alert is the product of a panel of experts in the fields of anesthesiology and awareness under general anesthesia, this information should have been included in the Alert.

We recommend that this Sentinel Event Alert be withdrawn until such time as there is a consensus among experts in anesthesiology that the conclusions and recommendations in the Alert are warranted. It is our opinion that these requirements are not yet met. We also wish to call your attention to the fact that the issues raised by the Sentinel Event Alert are substantially more complicated when applied to the field of pediatric anesthesiology. These complexities will require a substantially greater body of scientific evidence than is available at the present time to elucidate “best practices” in the anesthesia care of infants and children. Please let us know if we may be of assistance as you further refine this and other Alerts relating to the practice of pediatric anesthesiology. We look forward to your response.

The pediatric anesthesiology community has supported and will continue to support thoughtful, carefully conducted research into the rare problem of awareness under anesthesia. Whether or not those studies involve the use of awareness monitors remains to be seen.

Pediatric Sedation by Nonanesthesiologists
Increasingly, children who require medical procedures causing anxiety or pain are being administered consciousness-altering medications by nonanesthesiologists. This is due to the increasing number of children (and parents) who expect to undergo these procedures in a state of decreased consciousness and the simple fact that, because of workforce shortages, there are not enough anesthesiologists to be present for all of these procedures. Therefore nonanesthesiologists are administering medications that were previously deemed too dangerous to be given by anyone other than providers trained in the administration of general anesthesia. Anesthetics such as ketamine or propofol have displaced drugs in other classes traditionally thought to have a greater margin of safety, such as pentobarbital, meperidine or chloral hydrate,¹ which, until recently, have been the pharmacologic agents of choice for sedation by nonanesthesiologists.^{2, 3}

Experts in pediatric anesthesiology have expressed concern over the use of general anesthetic medications by nonanesthesiologists, in particular the medicolegal implications in the event of an adverse outcome. ASA and AANA issued an official joint statement emphasizing that propofol should only be administered by practitioners trained in the “administration of general anesthesia” who are not themselves performing the procedure.⁴ Although many nonanesthesiologists may contend that propofol deep sedation does not constitute the administration of general anesthesia, a recent study on levels of consciousness (using BIS) during propofol “sedation” found that BIS levels were consistent with those normally seen during general inhalational anesthesia.⁵

At The Children’s Hospital of Philadelphia, a more formalized sedation service is being created and will be made up of hospitalists — pediatricians specially trained in inpatient medicine. Under the auspices of the department of pediatrics, with close liaison with the department of anesthesiology, a subset of our hospitalists will staff the sedation service and supervise the administration of sedatives in a dedicated nine-bed sedation unit, the MRI suite and a variety of other outpatient and inpatient areas where painful or anxiety-provoking medical procedures are performed. Initially sedation will be accomplished using pharmacologic agents traditionally used by nonanesthesiologists such as pentobarbital and midazolam. Ketamine is expected to be used in the future and possibly dexmedetomidine as well. Propofol is not expected to be utilized by this group.

Before they can supervise sedations, these hospitalists will have received extensive education in the principles of pharmacologic sedation, the details of sedation policies and standards, and they will hold current certification in pediatric advanced life support (PALS). Hands-on training of airway rescue techniques will consist of a day on the pediatric simulator with a pediatric anesthesiologist and 10 days in the operating room with a pediatric anesthesiologist with an emphasis on learning and practicing bag-mask ventilation techniques, laryngeal mask airway insertion and endotracheal intubation. Administratively these “sedationists” will actively participate in the hospital’s sedation committee (chaired by an anesthesiologist) and develop their own internal quality improvement process.

The most important aspect of this new and innovative service will be the close association with the department of anesthesiology to discuss prospective patients and develop knowledge of their limitations, particularly with regard to children who are likely to exhibit upper-airway obstruction during impaired consciousness. In the future, it is quite likely that most children who need sedation for medical procedures will be cared for primarily by nonanesthesiologists. Anesthesiologists, however, should play a major role in the acquisition and training of these sedation specialists and hold them to the same unparalleled standard of safety that we ourselves uphold.

References:

1. Gozal D, Drenger B, Levin PD, Kadari A, Gozal Y. A pediatric sedation/anesthesia program with dedicated care by anesthesiologists and nurses for procedures outside the operating room. J Pediatr. 2004; 145:47-52.

2. Mace SE, Barata IA, Cravero JP. Clinical policy: Evidence-based approach to pharmacologic agents used in pediatric sedation and analgesia in the emergency department. Ann Emerg Med. 2004; 44:342-377.

3. Green SM, Krauss B. Clinical practice guideline for emergency department ketamine dissociative sedation in children. Ann Emerg Med. 2004; 44:460-471.

4. AANA-ASA Joint Statement Regarding Propofol Administration <www.ASAhq.org/news/asaaanajointstmnt.htm>.

5. Reeves ST, Havidich JE, Tobin DP. Conscious sedation of children with propofol is anything but conscious. Pediatrics. 2004; 114:e74-e76.

Randall M. Clark, M.D., is President, Rocky Mountain Pediatric Anesthesiology, P.C., Denver, Colorado, and is ASA Director for Colorado.

Randall P. Flick, M.D., is Head of the Section of Pediatric Anesthesiology, Mayo Clinic, Rochester, Minnesota.

Ronald S. Litman, D.O., is Attending Anesthesiologist, The Children’s Hospital of Philadelphia, and Associate Professor of Anesthesiology and Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.