Pediatric Sedation Newsletter – April 2004 Departments of Anesthesiology and Pediatrics, Children’s Hospital at Dartmouth, Dartmouth Hitchcock Medical Center, Lebanon, NH Editors: Joseph Cravero MD (firstname.lastname@example.org), George Blike MD email@example.com Website = http://an.hitchcock.org/PediSedation/ Circulation 3425 Sedation Conference: There was an error concerning the program of events on the website announcing the First International Multi-specialty Sedation Conference. The meeting will take place on the 22nd of May, Saturday. This will include lectures, lunch time question and answer session, and afternoon break-out sessions. There will be an informational meeting about the Pediatric Sedation Research Consortium on Sunday the 23rd of May for any interested parties. An organizational meeting for current PSRC members is planned for Friday the 21st. Please look for details at http://www.thechildrenshospital.org/pro/cs/detail.cfm?RecordID=1195 Reprints: In case you were wondering…… in the past we have reprinted editorials and commentaries from various journals in their entirety here in the Newsletter after obtaining permission. After seeking approval from various journals to do this more recently we have been “discouraged” to continue. In the true spirit of the internet, we will just shift our strategy and hopefully deliver the same product without getting into trouble. Instead of reprinting an entire editorial, we will try to summarize the major points and issues raised, and point you to the full text reference. Mailbox: We had a letter from a reader recently which raised an interesting point and we seek other opinions on this matter. I have a question which maybe we can bring up with the consortium. Recently, it has been discussed if a follow up phone call should be made the day after all procedural sedations. Currently this is done by our outpatient surgery center and radiology. The phone call entails asking if there were any problems the family or child experienced. According to the radiology nurses they rarely if ever discover an adverse event. Is this a process which is done at other institutions? Should this be a standard of care? Jill Fitch MD – Columbus Children’s Hospital At Dartmouth we make a pre-sedation phone call to all patients. Like most institutions we seek to gain information on the child in terms of medical history, previous experience etc., and to give NPO guidance as well as answer any specific questions that families have about the sedation itself. Although our Same Day Surgery section makes a call to all patients post- operatively – we do not make such a call to all sedation patients. Our nursing and physician providers do call any patients who were particularly worrisome in some way (i.e. had a lot of delirium on emergence) but this is not routine. We can imagine a lot of arguments in favor of such a practice. Clearly, many children who receive sedation are not “back to normal” for a long time after their procedures. Malviya and colleagues (Pediatrics 105 (3) E42, 2000) described prolonged effects of long-acting sedatives in a cohort of pediatric sedation patients several years ago. Contacting these families routinely might help them avoid a trip to the emergency room – and help them manage a frightening situation (such as their child not “acting right” for quite a while after sedation). In the rare instance where a child is suffering prolonged nausea and vomiting or some other serious complication of the sedation, contact could enable the provider to head off a really dangerous situation. Perhaps most importantly, a consistent call would be good professional practice, resulting in increased patient satisfaction and a clearer understanding of the implications of the medications and procedures we provide. On the other hand it should be noted that in surgery circles, the post operative call is aimed as much as following up the possible complications of the procedure as much as the sedation/anesthesia. In the case where a child receives very brief sedation for a non-invasive test (i.e. CT scan), the likelihood of finding major problems with a post-sedation phone call is probably quite low. Staffing considerations aside, a post sedation call seems like an excellent idea (probably more needed in some situations than others), but as far as we know it is not a standard of care at this point. We invite reader comment on this issue. Literature Review: 1)Malviya S, Voepel-Lewis T, Ludomirsky A, Marshall J, Tait AR. Can We Improve the Assessment of Discharge Readiness?: A Comparative Study of Observational and Objective Measures of Depth of Sedation in Children. Anesthesiology. 2004,100, (2) 218-224 Abstract: The authors point out that current recommended discharge criteria might not be rigorous enough to detect residual sedation. This study evaluated the use of the Bispectral Index (BIS® monitor), the University of Michigan Sedation Scale (UMSS; i.e., 0-4 observational scale), and a Modified Maintenance of Wakefulness Test (MMWT; visual observation of the time the child is able to stay awake) in assessing return to baseline status. Twenty-nine children sedated for echocardiographic examination were studied. Nurses administered sedatives and monitored and discharged children according to institutional guidelines. Children were monitored with the BIS® throughout the study. Trained observers assigned UMSS scores every 10-15 min until revised discharge criteria were met (i.e., UMSS score of 0 or 1, MMWT duration = 20 min). The MMWT value was recorded at each observation following the procedure. Subsequently, blinded observers recorded average BIS values for the 5 min before each UMSS observation. Results showed that there were moderate correlations between the BIS, MMWT, and UMSS scores (r = 0.68-0.78; P < 0.01). Revised criteria correctly identified children who were awake and alert (BIS value = 90) in 88% of the cases. Only 55% of the children had returned to baseline BIS values when discharged by the nurse, compared with 92% when revised criteria were met (P < 0.05). It took longer to meet revised criteria compared with standard criteria (75.3 ± 76.2 min vs. 16.4 ± 13.1 min; P = 0.001). The authors concluded that the incorporation of specific, objective discharge criteria (i.e., UMSS score of 0 or 1, MMWT duration = 20 min) may ensure a status closer to baseline (BIS value = 90) compared with nursing judgment using standard criteria. However, such assurance may delay the discharge of sedated children. Commentary: Not sure what the implications are for our phone call question (above). We compliment this effort to put a more scientific framework on discharge criteria - which have previously often been described in “fuzzy” terminology concerning return to baseline status. There is no doubt that institution of more standardized and objective criteria for discharge results in patients more closely approximating their baseline status at the time of discharge. The question still to be raised after a study such as this is whether or not outcomes are changed? On face value alone, one would assume the answer to that question is “yes”, however that data is still lacking. Would the institution of these criteria help us avoid any future incidents of children being discharged after sedation with airway reflexes still significantly impaired - only to slump over and suffocate in their car seats on the way home? (Coté et. al. Pediatrics 105 805-14, 2000) Stated another way does keeping children for an extra hour after meeting a defined nursing standard (in order to pass a more rigorous set of criteria) result in prevention of significant problems? Such a follow-up study would be welcome. This study is also interesting for its use of the BIS® monitor as a standard against which to measure patients and their level of sedation. For those who are not familiar with it, the BIS® stands for Bispectral Index Score and essentially is a processed EEG that can be derived from 3 electrodes placed on the forehead. The output of this monitor reads from 0 to 100 and gives a rough evaluation of the depth of sedation or anesthesia for a given patient at that moment. The producers of this instrument have been fairly aggressive in their marketing for its use in all areas of anesthesia for many years now. I believe it would be fair to say that the response has been mixed with some centers using the instrument a lot and others using it very little. Although we have not used it extensively during pediatric sedation ourselves, we are seeing increasing use of this instrument in sedation research. While it may not, as of yet, have a role in day to day sedation work, there seems to be an evolving niche for this monitor in clinical investigation and perhaps the ICU. This article was accompanied by an editorial by Charles Coté in the same issue of Anesthesiology entitled Discharge Criteria for Children Sedated by Nonanesthesiologists: Is "Safe" Really Safe Enough? Anesthesiology 2004 100 (2) 207-9. This paper traces the evolution of guidelines for sedation and their role in helping to improve safety in the sedation practice. Dr. Coté points out the adverse events that have accompanied inappropriate discharge of patients while still sedated. He points out that parents themselves may be helpful in the prolonged observation process that may result when more strict discharge criteria are employed. He calls for more research (like that of Malviya and colleagues) where objective scientific methods are used to establish the safest possible discharge criteria. Two studies along with an editorial appeared in Annals of Emergency Medicine this winter. I apologize ahead of time for those who are tired of hearing about propofol….. 2) Bassett K E, Anderson J L, Pribble C G, Guenther E. Propofol for procedural sedation in children in the emergency department. Annals of Emergency Medicine. 2003 42, (6) 773-82. Abstract: The authors wished to determine the safety and efficacy of propofol sedation for painful procedures in the emergency department (ED). To accomplish this, a consecutive case series of propofol sedations for painful procedures in the ED of a tertiary care pediatric hospital from July 2000 to July 2002 was performed. A sedation protocol was followed. Propofol was administered in a bolus of 1 mg/kg, followed by additional doses of 0.5 mg/kg. Narcotics were administered 1 minute before propofol administration. Adverse events were documented, as were the sedation duration, recovery time from sedation, and total time in the ED. Three hundred ninety-three discrete sedation events with propofol were analyzed. Procedures consisted of the following: fracture reductions (94%), reduction of joint dislocations (4%), spica cast placement (2%), and ocular examination after an ocular burn (0.3%). The median propofol dose was 2.7 mg/kg. Ninety-two percent of patients had a transient (≤2 minutes) decrease in systolic blood pressure without clinical signs of poor perfusion. Nineteen (5%) patients had hypoxia, 11 (3%) patients required airway repositioning or jaw-thrust maneuvers, and 3 (0.8%) patients required bag-valve-mask ventilation. No patient required endotracheal intubation. Propofol sedation is efficacious and can be used safely in the ED setting under the guidance of a protocol. Transient cardiopulmonary depression occurs, which requires vigilant monitoring by highly skilled practitioners. They conclude that propofol is well suited for short, painful procedures in the ED setting. 3) Guenther E, Pribble CG, Junkins EP, Kadish HA, Bassett KE, Nelson DS. Propofol sedation by emergency physicians for elective pediatric outpatient procedures. Annals of Emergency Medicine. 2003 42(6) 783-91 Abstract: The authors describe the efficacy of propofol sedation administered by pediatric emergency physicians to facilitate painful outpatient procedures. A protocol for patients receiving propofol sedation in an emergency department-affiliated short-stay unit was instituted. A prospective, consecutive case series was performed from January to September 2000. Patients were prescheduled, underwent a medical evaluation, and met fasting requirements. A sedation team was present throughout the procedure. All patients received supplemental oxygen. Sedation depth and vital signs were monitored while propofol was manually titrated to the desired level of sedation. Results showed that there were 291 separate sedation events in 87 patients. No patient had more than 1 sedation event per day. Median patient age was 6 years; 57% were male patients and 72% were oncology patients. Many children required more than 1 procedure per encounter. Most commonly performed procedures included lumbar puncture (43%), intrathecal chemotherapy administration (31%), bone marrow aspiration (19%), and bone biopsy (3%). Median total propofol dose was 3.5 mg/kg. Median systolic and diastolic blood pressures were lowered 22 mm Hg (range 0 to 65 mm Hg) and 21 mm Hg (range 0 to 62 mm Hg), respectively. Partial airway obstruction requiring brief jaw-thrust maneuver was noted for 4% of patient sedations, whereas transient apnea requiring bag-valve-mask ventilation occurred in 1% of patient sedations. All procedures were successfully completed. Median procedure duration was 13 minutes, median sedation duration was 22 minutes, and median total time in the short stay unit was 40 minutes. The authors conclude that propofol sedation administered by emergency physicians safely facilitated short painful procedures in children under conditions studied, with rapid recovery. Comment: These studies are important to review for many reasons. First, in fairness, it should be recognized that they come from the same institution with many of the same authors on both papers. This is a critical point since (as the authors point out) their conclusions about safety are directed at the context and conditions under which the studies were performed. In this case a major children’s hospital and teaching institution. Clearly the rescue and back-up systems that are present 24 hours a day are different in this situation than they might be in a community hospital emergency department. As always, we need to note that even at several hundred patients, the numbers are very small to make sweeping generalizations about the safety of this practice. The studies are very important in that there are very few studies that systematically review the use of propofol in the emergency department involving children. As the use of propofol is rapidly becoming very wide-spread in emergency departments across the country, reports such as these are sorely needed in order to better understand the nature of propofol use and to categorize the benefits and risks. It will be reassuring when we have reports of its use in tens of thousands of patients having a wider variety of procedures and in varying venues. In describing their experience with protocol driven propofol delivery, the authors should be complimented for including their careful patient selection process. Even in the non-elective cases (Bassett), patients were all ASA I or II and had been fasted for at least 3 hours. None had significant airway abnormalities. When considering the outcomes from these studies, this screening process should be taken into account. While not readily apparent from the abstracts, both of these studies (not just Bassett) involved the use of adjunctive opiates for any procedure that was deemed “painful”. This is a critical point since movement during painful procedures such as lumbar punctures can be unacceptable if not accompanied by adjunctive opiates - unless the dose of propofol is extremely large. The opiate administered in the Guenther study was fentanyl (1-2mcg/kg) one minute prior to the administration of propofol, while in the Bassett study it was morphine for pain in the emergency department (dose determined by the emergency medicine physician) with 1-2mcg/kg of fentanyl given prior to the administration of propofol. Interestingly, the investigators did not give opiates to children who were on chronic opiate therapy when it might be argued that those patients would need the adjunctive opiates more that any other population. One real drawback of these two studies is the lack of any type of objective pain or sedation scale used to describe the state of the patients during procedures. The authors state that “non- purposeful movement that did not interfere with the procedure and verbalizations including moaning or minimal crying were tolerated without additional medication administration”. This type of methodology leaves the reader uncertain of the exact effectiveness of the sedation that was provided. With a strong enough helper exactly what type of movement interferes with the procedure? It is always hard to know how to consider the complications mentioned in studies such as these. Mild hypoxemia that is readily reversed by manipulation of the jaw or chin may not represent a major problem at all. On the other hand, the 1% incidence of apnea requiring bag-mask ventilation remains a strong reminder that only those absolutely comfortable with the management of pediatric airways should undertake this practice. The requirement for advanced airway interventions such as endotracheal intubation has been reported with propofol use in similar situations but is rare enough that it would not reliably show up in studies of this size and this patient population. Finally, we are always interested in the inclusion of hypotensive data in studies of propofol sedation. In the setting of brief sedation with a bolus of propofol in an otherwise well child, what decrease in blood pressure is unexpected and in need of intervention (or mention)? We would argue that a mild decrease in blood pressure is indeed normal after a bolus of propofol and while it should be tracked, only very significant decreases should be reported as findings that are worthy of note. These papers were accompanied by an article entitled Propofol in the Emergency Medicine: Pushing the Sedation Frontier. Annals of Emergency Medicine 2003 Vol 42 (6) 792-7. . Authors, Steven Green MD and Baruch Krauss MD, have published extensively on sedation in the emergency department and their work has regularly been a part of this newsletter. This paper reviews the previous reported literature on propofol use in the emergency department, the key points of the Bassett and Guenther studies, and the various questions that have been raised about propofol use. We will not attempt to summarize the entire content of this article - it should be read in its entirety. We would like to point out that the authors conclude that based on the information provided by the two articles mentioned above (together with sparse reported literature before this), propofol is an accepted standard of care in the emergency department. They state “some anesthesiologists will maintain that studies the size of those existing for general anesthesia, literally hundreds of thousands of cases, are necessary to validate the profile of newer procedural sedation and analgesia agents. Most established therapies are based on hundreds rather than thousands or patients, and ED practice patterns and standard of care must of necessity be based on smaller samples.” Commentary: It is interesting that the authors single out anesthesiologists in this way. We would like to note that it is not just anesthesiologists who require large numbers of patients to establish the safe use of new protocols or therapeutic regimens. However, perhaps it is their insistence on excellent evidence to guide their practice that has given anesthesiologists the best record for safety and quality improvement in the field of medicine – as noted in the last two Institute of Medicine reports on the subject. When discussing future improvements in safety related to health care, Lucian Leape comments “Anesthesia is the only system in healthcare that begins to approach the vaunted “six sigma” level of perfection that other industries strive for.”  It would be foolish to apologize for, or retreat from advocating for these standards. It should be noted that (concerning the content of this newsletter) our comments never address “standard of care” but rather the conclusions at the end of sedation studies that state “regimen X is safe and effective”. The issue of safety has to be considered in context. In this particular case we stand by the statement that roughly seven hundred encounters in less than 400 children at one institution can not begin to prove “safety” in a field where critical incidents should only occur on the order of one in tens of thousands of encounters. On the other hand, standard of care is much more difficult to define and we would not attempt to take on that task. We would also like to point out that Dr. Green and Dr. Krauss may be correct that some standards are based on “hundreds” of case experiences; and that makes sense concerning care of relatively rare entities or infrequent therapeutic strategies. In the case of propofol however, contact with emergency medicine physicians and data from the Pediatric Sedation Research Consortium would indicate that, hundreds or even thousands of children are receiving propofol in emergency departments every day. We would encourage many more reports on its usage. We believe the gold standard level of evidence for safety (as they cite for anesthesiology) really would not be that hard to come by. 1) Leape, L.L., D.M. Berwick, and D.W. Bates, What practices will most improve safety? Evidence-based medicine meets patient safety. Jama, 2002. 288(4): p. 501-7. As always we appreciate your comments and thoughts.
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