Anesthesiologists throughout the world have been concerned about sedation by the untrained and have published guidelines to prevent patient harm. (Refer to Chap. 2.) Excluding dentistry, United Kingdom guidelines for doctors focused first on the radiology setting [52]. In 2001 the Academy of Medical Colleges responded to reports of unacceptable mortality in adult patients having esophagogastroscopy [53]. They stated clearly that “organizations should ensure that staff receives sedation training.” To date, there are no universal guidelines to encompass all of Europe.

The Scottish Intercollegiate Guidelines Network (SIGN) [54] gathered a body of opinion from across many specialties and developed a clinical guideline that has been quoted and used widely. The SIGN guideline was limited to moderate sedation. In 2010 NICE issued a comprehensive guideline specifically for children and young people, and it incorporated guidance for all forms of sedation including deep sedation [55]. In Italy, a review and guideline was produced for pediatric neuroradiology [56]. A European guideline for PSA in adults has been published [57]. Evidence-based national guidelines are now available in the United Kingdom, the Netherlands, Germany, and France.

In a survey we recently performed among about 100 participants of symposia on procedural sedation during two recent European conferences (PREM, Ghent May 2013; ISSP, Stockholm June 2013), the vast majority was not aware of any national or European guidelines. The lack of an appropriate, well-tailored program for guideline awareness and implementation is likely to be an important factor in this ignorance. The European Society of Anesthesiology (ESA), the European Society for Pediatric Anesthesiology (ESPA), the Association of Paediatric Anaesthetists (APA), the Royal College of Paediatrics and Child Health, the European Academy of Pediatric Societies (EAPS), the European Pediatric Association (EPA), and the European Society for Pediatric Research (ESPR) are not involved in setting up, training, or implementing appropriate training for PSA by non-anesthesiologists.

We believe that had any of the available guidelines been applied, the aforementioned disasters would not have happened [58]. Although these guidelines may have already prevented many catastrophes, in the authors’ opinion they would benefit from endorsement and dissemination by the national and European specialty organizations.

Ethical and legal considerations become increasingly important in European pediatric health care. In children undergoing a medical procedure, professionals must weigh the need to perform that procedure against the child’s wishes to be left untouched. Most importantly, if the knowledge and technology to perform sedation/analgesia for this procedure easily and painlessly exists, one cannot justify merely restraining a terrified child for a painful procedure because of the cost or extra efforts involved.

Current European legislations usually hold that a young child (defined as <12 years in Dutch legislation; defined as below the developmental age of reasonable comprehension in most other European countries) is not autonomous—that is, he/she is not at liberty to refuse needed treatment, as long as informed consent is obtained from parents or caregivers. This reasoning is probably unhelpful and may be a misreading of the law. It has been postulated that only if society ultimately considers physical restraint to accomplish a medical procedure a violation of a child’s civil liberty—which is, for example, the case in Scotland—we will all become more committed to alternative solutions such as PSA [59]. Medical professionals should help parents and children understand the nature of a given procedure and the possible options for altering perception of that procedure—be they emotional support, hypnosis, distraction techniques, anxiolytic/analgesic medications, or general anesthesia. Perhaps most importantly, the consideration of these ethical principles requires providers to reconsider alternative plans for sedation of each child: Physical immobilization or restraint cannot be a surrogate to sedation. Fear of potentially unsafe deep sedation is important but must be counterbalanced with the risk of unwanted emotional and psychological injury. Horrific accounts of painful procedures without effective PSA have been linked to post-traumatic stress disorder [6, 59–61].

Recent jurisprudence in the Netherlands shows that a care provider who does not allow sufficient time and effort to adopt a suitable approach to a resisting child may have to face negative consequences: Courts may rule that a defensive (panic) response from children resulting in injuries to the care provider is not unlawful. In these cases, any claim for damages against the parent(s) would fail [62]. Seen from the child’s perspective, it could furthermore be argued that the child has a right to oppose a medical treatment, at least within certain specific boundaries.

Alternatively, the ethical principle “first do no harm” and the basic right for optimal care require the PSA practice to be optimally safe at all occasions. The potential toxicity of PSA drugs needs to be excluded. To this end, the recent concerns on the possible neurotoxicity of anesthetics on the developing brain may be relevant [63]. Although clinical relevance has not been substantiated, results to date indicate that exposure of animals to general anesthesia during active synaptogenesis is most detrimental [64]. Given the recent trend to administer ketamine and propofol for PSA, these observations may be relevant. Currently it is not known whether the experimental findings in animals can be simply extrapolated to human beings in general and to PSA in children in particular. Furthermore, the eventual (neuro)toxicity of non-anesthetics such as barbiturates, benzodiazepines, and chloral hydrate has never been subject of systematic research. The potential toxicity of potent PSA drugs must be counterbalanced with the potential biological and psychological consequences of ineffective sedation and repeatedly painful or distressing experiences during childhood [65]. Additional research is needed and in progress in order to clarify this dilemma.

Conscious sedation was an accepted endpoint or landmark in the continuum of conscious level. Conscious, meaning “able to respond to the spoken word,” has been replaced by the term moderate sedation in the current literature because it does not assume consciousness but rather that the patient is easily roused—usually by communication but also by other similar appropriate light stimulus [66]. Nevertheless, conscious sedation remains a common term in Europe [52, 67]. In the United Kingdom, dentists prefer the term conscious sedation, referring to a level of sedation at which the patient responds easily to commands.

The term deep sedation is not approved [52] in some European professional groups, because it is possibly indistinguishable from anesthesia. This has led to the recommendation that both deep sedation and anesthesia should be managed with the same standard of care with respect to monitoring, equipment, facilities—and trained personnel. The definition therefore is more a description of the intended level of consciousness rather than a threshold identifying resources or risk. In a similar desire, two other descriptions of deep sedation/anesthesia have been used: Light anesthesia [68] and minimal anesthesia [69] are terms that describe a patient who is arousable with any appreciable stimulation. Techniques involving minimal anesthesia with propofol or sevoflurane have been used [70] for painless imaging.

Dissociative sedation is not a term in common use, but it is understood. Ketamine sedation or anesthesia is preferred generally.

Relative analgesia (RA) is a term intended to describe the analgesia and mild euphoria and calming properties of 30 % nitrous oxide. Dentists have become expert in its use [71].

The more relevant question is whether these definitions are useful. Although they may help identify sedation depths with drugs that are titratable, what is their value for non-titratable drugs? Motas et al. showed that common drugs (e.g., chloral hydrate, midazolam, pentobarbital) in average doses cause wide variations in depth of sedation [72]. The goal of achieving conscious or deep sedation was unable to be achieved in a significant number of children. With these findings in mind, the Dutch working group on procedural sedation decided to recommend the same safety precautions for all levels beyond light sedation.

With the exception of dental sedation, there are no European training programs or specific qualifications for administering sedation. An Italian multicenter research group has reported the successful outcome of a strict training program for non-anesthesiologists who deliver propofol sedation to children [33, 39]. In the Netherlands, a national multidisciplinary training program (including the involvement of pediatric anesthesiologists) is currently being set up as to implement the PSA guidelines. In a first phase, participants will learn to perform light sedation (transmucosal midazolam, 50 % nitrous oxide inhalation), topical anesthesia, and hypnosis-like techniques. They will then progress to organize or manage procedures that require deep sedation (e.g., by setting up centralization or referral to anesthetists). The second phase is intended to give sedation providers sufficient exposure to become fully trained in deep sedation.

In the United Kingdom, an independent expert group has made recommendations on the training for pediatric dental sedation [73]. A challenge, however, is how to provide trainees with sufficient exposure to different, rarely used sedation techniques.

It is difficult to design a universal training curriculum for the many different types of sedation, some of which will not be relevant for all specialists. Strategies for credentialing have been clearly identified by Krauss and Green [74]. The authors of this chapter favor the option of creating a safe and effective sedation service that is controlled by the institution under direction from national and professional guidelines. Such a system will develop efficient training programs that may evolve into national training curricula.

All sedationists should have skills in airway management and resuscitation. Access to live patients is a limiting factor and the development of life-like manikins is a potential solution. (Refer to Chap. 35.) European resuscitation courses are widespread but do not aim to teach the monitoring and proactive airway skills that are critical for sedation providers. These skills should be an integral component of specialty-specific sedation training courses.

European standards of practice are mainly enforced by professionals themselves, and, unlike the United States, there are no financial penalties imposed by insurance companies. In the United Kingdom, clinical governance is a term applied in the National Health Service (NHS) to force individuals to bear responsibility and accountability for their actions. This governance has helped to improve quality and safety. In the United Kingdom and in the Netherlands, compulsory annual appraisal, and revalidation every 5 years, should motivate doctors and dentists to maintain their practice, skills, and knowledge. Failure to revalidate removes their license to practice.

Guidelines are designed to improve professional performance, health-care process, outcomes, and costs. However, the designing, publishing, and dissemination of guidelines do not necessarily imply the intended positive change in daily practice [75]. Guideline recommendations can be directed at a heterogeneous population of professionals with different backgrounds, experience, knowledge, skills, opinions, and motivational beliefs (i.e., positive and negative perceptions, evaluations, and expectations). This bewildering heterogeneity of factors must be reconciled, as illustrated in a recent study [76]. Since all these factors separately may act as both facilitators and barriers for guideline implementation, a thorough assessment of their interactive effects is critical in the design and implementation strategy. In the Netherlands, and elsewhere, the implementation of guidelines on PSA has been encouraged by raising public awareness through media and charities.

How willing are society, health-care authorities, and insurance companies to invest in improving PSA? Given the current global financial crisis, it will be essential to demonstrate that implementing a guideline saves money. Probably, the “burden” of necessary investments to achieve more effective PSA services (e.g., training, new professionals, accessibility of propofol and nitrous oxide, appropriate monitoring and recovery, timely availability on a 24-h basis) can be quite easily calculated and will create immediately strong barriers for change. Calculating the economic aspects of the benefits will be much harder, balancing the costs of the improvements against the costs of unsafe practice and ineffectiveness.

A few studies on pediatric PSA have identified economical costs as an outcome measure. In the 1990s, Kain et al. compared propofol-based procedural sedation with intravenous thiopental/pentobarbital sedation for children undergoing MRI. A preliminary cost analysis was applied to the clinical data obtained and to a theoretical model of a pediatric MRI center. Cost analysis of the propofol-based services revealed an added drug cost ($1,600.76 per year for the propofol group) but a significant savings in post-sedation care unit (PACU) nursing time ($5,086.67 per year) [77]. Ekbom et al. published a randomized controlled study in children with difficulties in establishing venous access or anxious children in need for an IV access. The patients were randomized to conventional treatment—i.e., cutaneous application of Eutectic Mixture of Local Anesthetics (EMLA)—or nitrous oxide treatment. They concluded “the pre-treatment with nitrous oxide is a time effective and safe method to reduce pain, facilitate venous cannulation, and thereby reduce the number of costly cancellations of planned procedures” [78].

In 2013 the Dutch Association of Hospitals ordered a business-impact analysis and cost calculation on the implementation of the new Dutch PSA guideline. Their study showed that the implementation of deep sedation services for children undergoing major procedures (e.g., MRI, endoscopy, extensive wound care) in each of the 98 Dutch hospitals (on a total population of 16 million inhabitants) would not be financially effective. Centralization of these services to about 20 institutions would be financially more prudent. However, the same study demonstrated that setting up a 24-h sedation service to provide “light sedation” (e.g., application of nitrous oxide) for minor painful procedures would be cost-effective in all of the 98 Dutch hospitals.

The United Kingdom NICE guideline compared the costs of various sedation techniques and approaches [55]. (Refer to Chap. 2.) The most significant cost involved the salary for staff. This evaluation, however, was limited in its scope and applicability. For example, the comparison was based on a single procedure and did not consider the advantages of improved efficiency if, indeed, anesthesiologists were able to create “turnover” time.