A while back there was some discussion about patient/parent surveys for pediatric sedation. Teresa Wheeler-Scott from the Randall Children’s Hospital in Portland, OR has graciously agreed to post the surveys that they use at their institution. Please click on any of the links below to download the surveys.
The Society for Pediatric Sedation has partnered with Vanderbilt University School of Medicine to develop online CME for physicians. We are pleased to release this first activity.
The pre-sedation assessment is probably the most important aspect of the pediatric sedation encounter. It is during this assessment that risk factors for sedation-related adverse events may be identified. It is often assumed that the pre-sedation assessment begins when the patient arrives to the hospital prior to their scheduled procedure. In reality though, the pre-sedation assessment should begin in the pediatrician’s office. It is the pediatrician that is most familiar with the patient’s history. In many cases, a careful pre-sedation assessment by the pediatrician will uncover potential risk factors that may need to be further evaluated (like a history suggestive of Obstructive Sleep Apnea) before referring the patient for sedation.
The purpose of this CME activity is to present a general framework for pediatricians to perform a pre-sedation assessment in the office at the time the decision in made to order sedation. Performing this assessment is critical to ensure patients are triaged appropriately based on well-identified risk factors, and when appropriate referred for additional evaluation prior to the scheduled procedure. Taking a few minutes to do this in the office will help to avoid unnecessary delays and ensure patient receive the appropriate level of care.
The Board of Directors has developed a consensus document related to the core competencies for providers of deep sedation. This document is now published on our website and will hopefully assist our members in working with their own institutions related to education and credentialing of sedation providers. These recommendations were made and unanimously agreed upon by the Board of SPS. Comments and suggestions are welcome.
Over the last decade the field of pediatric sedation has evolved into a specialty within a specialty. At some institutions this specialty is within anesthesiology and at others it is within a pediatric specialty (critical care, emergency medicine, or hospital medicine). While the provider type may vary between institutions (and even within institutions), the majority of sedation programs use anesthesia codes to bill for their professional fees. This raises the question… “Are providers being compensated based on the service that they provide (and bill) or based on the market rate for their respective board certification?” Earlier this year Dr. Shakari Narayan sent out a survey across the SPS listserv looking at physician compensation for sedation services.
MAC or Moderate Sedation?
This is a topic of some controversy in the sedation community. On the one side is a group that maintains anesthesia codes (MAC) are exclusively to be used by board certified anesthesiologists providing anesthesia care. On the other side, the group that maintains anesthesia codes are based on service provided, not provider board certification. There are valid arguments on both sides of the aisle and this post is not an attempt to address this controversy.
One thing is certain though… if anyone wants to generate an income by providing sedation services to children, they cannot do so by billing moderate sedation codes. The reimbursement for this service is so poor as to be almost laughable. This is not to mention that the level of service provided when placing a patient on a propofol infusion is clearly not within the scope of “moderate sedation.”
Perhaps the best reference to address this issue is the most recent interpretive CMS guidelines on pediatric sedation. I feel like these guidelines clearly address this issue:
Monitored anesthesia care (MAC):
anesthesia care that includes the monitoring of the patient by a practitioner who is qualified to administer anesthesia as defined by the regulations at §482.52(a). Indications for MAC depend on the nature of the procedure, the patient’s clinical condition, and/or the potential need to convert to a general or regional anesthetic. Deep sedation/analgesia is included in MAC.
General anesthesia, regional anesthesia and monitored anesthesia, including deep sedation/analgesia, may only be administered by:
- A qualified anesthesiologist
- An MD or DO (other than an anesthesiologist);
- A dentist, oral surgeon or podiatrist who is qualified to administer anesthesia under State law;
- A CRNA who is supervised by the operating practitioner or by an anesthesiologist who is immediately available if needed; or
- An anesthesiologist’s assistant under the supervision of an anesthesiologist who is immediately available if needed.
Thus, the practice of different physicians specialities providing deep sedation, billing MAC, and collecting the appropriate reimbursement seems to be well supported.
Based on Board Certification
Physicians these days are becoming employees. Many employers (hospitals) set market-based salaries which are loosely based on national or regional data, and may or may not be correlated with actual collections. In this model there is a fairly consistent increase in salary as you compare general pediatricians/hospitalists to sub-specialist pediatricians and anesthesiologists. A recent survey sent out to the SPS listserv confirms this trend of Board Certification based compensation for sedation providers.
While it is easy to find salary ranges for all the various fields of medicine, the exclusive (or partial) practice of pediatric sedation is much more obscure. Thus it reasons that most people just get paid what they would have otherwise been paid (based on board certification). However, given that all providers are using the same billing codes and essentially generating the same collections, there are two potential problems:
- Higher compensated providers may be overcompensated based on revenue generation.
- Lower compensated providers may be under-compensated based on revenue generation.
The pediatric anesthesiologist
I have heard it argued (#1 above) that a sedation service is unable to generate enough revenue to support the market-rate based salary for a pediatric anesthesiologist. However, Joe Cravero, at an SPA Presentation in 2010, was able to show that a well-designed anesthesiologist based sedation program could not only support itself but also generate a positive operating margin.
The pediatric sub-specialist
The market based rate for a pediatric sub-specialist is not markedly different from an anesthesiologist. Given that most will split their time between sedation and their pediatric sub-specialty, there is probably very little “under compensation” by paying pediatric sub-specialists their market-based salary.
The pediatric hospitalist
This is where the potential gap in revenue generation versus provider compensation starts to widen. The most recent data for general pediatrician compensation as of May 2011 is $198, 379. However, general pediatricians that practice exclusively hospital medicine generally are compensated about 15% less than a general pediatrician in an office based practice. So the gap between what a pediatric hospitalists might get paid ($160K) and the revenue generated (enough to support a pediatric anesthesiologists salary) can be quite substantial.
Many hospital medicine physicians are actually subsidized by the hospital. This is a consequence of volume based productivity. It is just not possible to see enough patients in a hospital-based setting (15-20/day) to generate enough revenue to support a physician salary. So a deep sedation service actually makes good financial sense for a pediatric hospital medicine practice. It allows the practice to provide a service that generates revenue to offset some of the losses from providing inpatient care.
While I have not run the numbers, I would expect that a combination of time on a sedation service and on a hospital medicine service would strike the right balance and make hospitalists a financial asset to an employer. This model is being developed at our institution and I think it will likely become the model for this evolving pediatric sub-specialty in many other institutions as well.
Comforting and reassuring children during painful procedures is a natural instinct for many people. But what we think should be comforting is not always as it seems. I would like to thank these authors for embracing the task of understanding why “comforting” statements may not comfort children, but often results in increased fear and distress.
This article (published in the July 2010 issue of Pain) is the first step to understanding what is it about our language that is comforting and what increases fear and anxiety. It examines not only the word choice, but also intonation and facial expression of the individual speaking. While most of the tests showed only small effect size, it provides us with the initial clues as to how to better construct phrases and to be more aware of tone of voice.
While most of the outcomes of this study may seem very logical to those who frequently work with children, it is reassuring to have some evidence to support those beliefs. For example, one would assume that distraction would be interpreted as less fearful than reassurance. It is interesting that neither non-informative reassurance nor informative reassurance would be interpreted by children as less fearful. It also seems logical that children in this age range would be able to interpret happy facial expressions that could outweigh their interpretation of what was being said or the associated intonation changes. However, it was very interesting to note that when children were interpreting fearful facial expressions, children tended to rely on the vocal cues more to understand the information being present. While few of the results showed a large impact it continues to encourage us to think about what is being said and how it is said.
While I find this article fascinating and look forward to learning more about how to optimize interactions with children during painful procedures I question how often children in a painful situation are actually looking at the parent when they are “comforting” them. Many “comfort” positions we employ for children in the 5-10 year old age range are either being hugged by the parent, with the face of the child either turned to the side or gently snuggled to the chest, or sitting on the parent’s lap facing away from the parent. While it is clear from this study that facial expression provides more reliable information to the child than content of speech or intonation the opportunity for visualizing parents during painful procedures seems quite limited. Perhaps that question will be answered in future research.
Peggy Riley, RN, MN, MPH
A question was recently posted on the listserv asking about the sedation practice of different practitioners when it comes to the patient with obstructive sleep apnea (OSA). As is often the case, there was a spectrum of responses. One comment referenced the ASA guidelines on the perioperative management of OSA. The goal of this post is to review these guidelines and reflect on their recommendations as it relates to deep sedation in the non-operative setting.
OSA Identification and Assessment
None, Mild, Moderate, Severe
This can readily be determined by a sleep study. However the reality in clinical practice is that many pediatric patients with signs and symptoms of OSA have not had a sleep study. In this case the advisory committee suggests:
Such patients should be treated as though they have moderate sleep apnea unless one or more of the signs or symptoms is severely abnormal (markedly increased BMI, respiratory pauses that are frightening to the observer, or the patient regularly falls asleep within minutes after being left unstimulated).
Based on this criteria there are a considerable number of my own patients that would be classified as having moderate sleep apnea by history and physical alone… and a handful that would be classified as severe.
OSA Scoring System: Perioperative Risk
Standard, Increased, or Significantly Increased?
Once you have classified the patient’s OSA, then you are advised to assign an OSA Score to better define their perioperative risk. This risk can be broken down to standard (o-3), increased (4), and significantly increased (5 or 6). Risk is scored from three different categories:
- Severity of OSA
- Invasiveness of surgery and anesthesia
- Requirement for postoperative opioids
The first is easy to define but the other criteria are difficult to extrapolate to our specific patient population.
General Anesthesia with a secured airway?
The guidelines seem to indicate that for those patients who are at increased perioperative risk due to the OSA… general anesthesia with a secured airway is the preferred practice. This is confirmed based on a follow-up questionnaire sent to 68 anesthesia consultants who preferred GA with a secured airway to deep sedation for increased risk patients.
A few Problems
What is deep sedation?
As with many issues that are broadly aimed at perioperative management, this guideline is difficult to apply to the specific situation of deep sedation in the non-operative setting. This scoring system starts patients off at a score of 2 for moderate OSA and 3 for severe OSA. The rest of the scoring system is difficult to apply to the pediatric sedation population that we see because deep sedation is not well defined (only moderate sedation versus general anesthesia).
Again these guidelines are designed for the perioperative management of patients expected to have surgery. Much of what we do is very different from surgery. Most is far less risky. However some things, like a long MRI study with poor access to the airway, may actually be more risky.
Tonsils, obesity, or both?
The other confusing issue is that OSA in the pediatric population is generally seen in 2 fairly distinct populations – younger children with adenotonsillar hypertrophy and older adolescents with obesity. The pathology and management of sedation related complications may differ considerably between the two.
East Tennessee Children’s Hospital
Clinical Practice Guideline
Based on the article above, and in light of the problems associated with the application to pediatric sedation outside the OR, the East Tennessee Children’s Hospital drafted a Clinical Practice Guideline for the sedation management for OSA. This is one institution’s solution to the problem.
What is your practice?
There are still many factors that remain unclear. Especially specific patient factors like snoring, tonsils, and fat distribution. It has also been the observation of some that age plays a role (perhaps younger kids with a higher BMI tolerate procedures better than their older counterparts)? This is certainly an area in need of further clarification by well controlled clinical trials. Leave a comment below and tell us about your approach to pediatric sedation for children with OSA.
In the above mentioned article, the authors describe a small series of patients (n= 20) ranging in age from 4-12 years undergoing bone marrow aspirations after receiving procedural sedation with a 1:1 admixture of propofol (10mg/ml) and Ketamine (10 mg/ml)[Ketofol]. The children received 0.5 mg/kg aliquots through peripheral IVs at one minute intervals until the desired sedation level was attained (Ramsey score 3-4). All of the procedures were successful. The median dose of Ketofol was 1.25 mg/kg, median recovery time 23 minutes, and a low incidence of injection site pain, emergence phenomena, and/or diplopia. No adverse airway or hemodynamic issues occurred.
This small study demonstrates the efficacy of a combination of Ketamine and Propofol mixed in one syringe to adequately sedate children for short painful procedures. Clearly the numbers are too small to make any assumptions regarding the overall safety of Ketofol. Recovery time seems to be favorable. This study does not include toddlers or teenagers for whom adverse affects may be more significant. I would caution against extrapolating the use of Ketofol for lengthy procedures when pain is a small aspect of the procedure and the need for sedation is prolonged (i.e. PICC line insertions).
Contribute to the Discussion
Your experience and comments play an important role in understanding the clinical implications of this article. Please take a few minutes to comment on your experience or express your opinion on the clinical utility of ketofol.
The above mentioned article describes a prospective case series evaluating the effectiveness, recovery time and adverse events associated with intravenous (IV) ketofol (mixed 1:1 ketamine-propofol) for emergency department (ED) procedural sedation and analgesia (PSA) in children. Multiple previous studies have shown the effectiveness of achieving moderate to deep sedation using propofol alone. In addition, propofol is short acting and has unique anti-emetic qualities. The mean doses, as reported in the literature, required for sedation with propofol alone ranges from 2.8 – 3.5 mg/kg. However, as a pure sedative with no analgesic qualities, propofol has most often been combined with a narcotic analgesic, such as fentanyl and alfentanyl, when used for painful procedures.
The main concern with propofol, with or without analgesics, is dose-dependent respiratory depression and hypotension. Ketamine, on the other hand, has the unique qualities of providing analgesia at low doses and very predictable “dissociation” at higher doses (typically greater than 1.0 – 1.5 mg/kg/IV). The main concerns with the use of ketamine is emesis (reported to be 8.4% in a recent meta-analysis), clinically important recovery agitation (reported to be 1.4% in a previous study), and laryngospasm (1.4% reported in a recent meta-analysis). The study rational was that the combination of ketamine and propofol would be beneficial in that the sedative effects of propofol would balance the nauseant and psychometric effects of ketamine. In addition, the combination would be both effective and safe in producing deep sedation for painful procedures due to the lower doses required compared to the use of either agent alone.
Of the 219 children given this combination, sedation was deemed effective by the treating physicians and nurses in all of the patients. However, there was no objective measure of the depth of sedation, so it is unclear the true depth of sedation achieved in each patient. The median dose of ketofol was 0.8 mg/kg (range 0.2 to 3.0 mg/kg), with 96% receiving less than 1.5 mg/kg of each drug. This is less than the median dosages normally required to achieve deep sedation with either agent alone. With respect to recovery time, children receiving this medication had a median recovery time of 14 minutes (range 3 to 41 minutes), which is longer than the reported recovery time of propofol alone but shorter than that of ketamine alone (25-103 minutes reported in previous studies). Emesis did not occur in any of the patients, emergence phenomena requiring intervention occurred in two patients (0.9%), and airway interventions were required in 3 patients (1.4%, but none requiring endotracheal intubation).
1) There was no objective measurement of depth of sedation; 2) The mean age was 13 years, with only 10% of patients under 2 years of age receiving ketofol, so the effectiveness and safety in patients under 2 years of age remains uncertain; 3) The majority of the patients had two Emergency Department Physicians (EDPs) present for the procedures, which may not be practical in other settings. As such, no definitive conclusions with respect to improved ED flow or reduced costs can be drawn from this study.; 4) This was not a randomized trial so, based on this study alone, no definitive conclusions can be made as to the improved efficacy of achieving adequate sedation of ketofol over other medications or combinations of medications, including ketamine alone, propofol alone or propofol with an opiode. There is also no mention of the relative and absolute contraindications of the use of dissociative doses of ketamine, especially active bronchospasm, airway abnormalities, increased intra-ocular pressure or increased intra-cranial pressure. As such, no definitive conclusions as to the improved efficacy of achieving adequate levels of sedation when using of ketofol over ketamine alone, or ketamine with other agents. As such, larger, multi-centered randomized trials are needed to support any conclusions as to the improved efficacy of this combination of medications; 6) The study is underpowered to draw definitive conclusions with respect to rare, but serious, adverse events.
1) In children over the age of 2 years of age, ketofol (mixed 1:1 in a single syringe), appears to be an effective combination in achieving adequate sedation for orthopedic procedures and lacerations (together accounting for 87% of the patients given ketofol in this study); 2) In this small cohort, serious airway events in children over 2 years of age seem to be rare and comparable to other regimens utilizing propofol and ketamine; 3) Vomiting occurs less often with ketofol compared to historical controls that were sedated with ketamine; 4) Hypotension occurs less often with ketofol compared to historical controls sedated with propofol; 5) The median recovery time is faster with ketofol compared to ketamine.
Contribute to the Discussion
Your experience and comments play an important role in understanding the clinical implications of this article. Please take a few minutes to comment on your experience or express your opinion on the clinical utility of ketofol.
Invited Commentary By:
Robert G. Flood, MD
Director, Pediatric Emergency Medicine
Cardinal Glennon Children’s Hospital
Dr. Mick Connors recently posted a question on the listserv…
How many people are using glycopyrrolate for pediatric sedation?
A little background
There are many reports in the literature of increased perioperative adverse respiratory events associated with nasal congestion and upper respiratory events. It has been suggested that glycopyrrolate may reduce the incidence of these adverse events through anticholinergic mechanisms that reduce secretions. However, a recent study failed to show a reduction in adverse perioperative events in children with upper respiratory infections undergoing general anesthesia.
Ketamine is common agent used for procedural sedation in the emergency department setting. In addition to its sedative properties, ketamine is a potent sialogogue. Historically, standard practice was to administer an anticholinergic, such as gylcopyrrolate, prior to ketamine administration to prevent adverse respiratory events. Published observational studies offer conflicting results as to the effectiveness of this regimen. However, a recently published meta-analysis, failed to show any benefit and suggested that patients who received glycopyrrolate may have an increased incidence of adverse respiratory events.
The Rationale for Glycopyrrolate
Despite these conflicting studies, it is still common practice in many centers to administer glycopyrrolate to children with increased secretions who will have deep procedural sedation with propofol. There are many reasons to believe glycopyrrolate might be beneficial in this patient population. As opposed to the study looking at perioperative events, many of these patients are receiving deep sedation with propofol for non-invasive procedures (like MRI). These patients are generally lying supine for long periods of time (45 minutes or longer). Since secretions are likely to pool in the posterior pharynx in the supine position, it reasons that decreasing secretions may be helpful. Further, since most patients that receive propofol for deep sedation do so without an ETT or LMA, their airway is not protected from these secretions which may result in an increased incidence of adverse respiratory events.
The lack of benefit suggested by the observational studies with ketamine is difficult to extrapolate to the patient population that receives deep sedation with propofol. The studies with ketamine are generally for brief dissociative sedation for painful ER procedures. Conversely, deep sedation with propofol for MRI is a much longer procedure, which for the reasons above may represent different risks associated with secretions.
Interestingly, a recent abstract presented at the SPS Annual Conference showed that patients receiving brief deep sedation with propofol +/- fentanyl had an association between pre-procedure anxiety and adverse respiratory events. It could be reasoned that many of these patients with anxiety are also crying and have increased nasopharyngeal secretions. Thus an agent that helps dry the mucous membranes may be helpful in this setting.
The Listserve Responses
From my observation on the listserve it would seem that most physicians choose one of four options:
- Use Glycopyrrolate
- Use Saline and Nasal Suction
- Use Neosynephrine Spray
- Do Nothing
What would you do?
Hollman G, et. al. Relationship of pre-sedation anxiety in children undergoing invasive oncologic procedures and induction compliance, recovery patterns, and adverse events. SPS Annual Conference. 2010
A few months ago Dr. Ed Goroza asked an interesting question:
How do sedation providers approach the child with a history of anaphlyaxis to eggs when it comes to the use of propofol?
While most anesthesia texts and “experts” in the field do not think that egg-allergy is a true contraindication to the use of propofol, it still seems that many are reluctant to use it in the egg allergic patient.
Anesthesia and Analgesia
Here is an exert from Anesthesia & Analgesia that highlights some of the current science surrounding the issue:
Propofol was originally formulated with the surfactant Cremophor EL, but a series of hypersensitivity reactions prompted a change in the formulation (36,71,72). Propofol (2,6-diisopropylphenol) is currently formulated in a lipid vehicle containing soybean oil, egg lecithin, and glycerol. The incidence of anaphylactic reactions with the new formulation is 1 in 60,000, although it has been reported to cause 1.2% of cases of perioperative anaphylaxis in France (73). A more recent report from the same group in France demonstrated that 2.1% of cases of intraoperative anaphylaxis are due to propofol (5). In a report of 14 patients with documented propofol allergy on first exposure, the 2 isopropyl groups of the propofol were thought to be the sensitizing epitopes (36). Isopropyl groups are present in dermatologic products and may account for anaphylactic reaction to propofol on the first exposure. In addition, there is a report of an anaphylactic reaction to propofol at the time of the third exposure to the drug (72). Phenol may have acted as an antigen and produced sensitization that led to an episode of anaphylaxis on reexposure. Most cases of drug allergy to propofol are IgE mediated, and specific IgE RIA and intradermal skin tests have been reported (36).
Propofol is formulated in a lipid emulsion containing 10% soybean oil, 2.25% glycerol, and 1.2% egg lecithin. The egg lecithin component of propofol’s lipid vehicle is a highly purified egg yolk component (74). Ovalbumin, the principal protein of eggs, is present in the egg white. Skinprick and intradermal testing with propofol and with its lipid vehicle (Intralipid) were negative in 25 patients with documented egg allergy (74). The measles-mumps-rubella vaccine does contain small amounts of egg-related antigens (ovalbumin), which are grown in cultures of chick-embryo fibroblasts. However, the measles-mumps-rubella vaccine has been given to egg-allergic children without any episodes of anaphylaxis (75). Therefore, current evidence suggests that egg-allergic patients are not more likely to develop anaphylaxis when exposed to propofol.
As is often the case, the science of medicine does not always correlate with the practice of medicine. Dr. Goroza surveyed the SPS listserve and the results of that survey are listed below.
Dr. Goroza’s Survey
Of the 11 responders, only 3 would still give propofol & only if there was no prior reaction to the drug. The majority of the responders would not give propofol and would instead use (some would use more than one method): barbiturates (3 responses), dexmedetomidine alone (3), dexmedetomidine with ketamine (2), benzodiazepine (2), barbiturate with opioid (1) and ketamine alone(1).
It is interesting to note that there is very little published literature describing this topic. I was able to find the two below:
- De Leon-Casasola et al. Anaphylaxis due to propofol. Anesthesiology. 77:384-386,1992.
- Hofer. Possible anaphylaxis after propofol in a child with food allergy. Annals of Pharmacotherapy. 37(3):398-401, 2003.
It seems agreeable that the choice of not using propofol in these situations is driven by concerns over liability. The association is perhaps rare that I have yet to meet an anesthesiologist who has seen one.
What would you do?
Please leave a reply below and tell us how you would handle this situation.