"Pediatric Sedation Newsletter –Fall 2006"
Pediatric Sedation Newsletter –Fall 2006 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 4610 estimated Lots to report since our last newsletter – we will start with news and housekeeping. Sedation Conference Columbus Ohio In May there was a very successful sedation meeting “The Second International Conference on Pediatric Sedation” held in Easton Ohio and hosted by the Columbus Children’s Hospital with Marc Leder MD as the Conference Organizer and primary host. The conference included didactic lectures covering a large number of topics including the Pediatric Sedation Research Consortium, Controversies and Common Ground in Pediatric Sedation and Analgesia Practice – An International Perspective, Sedation Credentialling and Quality Improvement, Medical Ethics and Pediatric Procedural Sedation, Sedative Agents for Pediatric Procedural Sedation: Propofol/Ketamine and Dexmedetomidine, Sedation Coding and Billing, Procedural Sedation Practices: A Survey, Myths, and Controversies. The conference also offered 14 workshops and breakout sessions – again covering a wide range of topics as diverse as New Horizons in Topical Anesthesia to Sedation for the Sexual Abuse Examination – all generally very well attended and of high value. Of note was the fact that presenters for lectures and workshops included a wide variety of pediatric subspecialty physicians, dentists, nurses and administrative personnel. The conference also included a tour of the Columbus Children’s Hospital for an up close look at the sedation service at that institution and the various locations where they work. This was the first tour of this type that we have ever seen at a conference of this type. It was extremely informative to see detail of how this sedation service (emergency medicine staffed) accomplished a large number of very diverse procedural sedations. The details brought out in a “site visit” such as this are simply impossible to accumulate in the reports or studies that are present in our collective literature. The conference organizers deserve congratulations on many levels the content was excellent, the conference setting and services were great, and the spirit was very collaborative focusing on the improvement in care of children without specialty-oriented rancor. We truly believe the practice of pediatric sedation can be advanced by gatherings such as this. Attendees agreed that a similar meeting should take place – at an interval of two years. This is being planned for March/April 2008……..so look for this in the future. Society for Pediatric Sedation By an overwhelming majority those in attendance at the Columbus sedation meeting voted for the creation of a Society for Pediatric Sedation (SPS). It was agreed that the mission of this society should be to advance the practice and research in the area of pediatric sedation. It was further agreed that this organization should be free of subspecialty affiliation as the members will come from a diverse group of pediatric specialties and provider types. In an effort to get this underway we are currently planning a preliminary meeting of an organizational Board of Directors for this society. Anyone who feels strongly about being part of this process is invited to contact Joseph.Cravero@Hitchcock.org. An initial board meeting is planned for this March in Chicago to be fair to all parts of the country. We hope to open the society up for membership this Summer. Pediatric Sedation Listserve: In the last 2 months a listserve was started for the purpose of allowing discussion of all topics pertinent to the practice of sedating pediatric patients. The list encourages the participation of all types of medical personnel providing sedation to children. The goal of this list is to encourage dialogue among providers to improve sedation practice. We have monitored the conversation to date and there appears to be conversation of a wide variety of topics that could easily be helpful to those who provide sedation to children on a day to day basis. Anyone interested in becoming part of the conversation should contact the URL http://mailman.listserve.com/listmanager/listinfo/pediatric_sedation. Sedation Newletter Newsmakers Interview: As part of our ongoing series with individuals who are leaders in the pediatric sedation field, we sat down (electronically) with Marc Leder MD of Columbus Children’s Hospital to obtain some insight into the function of their busy sedation service. The conversation is recorded below: Pediatric Sedation Newsletter: Can you tell me what is your position at Columbus Children's Hospital? Leder: I am an Attending Physician in the Emergency Department at Columbus Children’s Hospital. I am the Medical Director of the Emergency Communications Center which handles ambulance and helicopter transfers to the Emergency Department. I am also Co-Director of the Pediatric Analgesia and Sedation Service (PASS Team) for the hospital. I am an Associate Professor of Clinical Pediatrics at The Ohio State University. PSN: How did the situation evolve that the Emergency Medicine Department took over the specialty sedation service at CCH? Leder: Our Sedation Team is actually jointly run by the Emergency Department Physicians and our Intensivists. About 5 years ago we were asked to provide procedural sedation services throughout the hospital at the request of the hospitals Medical Director. This was in response to increased need that was unable to be met alone by the very busy Department of Anesthesia whose primary responsibility was to staff the operating rooms. PSN: Could you give some examples of the types of procedures that you provide sedation for? Leder: We provide all types of sedation related services. Our primary utilizer is the Department of Radiology. We provide sedation services in radiology for MRI / Nuclear Medicine / Interventional Radiology / CT / Interventional CT. In MRI and Nuclear Medicine most of the patients are recurrent Heme/Onc patients in need of follow-up studies to stage progression/remission of their disease. As such we get to know many of these patients as these studies are typically repeated about every 6 months. Our most interesting radiology cases occur in Interventional Radiology where we have provided procedural sedation services for PICC line placement, Cecostomy Tube placement, Nephrostomy Tube placement, dilatation of esophageal strictures, sclerotherapy of venous malformations, chest tube placement, motility catheter placement, steroid joint injections and other unique cases. Outside of the Radiology Suite we perform procedural sedations primarily in either the Pediatric Intensive Care Unit or Neurodiagnostics. In the PICU we commonly provide sedation for wound dressing changes, LP’s, burn care, SSEP studies, bronchoscopy, halo placement and PEG tube placement amongst other less common procedures. In neurodiagnostics we mostly sedate for ABR studies. Emergency Department procedures such as orthopedic reductions, abscess I&D etc. continue to be provided by the ED physicians working in the Emergency Department at the time and coverage for these services is currently not available through the sedation service. Our current staffing model only allows us to provide coverage for elective pre-scheduled cases. We hope to increase our ability to cover other necessary services in the future. PSN: Are you the only providers involved or are there other providers (nurses) who also provide sedation in these venues? Leder: When we attend a sedation the sedating physician is responsible for all aspects of the sedation. Columbus Children’s Hospital bylaws state that an attending physician who also has hospital sedation privileges must sign off on any sedation provided. Thus our sedation service is attending coverage only without Fellow or Resident participation at this time. Our ED and PICU fellows do provide sedation services in their respective venues but with direct attending supervision. Other providers do provide sedation services throughout the hospital most notably in radiology. Dedicated sedation nurses provide sedation services for approximately 3,000 patient encounters/year primarily utilizing a fentanyl/nembutal protocol supervised by the covering radiologist. Nurse practitioners provide similar sedation services for heme/onc patients (bone marrow biopsy/LP). PSN: How is it that a child is referred to your sedation service? Most referrals for the sedation service come directly from the procedure physician. We have developed protocols for scheduling SSEP studies, ABR’s etc. because of the high demand. Many patients also request our service for repeat studies once they have received sedation from the service as our patient satisfaction rates are high. One unique aspect of our service is that most of the cases referred to us from radiology are either patients who have previously failed sedation from the radiology sedation nurse Fentanyl/Nembutal protocol or who are deemed to challenging for sedation by the radiology sedation nurse service. PSN: Do you have a method of determining which children are sent to the sedation service and who would receive oral sedation from a nurse service? Leder: Currently there is not a central processing/triage center for all sedation requests. This is a future goal that we have for our service. Ideally all requests for procedural sedation services will come through a central processing area where based upon previously developed criteria patients can then be scheduled for procedural sedation by the most appropriate provider. PSN: How does your service interact with the Anesthesiology Service at your institution? Leder: Up to about six months ago there was no interaction with the Department of Anesthesia regarding the sedation service. As directors of the sedation service we recognized that services were being provided in parallel by our team and the Anesthesia Department without any coordination. This was leading to challenges in providing adequate patient care. We recognize the need for a unified sedation service that would allow for any sedation request to be met by appropriately triaging patients to the proper provider. In the past six months,after administrative changes occurred within the Department of Anesthesia, as well as with the encouragement and support of Hospital Administrators we have begun discussions with the Department of Anesthesia to unify our services. We hope these discussions lead to a service where guidelines can be put into place so that patients can receive proper resources after referral to a centralized sedation processing unit. We wish to provide all levels of sedation service from light sedation to general anesthesia with the added back-up and support of Anesthesiologists who could provide needed services for those patients deemed appropriate for Anesthesia consultation. Ex. ASA III or IV, challenging airways secondary to obesity or congenital abnormalities etc. PSN: Do any physicians other then EM MD's work on the service? Leder: Currently the team is comprised of 13 Pediatric Emergency Physicians and 6 Pediatric Intensivists. PSN: What is the biggest challenge you have faced in setting up your sedation service? Leder: We have faced numerous start-up challenges. The biggest challenge has probably been the steep physician learning curve. At the beginning of the service we had 2-physicians working together on cases until each developed the necessary comfort level to work independently. This required dedicated physicians who were willing to shadow their colleagues in addition to their normally scheduled work hours. The benefit to beginning the service in this manner was that it really helped create the concept of a true “Sedation Team”. Some of the early challenges that we faced included working outside of the normal comfort zones of the ED or the PICU; working alongside unfamiliar support staff ex. Nurses, MRI/Nuclear Med techs, surgeons etc.; unfamiliarity with equipment ex. Infusion pumps; sedating for unfamiliar procedures. PSN: What do you consider your biggest success in setting up this service? Leder: We have multiple success stories. The biggest is properly that we can not possibly meet the growing demand for our services. Be prepared because “if you build it they will come”. The hospital has recognized our success and has met with us to discuss physical plant changes to provide for a dedicated procedural sedation unit and the needed recovery space. Hospital administrators and others have recognized that we are able to provide excellent patient care and also make the process more efficient leading to increased patient throughput. After overcoming some initial hurdles insurers are now appropriately reimbursing for our services thus making it an economically viable service. PSN: Without getting into details about finances, can you say that your service makes money or loses money? Leder: The service is now making money by improved physician billing and increased reimbursement for the services provided. Indirectly the hospital is also benefiting by increased efficiency leading to decreased wait times for needed services as well as increased customer satisfaction. PSN: What do you see as the future challenges for your service - where are you going with this service? Leder: Our biggest challenges are forthcoming as we attempt to devise a truly unique service that will work with the Department of Anesthesiology to provide all necessary sedation services throughout the hospital. Repairing old wounds, defying previous hospital culture and traditions will have to be overcome to make this leap possible. We feel we have the right leadership, support and personalities now to go forward with this project which I am confident will ultimately provide better care to our patients. I am excited about the future of the service as it continues to expand and have its own dedicated physical space in the new Children’s Hospital construction project currently being designed with groundbreaking in 2007. PSN: Thanks!!! Pediatric Sedation Research Consortium: The Pediatric Sedation Research Consortium (which was born out of this newsletter and the first Pediatric Sedation Conference) has now catalogued over 50,000 sedation encounters at participating institutions. The results of analysis from the first 30,000 cases was published in the September 2006 issue of the journal Pediatrics p 1087. We include the abstract here: Cravero JP, Blike GT, Beach M et. al. Incidence and nature of adverse events during pediatric sedation/anesthesia for procedures outside the operating room: report from the Pediatric Sedation Research Consortium. Pediatrics. 2006 Sep;118(3):1087-96. Objective. We sought to use a large database of prospectively collected data on pediatric sedation and/or anesthesia for diagnostic and therapeutic procedures to delineate the nature and the frequency of adverse events that are associated with sedation/anesthesia care for procedures that are performed outside the operating room in children. Methods. Data were collected by the Pediatric Sedation Research Consortium, a collaborative group of 35 institutions that are dedicated to improving sedation/anesthesia care for children internationally. Members prospectively enrolled consecutive patients who were receiving sedation or anesthesia for procedures. Data on demographics, primary illness, coexisting illness, procedure performed, medications used, outcomes, airway interventions, and adverse events were collected and reported on a Web-based data collection tool. Results. A total of 26 institutions submitted data on 30037 sedation/anesthesia encounters during the study period from July 1, 2004, to November 15, 2005. Serious adverse events were rare in the institutions involved in this study; there were no deaths. Cardiopulmonary resuscitation was required once. Less serious events were more common with O2 desaturation below 90% for >30 seconds, occurring 157 times per 10000 sedations. Stridor and laryngospasm both occurred in 4.3 per 10000 sedations. Unexpected apnea, excessive secretions, and vomiting had frequencies of 24, 41.6, and 47.2 per 10000 encounters, respectively. Conclusions. Our data indicate that pediatric sedation/anesthesia for procedures outside the operating room is unlikely to yield serious adverse outcomes in a collection of institutions with highly motivated and organized sedation services. However, the safety of this practice depends on the systems' ability to manage less serious events. Commentary: OK – there is no commentary on this one – since it came from us. We would point out that the literature has previously lacked very large cohorts of sedation subjects in order to estimate the incidence of adverse events as recorded in this study. Having said this, there are always difficulties with these types of registries – most important being the reliability of the data. As outlined in the methods of this paper we depend on the PI’s at each institution to assure appropriate reporting and counting of cases to be sure a representative sample is sent from each institution. Reporting is blinded to minimize any disincentive to report adverse events. We hope continued collection of the data will help us further define concerning trends in sedation provision and allow us to highlight areas that are ripe for further investigation. Left open after investigating this data and writing this paper is the issue of what (really) represents an adverse event. Are minor oxygen desaturation events meaningful? Will a large number of these events ultimately signal a system where more significant adverse events occur? As the database continues to grow it will hopefully lead to answers to questions such as this and also point toward practice patterns and drugs that deserve closer evaluation in prospective randomized trials. Literature Review: Voiding Cystourethrogram Sedation – Necessary or too much of a good thing? We would like to point out the issue of sedation for VCUG testing. This is an issue we realize has strong emotional responses from patients, families, and sedation professionals. Some actually feel that sedation for these tests is absolutely necessary to prevent the discomfort and emotional distress associated with these tests. Others are concerned that we create a population of emotionally scarred individuals by performing hundreds and thousands of these procedures with appropriately eliminating memory or anxiety. Over the past several years (based on requests from families) we have started sedation services for VCUG’s. patients and their families like the service but we are challenged to provide care to an ever- increasing population that wants this service. We would like to present a couple of studies here and ask our readership to respond to the questions of “if?” and “how?” this service should be provided. 1. Stokland E, Andreasson S, Jacobsson B, Jodal U, Ljung B. Sedation with midazolam for voidingcystourethrography in children: a randomized double-blind study. Pediatr Radiol 2003 33:247-249. Abstract excerpted: Sedation with midazolam facilitates the performance of diagnostic procedures in children, including voiding cystourethrography (VCUG). However, the influence of sedation on voiding and imaging results have not been adequately evaluated. Madazolam (0.2mg/kg intranasal) and placebo (nasal saline) were compared to assess discomfort during VCUG and to evaluate if sedation influenced the outcome of the examination. The study was prospective, randomized and double blind, and included 95 children, 48 in the midazolam group (median age 2.2 years( and 47 in the placebo group (median age 3.2 years). The evaluation included the child’s parent’s experience of the VCUG, as well as the examination results. The children/parents in the midazolam group experienced the VCUG as less distressing compared to those in the placebo group (P<0.001). Forty –six of 48 children sedated with midazolam could void during the imaging procedure compared to 38 of 47 children given placebo (NS). There was no difference in frequency or grade of vesicoureteric reflux or bladder emptying between the groups. The authors conclude that when sedation is required to perform VCUG in children, midazolam can be used without negative effect on the outcome of the examination. Commentary: As there are very few studies of this procedural sedation, we begin by complementing the investigators for taking this on. Having said this, a few comments are required. This was a blinded study involving a somewhat noxious stimulus (nasal spray) to begin with. So, before the VCUG has even started, many of the children would be unhappy with the procedure. We have spoken to many clinicians who feel that VCUG’s can be performed well (without traumatizing a child) when very gentle, very experienced, providers are performing the procedure without sedation. In light of this, a more fair comparison might have been to use the midazolam intervention vs. the best possible practice by people who feel they do this well without sedation (and leave out nasal saline that makes the child cry to begin with). There is no description of exactly how far the investigators went to calm the children during the procedure so we are uncertain how much effort was made in this regard. Essentially we are not sure if the placebo arm of the study is a reasonable comparison group for those wondering if sedation is really needed. We are aware of a number of urologists who believe that any sedation given during a VCUG may change the outcome of the examination. We are somewhat satisfied by the fact that the reflux incidence was the same between the groups. Perhaps more importantly, the researchers noted that (by the judgment of a blinded radiologist) there was no difference in residual volume at the end of the study. This would argue that the quality of the study was likely similar although there is no assessment of the quality of the voiding or the strength of the stream of urine that could possibly impact the percentage of reflux. 2. Zelikovsky N, Rodrique JR, Gidycz CA, Davis MA. Cognitive behavioral and behavioral interventions help young children cope during a voiding cystourethrogram. Journal of Pediatric Psychology Vol 25, no 8, 2000 pp 535-543. Abstract excerpted: The authors sought to reduce young children’s distress and increase coping behavior among children undergoing a voiding cystourethrogram. In the study three to seven year old children were stratified based on prior VCU experience and randomly assigned to an intervention (n = 20) or a standard care (n = 20) condition. The intervention included provision of information, coping skills training, and parent coaching. We hypothesized that the intervention would reduce children’s distress as assessed by child report, parent and technician ratings, and behavioral observations. Children in the intervention displayed fewer distress behaviors and greater coping behaviors and were rated as more cooperative than children receiving standard care. Children’s fear and pain ratings did not differ significantly between groups. The authors conclude that a cognitive-behavioral treatment package effectively reduced children’s distress, increased coping, and increased cooperation during voiding cystourethrogram procedures. Further, they believe that this type of an intervention should be integrated into routine pediatric radiological procedures Commentary: Once again the authors are congratulated for taking on a difficult comparison such as this. The study is complex – there are multiple psychological measures and a lot of comparative statistics to sift through. Those interested in this type of intervention and VCUG’s in general should read the entire paper. With this in mind, we would like to point out a few issues relating to the conduct of the study. It is interesting to note that participants were first separated into those who had previous VCU’s and those who had not previously been studied. Unfortunately there was no attempt made to “grade” previous experience i.e. was it traumatic or not? We know that previous experience is a major determinant of current satisfaction and it may be that if the previous experience was negative any effort to improve the experience would be graded highly – even if it were not very effective. It would be helpful to have a table that described in some way the previous experience so we could be sure these groups were similar. The intervention involved included information about the VCUG and a demonstration of the procedure using an anatomically correct doll. In addition, the intervention children were taught coping strategies and parents were trained to coach their child in multiple ways. Families assigned to the standard care condition did not receive any information or coping skills training. In this way it is a little hard for us to say which of the several interventions really made a difference here since the control group got so little and the intervention group got so much! Blinding of the providers involved is also somewhat of an issue here. The investigators state that they used a counter-expectancy rationale to blind the technical personnel. The fact that there were two separate conditions was not disclosed. Technicians were told that although in some cases they may not observe the children using coping strategies, all children participated in an intervention and could be using cognitive techniques not overtly observed. While we understand the logic of this, we find it hard to believe that over the course of the 40 examinations the technicians did not eventually see clear trends in behavior and coping techniques that would make them pretty sure of who received intervention and who did not. Blinding remains a problem here, especially in light of the subjective scales used to measure the effectiveness of intervention. Finally it should be noted that while the intervention made a statistical difference, it is clear that a significant number of children in the treatment group had problems with the procedure. In fact the children themselves did not think it helped! While we are sure behavioral training helps in VCU procedures, we believe more careful analysis of exactly what is the interventions that make a difference and which children do well without intervention remains to be completed. Please send us your thoughts and commentary!!!