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Pediatric Sedation Newsletter – Fall 2007 Departments of Anesthesiology and Pediatrics, Children‟s Hospital at Dartmouth, Dartmouth Hitchcock Medical Center, Lebanon, NH Editors: Joseph Cravero MD (email@example.com), George Blike MD firstname.lastname@example.org Website = http://an.hitchcock.org/PediSedation/ Estimated Circulation 5001 New Society!! - Society for Pediatric Sedation: We would like to begin this newsletter with the announcement of the formation of the Society for Pediatric Sedation (SPS). This society is the outgrowth of this newsletter and the Pediatric Sedation Research Consortium (PSRC) and is dedicated to the improvement of sedation care for children. We will be seeking to improve communication and to encourage the exchange of knowledge and ideas between the various providers who deliver sedation for children. We believe that the time is right to create a society that specifically addresses the needs and issues of children requiring sedation (organizing around this work) without regard to the specific training or board certification of the providers involved. The SPS will be constructed with the express purpose of allowing discussion of practice, guidelines, and research in an environment that is free of the political overtones and restrictions of specialty specific societies. Anyone interested in joining this society should review its website at www.pedsedation.org. Membership is open to all categories of providers. We are seeking individuals who are willing to engage in a lively dialogue about sedation through participation in a yearly conference, quarterly newsletter, sedation list-serve, and interactive website. We hope to develop a national training course for pediatric sedation credentialing and guidelines for safe sedation. Through our conferences and newsletters, we would like to encourage research in the area of pediatric sedation and ultimately to produce a journal of pediatric sedation that allows a single source for the publication of this research and editorials on this area of medicine. Please consider joining this new society and participate as much as you would like. Membership applications are available on the website (above). Our first meeting will take place during the upcoming Multispecialty Sedation Conference – see below. Multispecialty Sedation Conference: The 3rd International Multispecialty Sedation Conference will be held in Savannah Georgia, May 29-30 2007. This conference will be multidisciplinary in nature and focus on the theme of Safety in sedation. There will be lectures on the various drugs involved in sedation today including propofol, dexmedetomidine, etomidate, and ketamine as well as presentations of discharge criteria, safety improvement, and new data on sedation practices. Breakout sessions on various aspects of sedation practice and administration will be included. Please consider attending and participating in this forum. A formal brochure etc will be available very soon - for the moment details can be obtained by calling Jean Wiggins at 912-350-4357. Literature Reviews: #1 Chen MI, Edler AE, Wald S, Dubois J, Huang YM. Scenario and checklist for airway rescue during pediatric sedation. Simulation in Healthcare. Vol 2, No. 3, Fall 2007. This paper represents a new kind of publication that has become more and more widespread in the last couple of years. It amounts to a created “case” that can be replicated in a simulator for educational/training purposes. The interesting part of this one is that it is specifically directed at pediatric sedation and I am not aware of many other reports of this type. The authors introduce this paper by explaining that they developed a simulated sedation scenario to improve pediatric airway management instruction for moderate or deep sedation. A performance checklist was developed for this case (specifically addressing the issues related to sedation rescue performance) using expert opinion generated from a Delphi analysis of scripted and taped airway management scenarios during a moderate sedation performed by pediatric anesthesiologists. Delphi analysis is a structured process that extracts independent experts‟ predictions and opinions to generate a group consensus. The performance checklist can be used as a tool to evaluate skills and behavior necessary for airway rescue during pediatric sedation. The content of the module was designed to be specifically consistent with guidelines set forth by the American Society of Anesthesiologists, American Academy of Pediatrics, and PALS. The simulation case scenario begins by setting out learning objectives in terms of medical knowledge (etiology of airway obstruction etc.), patient care (perform common airway management techniques), interpersonal and communication skills (communicate difficulties with airway management etc.), and systems based medicine. They follow with guided study questions and references for debriefing participants in the simulated scenarios. They point out the issues that must be well understood by any participant in pediatric sedation – such as what is essential information that the participant needs to know prior to initiating moderate or deep sedation. Other questions refer to the current status of sedation recommendations from the AAP and the ASA. The preparation section of the scenario reviews monitors required, personnel required, general equipment required, and time duration of the sedation. The case stem involves a sedation provider taking over a sedation case of a 2 year old child with newly diagnosed ALL scheduled for a PICC line insertion in a procedure room. The scenario involves the nurse caring for the child unable to complete the procedure with the fentanyl and midazolam sedation that has been given. The sedation provider is asked to assist in providing more sedation for the child. The child is crying and the O2 sat is 98%. The scenario then describes the exact actions and reactions that the nurses involved in the scenario and the facilitators should undertake. Clinical and physiological changes for the patient are also carefully outlined. Instructions for ending the scenario are included, and depend on the participant completing definitive airway management. Also included in the paper are the past medical history for the patient, the complete checklist for the scenario, and an assessment key. Commentary: This particular paper might seem a bit odd to the uninitiated, but it represents an entirely new and growing area of publication. Case scenarios like this may be used at your own institution to spark interest in simulation based training for pediatric sedation training. At Dartmouth we use scenarios such as this to credential and privilege sedation providers for deep sedation. The advantages of simulation based training over other types of training, such as hands-on patient care in the OR, are clear. You can predict the response of the simulator. There is no potential injury to the simulator during the training. You can let the trainee make mistakes and learn from mistakes in a way that is not ethically possible on patients. Finally, it is just plain easier to schedule training in the simulator, and it might be a “fairer” judge of competence between providers since the scenarios can be replicated over and over in the simulator in an exacting manner not possible in the patient care environment. The obvious question remains as to whether or not this training is actually a valid measure of performance with “real” patients – that hard work is yet to be completed. So…. To give an example of the kind of work that still needs to be done in the field of sedation simulation I would point toward the paper described below: #2 Shavit I, Keidan I, Hoffmann Y, Mishuk L, Rubin O, Ziv A, Ivan P, Steiner IP. Enhancing Patient Safety During Pediatric Sedation The Impact of Simulation-Based Training of Nonanesthesiologists. Arch Pediatr Adolesc Med. 2007; 161:740-743. Objective To evaluate the impact of simulation-based education on patient safety during pediatric procedural sedation. Design A prospective, observational, single-blind, controlled study of pediatric procedural sedation outside the operating room. Setting Two university teaching hospitals in Israel. Participants Nonanesthesiologists, with or without training in simulation-based education on patient safety, who routinely perform procedural sedation outside the operating room. These comprise full-time pediatricians practicing emergency medicine and a cohort of pediatric gastroenterologists. Intervention The study investigators used the internally developed, 9-criteria Sedation Safety Tool to observe and evaluate nonanesthesiologists who were trained in sedation safety and compared their performance with that of colleagues who did not receive similar training. Outcome Measure For each of the 9 criteria on the evaluation form, odds ratios and 95% confidence intervals were calculated to compare the actions of the individuals in the 2 study groups. Results Thirty-two clinicians were evaluated. Half of the physicians were graduates of the simulation-based sedation safety course. Significant differences in performance pertaining to patient safety were found between those physicians who did and those who did not complete simulation-based training. Conclusions Pediatric procedural sedations conducted by simulator-trained nonanesthesiologists were safer. The simulation-based sedation safety course enhanced physician performance during pediatric procedural sedation. Commentary: We just wanted to provide a context for the preceding paper reviewed here. In essence what we are observing here is an evolution of the literature surrounding different areas of simulation and sedation. In the case of simulation we have some case scenarios being developed that are intended to help with training providers and students (first paper). In the case of this second paper we see authors attempting to do the (even harder) work of proving that the training provided in simulation scenarios actually improves performance – what we might term “validation” of the simulation training. This paper indicates there is improved performance in several areas on their performance checklist when simulation training is completed, but the true outcome of interest (improving the care and/or survival of sedation patients) is lacking. Actually the tool they used to “grade” performance is not (technically speaking) completely validated, and there is no specific information on the outcomes of the sedations (in terms of patient state during procedures etc.) with or without simulation training. Having made these comments we would like to congratulate the authors on this really important work. Some may find this type of literature technical and less than exciting, but think of the possibilities!- at the point where we know that good performance in a simulator truly correlates with good performance with sedated pediatric patients, it might finally end the debate as to who is qualified to give different levels of sedation using various medications, etc. #3 Heard C, Joshi P, Johnson K. Dexmedetomidine for pediatric MRI sedation: a review of a series of cases. Pediatric Anesthesia. Vol 17,(9), Pg 888-892, Sept 2007 Background: The aim of this review was to determine whether dexmedetomidine alone provided satisfactory conditions for children undergoing magnetic resonance imaging (MRI). Methods: A retrospective review of 21 patients was undertaken, (age range: 1–8 years, weight 10–27 kg) who received dexmedetomidine to provide deep sedation for an MRI procedure. Results: In the initial eight patients who received dexmedetomidine (bolus 0.5– 1.5 mg·kg1 and infusion rate 1–1.5 mg·kg1·h1) by itself, movement occurred in five of them, even when the maximum suggested dose was used (1 μg·kg1·h1). Midazolam (0.1 mg·kg1) i.v. was given as an adjunct to the following 13 patients (dexmedetomidine doses were lower: bolus 1 mg·kg1, infusion 0.5–1 mg·kg1·h1). Only one patient moved within this group. The mean time to discharge post procedure was 90 min. There were no differences with respect to recovery or discharge times between those who did or did not receive midazolam. No cardiac or respiratory complications were noted. Conclusions: The use of dexmedetomidine for MRI sedation by itself was more unpredictable than anticipated from the published case reports of its use. Commentary: So what we have here is a very small retrospective study of dexmedetomidine MRI sedation. Normally we would not include a study such as this in our newsletter, but dexmedetomidine is so “hot” right now that we thought any additional information on its use was interesting. The reports of dex use for procedural sedation are still so few that we are clearly seeing an evolution in its use and an appreciation that doses needed for children undergoing procedures like MRI are significantly higher than that needed for adults. Dr. Keira Mason (from Boston Children‟s and the author of a previous dex procedural sedation paper) recently lectured at a sedation conference in Boston and reported using significantly larger bolus doses of dex to children in order to obtain reliably sedated states. Stay tuned for more reports from that group. The addition of a small dose of a complementary drug such as midazolam may also be needed. Interestingly, the discharge times are somewhat prolonged, but these times are so dependent on the particular practice of a given institution that it is hard to say much about what this means for the rest of us. #4 Jenkins IA, Playfor DM, Bevan C, Davies G, Wolf A. Current United Kingdom sedation practice in pediatric intensive care. Pediatric Anesthesia 17 (7), 675–683 Background: The aim of this study was to investigate the current practice of sedation, analgesia, and neuromuscular blockade in critically ill children in pediatric intensive care units (PICUs) in the UK and to identify areas that merit further study. Methods: Data were gathered in a prospective observational study of 338 critically ill children in 20 UK PICUs. Results: There is considerable variation in clinical practice. A total of 24 different sedative and analgesic agents were used during the study. The most commonly used sedative and analgesic agents were midazolam and morphine. Four different neuromuscular blockers (NMBs) were used, most commonly vecuronium. There were differences in treatment between cardiac and noncardiac children, but there were a greater number of infants and neonates in the cardiac group. NMBs were used in 30% of mechanically ventilated patients. Withdrawal symptoms were reported in 13% of ventilated patients, relatively early in their stay; weaning sedative agents („tapering‟) was apparently of no benefit. The use of clonidine in this setting was noted. Physical restraints were used in 7.4%. Propofol was used but in only 2.6% of patients, all over the age of 4 years, and not exceeding 2 mg·kg1·h1. No side effects attributable to „propofol syndrome‟ were noted. Conclusions: There is considerable heterogeneity of sedation techniques. NMBs are used in a large portion of this population. Withdrawal symptoms were associated with higher doses of sedation and greater lengths of stay and were not ameliorated by withdrawing sedation gradually („tapering‟). Comment: We generally limit ourselves to procedural sedation in this newsletter, but this paper interested us from the standpoint of showing what collaborative groups can do in pointing out current practice. Clearly there is some selection bias in the choice of the PICUs that were studied. On the other hand, the data on the high frequency of use of muscle relaxants and the heterogeneity of practice is compelling, and we suggest there would be similar findings if studied in the USA. As a sedation service we are commonly asked to consult on patients in the ICU who have been on medications for a long time and (either) need more behavior control or are experiencing withdrawal. The fact that weaning of agents did not appear to change the frequency of withdrawal is food for thought and clearly needs more evaluation since it is a staple of our practice. Interestingly, some have reported that dexmedetomidine (paper #3 above) can be helpful with patients withdrawing from opioids and benzodiazepines, although definitive data is lacking at this point. #4 Milner JR, Burton JH. Clinical practice advisory: emergency department procedural sedation with propofol. Annals of Emergency Medicine. Vol 50 (2) August 2007 Comment: There is no abstract to print here. We suggest all providers interested in the ongoing debate over the use of propofol (in general) might want to read this practice advisory in its entirety. The authors discuss indications, contraindications, fasting states, personnel, pharmacology, monitoring, adverse reactions, recovery and discharge, and future research questions relating to propofol sedation in the ED setting. It is not our purpose to quibble with the conclusions the authors make from the available data, but we think there are a couple of points to make vis-à-vis the methodology used to produce this guideline with respect to pediatric patients: 1) Most concerning is the fact that this practice advisory apparently applies to all age patients (uniformly) – there is essentially no differentiation of children from adults in any of the areas of discussion mentioned above. In fact there is very little mention made of children at all. Under the section relative to “higher relative risk patients” (under the heading “age”), the only mention made of children is the fact that “the distribution and clearance of propofol in children are noted to be similar to that in adults”. No mention is made of the possible differences in risk profile of newborns vs. infants vs. toddlers vs. children vs. adults. As yet there simply is not enough data available (in the relatively few studies) that have looked at propofol sedation in children in the ED to make firm conclusions on these age differences; but lack of evidence does not mean that no difference exists, and evidence from other practice situations indicates that children are different from adults – we believe possible differences in practice technique deserve at least a mention in the body of this widely disseminated guideline. In another example, under dosing indications, the recommendation is for a dose of 1mg/kg followed by 0.5 mg/kg every 3 minutes as needed - the same for both children and all adults. This recommendation is made in spite of the fact that several studies are cited in this same section that clearly indicate higher doses are needed in children to reach clinical effect for many procedures. To their credit at the end of the paper the authors recognize that future research is needed into age differences – but this does not change the fact that the practice advisory draws conclusions without the benefit of this (to be developed) data. 2) Under “personnel” section the authors propose that a separate MD monitoring the patient may not be needed. This statement is based on one study in which a single physician sedated 250 patients with propofol without a physician monitor (and the adverse event rates were similar to those reported for 2 physician sedation). They conclude “there is no current evidence to suggest that propofol is unsafe without a second physician present”. In fact, there is no meaningful data on this issue at all – one way or the other. Once again, we would suggest that lack of contrary evidence does not prove a point. More data is needed on this issue before any conclusion could be made. It is somewhat concerning that this kind of reasoning would be used in a publication that has as much weight in the emergency medicine community as this one does – and concerning a topic where the stakes are as high as they are in this case. In the next issue of the Newsletter we will similarly review practice recommendations from other organizations. We look forward to a lively dialogue on this topic. Thanks – and we look forward to your thoughts and comments.
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