The guideline’s staffing requirements for the presence of at least one medical or dental practitioner during the sedation do not take into account the widespread use of nurse-led sedations using nitrous oxide in major centers and elsewhere in Australia and New Zealand. In multiple large Australian series [8–10], nitrous oxide has been provided safely by sedation-trained nurses when embedded into comprehensive sedation education and credentialing programs.

An agent frequently used by non-anesthesiologists for parenteral sedation is ketamine. Even though it is one of the most frequently used agents in some settings in Australia and New Zealand, particularly in emergency departments [11], the agent is not addressed in the ANZCA guideline. Ketamine, while technically a general anesthetic, provides dissociative sedation and profound analgesia with a very different profile of effect on the cardiovascular and respiratory systems as well as maintenance of muscle tone compared with other general anesthetic agents. Standard definitions of sedation depth such as used in the ANZCA guideline do not apply to ketamine sedation [12]. Furthermore, it has been shown to be a very safe agent in the hands of non-anesthesiologists [13, 14].

Nitrous oxide in the guideline is listed as a method for providing “very light conscious sedation.” This is very true of nitrous oxide titrated slowly from minimum concentrations, maintaining patient cooperation, as is done for minor procedures, especially dental procedures, commonly in association with local anesthesia. It is important to note that, based on the minimum oxygen concentration of 30 % noted in the ANZCA guideline, up to 70 % nitrous oxide can be administered. While generally very safe, nitrous oxide, especially at 70 %, can lead to deep sedation, and providers need to be aware of and be prepared for this [8, 15]. Combining other systemic sedatives or analgesics can be clinically useful but increases the likelihood of deeper sedation and some complications. Recently, nitrous oxide has been combined with intranasal fentanyl, improving the analgesic efficacy of nitrous oxide for non-parenteral sedation in painful procedures. This combination, while now widely used in some settings in Australia and New Zealand for painful procedures such as fracture reductions [16], may be associated with a much higher rate of emesis and a deeper level of sedation [17].

The ANZCA Joint Guideline recommends that medical and dental practitioners receive 3 months of anesthetic training in order to provide sedation. While there are no statistics available for non-anesthesiologists who fulfill these criteria, non-anesthesia colleges for dentistry, radiology, surgery, emergency medicine, and pediatrics do not require such training. Anecdotally, only a minority of trainees from colleges that endorse these guidelines will fulfill this recommendation.

The RACP has published two evidence-based guidelines on the management of procedure-related pain in neonates [3] and in children and adolescents [2].

The RACP guideline statement Management of Procedure–Related Pain in Neonates addresses the following issues: consequences of newborn pain, responses of infants to pain, general principles for the prevention and management of pain in newborns, assessment of pain in neonates, and evidence and suggested techniques. The intent of the guideline was to encourage increased use of analgesia for newborn infants undergoing procedures, including those in neonatal intensive care units. While the guideline does not address procedural sedation in detail, procedural sedation/anesthesia is recommended for endotracheal intubation and for consideration in infants undergoing chest tube insertion and laser therapy for retinopathy of prematurity [3].

The RACP guideline statement Management of Procedure–Related Pain in Children and Adolescents [2] includes sections on sedation for procedures but provides a broader—where possible evidence-based—canvas to improve procedural care in an integrated approach of pharmacological and non-pharmacological techniques to address the problems of procedural pain, anxiety, and behavioral distress in children. An executive summary provides a list of key principles to minimize pain and suffering in procedures as listed in Table 24.1.

After a brief background, definitions and methodology for the literature review are undertaken. The RACP guideline addresses the following issues: pre-procedural preparation with evaluation of the patient, informed consent, and role of the parent; resources required including environment, personnel, equipment, monitoring, and documentation; and procedure, including suggested techniques for commonly performed procedures. Children with communication and behavior problems and those who require repeat procedures are addressed in separate sections. A unique section presents a consumer’s perspective, such as from a mother of a 4-year-old girl who had undergone repeated painful procedures. Appendices address non-pharmacological techniques for procedural pain management, use of local anesthetics, and three sedatives: nitrous oxide, midazolam, and ketamine.

The definition of sedation lists three different definitions by the American Academy of Pediatrics [18, 19], the ASA [20], and the American College of Emergency Physicians [21]. The ASA classification system is used as part of pre-procedural risk assessment. Pre-procedural fasting is discussed critically with a consideration of risk and benefit by weighing up the risk of vomiting and aspiration with the urgency of the procedure. No specific fasting times are recommended. The guideline recommends that informed consent is obtained and documented in the medical record. Without clear evidence regarding the appropriate number of staff required to perform safe procedural sedation, the guidelines make recommendations on staffing based on consensus opinion: “a number of international and local protocols recommend one medical staff member…” should be responsible for monitoring the airway and the patient’s clinical status (the “sedationist”) with an additional staff member performing the procedure. The guideline cites that similar to the ANZCA guideline, it is recognized that some situations may warrant additional staff members. While the RACP guideline does not recommend training or specialty of staff members undertaking sedation, it recommends that those undertaking sedation have knowledge and experience in the use of the techniques being utilized: an ability to monitor clinical effectiveness and possible deterioration, ability to manage adverse events, and to be skilled in advanced airway management.

Resuscitation equipment is recommended to be available where the sedation and procedure are occurring. Non-pharmacological techniques are also recommended to minimize pain and distress. Monitoring should include pulse oximetry (recognizing the limits of this modality to detect hypoventilation and hypercarbia) and capnography (particularly when the patient’s respiratory efforts are not able to be visualized). When administering nitrous oxide, ketamine, and midazolam, it is recommended that the sedationist should be separate from the proceduralist. For nitrous oxide administration, an anesthesiologist is recommended for children under 12 months of age, in cases of preexisting airway problems, or for patients who have received adjuvant sedatives. As with the ANZCA guideline, when using nitrous oxide, a separate means of delivering 100 % oxygen and a system for scavenging of expired gas are recommended. For ketamine and midazolam, practitioners are recommended to be specifically trained in their administration and possess advanced airway management skills.

The RACP guideline emphasizes consideration of the total procedure process including non-pharmacological pain management at all stages of the procedure (Table 24.2) and the provision of a psychologically supportive environment including the use of appropriate language.

The guidelines are unique in that they present evidence and suggested techniques for 23 commonly undertaken procedures: capillary sampling, intramuscular injections, suprapubic aspiration, central venous port access, venepuncture, intravenous cannulation, arterial puncture, intra-arterial cannulation, central venous line insertion, nasogastric tube insertion, orogastric tube insertion, endotracheal intubation, endotracheal suction, chest tube insertion or removal, urethral catheterization, laceration repair, fracture manipulation, foreign body removal, burns and other wound dressing, lumbar puncture, bone marrow aspiration, joint aspiration and/or injection, renal biopsy, and radiological imaging.

For a number of procedures (bone marrow aspiration, joint aspiration, and renal biopsy) conscious sedation or general anesthesia is recommended as first choice in children less than 12 years of age and for adolescents, based on their psychological coping skills, preparation level, and patient/family choice. Nitrous oxide is suggested as a safe and efficacious technique for peripheral and central vascular access procedures, urethral catheterization, laceration repair, burn dressings, lumbar punctures, bone marrow aspiration and joint aspiration, and renal biopsy. Chloral hydrate is suggested for sedation for computed tomography (CT) and magnetic resonance imaging (MRI) scans in infants >3 months and toddlers. Sedation with midazolam or ketamine is recommended for consideration for central venous line insertion, complex laceration repair, fracture reduction, bone marrow and joint aspiration, and renal biopsy. Sedation or general anesthesia is recommended for consideration for CT or MRI scans in children with preexisting behavior problems, for procedures with breath-holding requirements, and in children unable to lie still or who are anxious. The guideline emphasizes that fracture manipulation is highly painful and in many settings manipulation is performed under anesthesia in the operating room. However, in centers with expertise in procedural sedation and analgesia, fracture manipulation is often performed outside the operating room. In such instances the RACP guideline recommends ketamine and ketamine/midazolam. Propofol/fentanyl is not recommended due to the much higher incidence of airway complications. In cooperative older children, with specialized equipment and experienced staff, intravenous regional anesthesia (Bier’s block) is also recommended. Nitrous oxide is recommended for consideration in fracture manipulation in children with minimally displaced fractures.

The RACP guideline addresses the needs of children who require repeat procedures and for those with communication or behavior problems. The guideline groups the latter children into four categories and provides specific suggestions and recommendations for procedural interventions. For children with impaired cognition and inability to communicate, the key recommendations are to explore their means of communication, err on the side of over-treating, and integrate pharmacological and non-pharmacological techniques. The guideline recognizes that comorbidities may contraindicate conscious sedation by the non-anesthesiologist. For children with physical disability and preserved cognition, the key recommendation is to establish how best to communicate with the child. For children with behavioral problems related to preexisting disorders of inattention and hyperactivity, the recommendation is to have a low threshold for pharmacological intervention. For children with procedure-related behavior problems, the recommendations include systematic desensitization, cognitive behavioral therapy, and coping strategies.

The appendices of the RACP guideline include more detailed information on three sedative agents: nitrous oxide, midazolam, and ketamine. The use of demand valve fixed 50 % nitrous oxide and 50 % oxygen as well as continuous flow nitrous oxide up to 70 % is discussed, requiring a circuit for both to scavenge exhaled gas. A minimum 2 h NPO is recommended as a prerequisite if nitrous oxide above 50 % is used. After discontinuing nitrous oxide, 100 % oxygen is recommended for 2–3 min to avoid diffusion hypoxia. For those patients at risk of B₁₂ inactivation (preexisting vitamin B₁₂ or folate deficiency, preexisting bone marrow suppression, severe sepsis, and extensive tissue damage) who receive nitrous oxide frequently for 2 weeks or more, two protocols to minimize vitamin B₁₂ deficiency due to the metabolic effects of nitrous oxide are recommended.

In summary, there is little overlap between the RACP guideline and the ANZCA guideline, although there are shared members of each college. Application of the RACP guidelines suggests appropriate use of non-pharmacological techniques and local analgesia for children. The ANZCA guideline addresses sedation in relation to procedures at any age group. There is no specific consideration of pediatric issues nor of overall procedural management. The ANZCA guideline focuses on the delivery of sedation compared to the RACP guidelines, which attempt to take a more holistic approach. A limitation of the RACP guidelines is that since 2006, when the guideline was published, a number of overseas guidelines referenced have been revised or updated and new evidence has become available.

While major Australian and New Zealand procedural sedation guidelines [1, 2] are available, and key overseas guidelines are in use as well, there is limited knowledge in how far these guidelines and recommendations are used “on the shop floor.” A review in 2004 of the spectrum and the quality of procedural sedation performed by non-anesthesiologist staff outside the intensive care unit at Royal Children’s Hospital in Melbourne, a large Australian tertiary pediatric hospital, indicated some problematic practices [22]. Sedations were tracked prospectively twice daily through hospital walk-through by the authors. One hundred and twenty sedations took place over a 3-week period, for 24 indications, utilizing eight agents in 26 different locations. Neither medical nor nursing staff were present during 7 % of the sedation and during 23 % of the recovery periods. Formal monitoring of vital signs occurred in only 72 %. Fasting practice was highly variable, few sedations used non-pharmacological techniques, and some children were restrained.

A good overview of the challenges involved in minimizing pain and distress in children across initially a ward and then an entire hospital is well described in two papers outlining the experience of a single pediatric service in the United States [23, 24]. The 1997 paper describes the initial few years of a program designed for a pediatric ward in a general hospital. The key principles were to bring uniformity to pain management, sedation, and pain assessment (by the introduction of guidelines/protocols), with particular emphasis on the importance of appropriate topical anesthesia for procedures involving “needle sticks” and the need to involve the child’s parents. The second paper, from 2008, reviews the progress of the program, which was then applied to an entire children’s hospital and not confined to ward activities. The importance of ensuring that all areas of the hospital minimize distress and pain was clearly identified as the program was named “Comfort Central.” The aims addressed the culture of the organization: the physical environment, education, governance, audit and quality processes, matching clinical services to need, collaborating across departments, and involving the patients and families in the process. These principles mirror the concepts summarized in the RACP 2006 Guidelines [2].

At Royal Children’s Hospital, Melbourne, the findings of the audit described earlier in this chapter [22] have led to profound hospital-wide changes in sedation practice: the abolishment of unmonitored or technician-only sedation and the concentration of sedation in a few central locations away from low frequency or remote locations. Hospital-wide sedation guidelines, sedation education, and sedation documentation were implemented across the whole hospital.

Departmental and hospital-wide sedation guidelines have been implemented across many Australian and New Zealand institutions. Sedation care is still often highly variable between hospitals and between departments within the same institution. Regulatory authorities do not mandate a standard accreditation or training process for sedation providers. There is no requirement to standardize sedation care throughout an institution as has been mandated in the United States by the Joint Commission [4].

A number of relatively large series from Australia and New Zealand have shown that pediatric sedation by non-anesthesiologists can be performed safely when embedded in local sedation education programs [9, 10]. However, even among tertiary pediatric institutions, few have hospital-wide sedation education programs. While there are no national sedation education programs nor education conferences that exist in the United States, departments at larger pediatric tertiary hospitals often provide education or education materials for non-tertiary institutions who conduct pediatric sedation. For example, a validated sedation education program from Royal Children’s Hospital and Sunshine Hospital in Melbourne [25, 26] has been adopted by the state health department and rolled out statewide in the state of Victoria [27]. This program includes central education sessions, sedation education materials, and a standardized sedation record.

Only one tertiary children’s hospital in Australia provides a formal “sedation service” run by anesthesiology staff. At a few centers, nurse-led sedation with nitrous oxide is provided hospital-wide. At most centers, sedation is delivered by anesthesiologists, except for some subspecialties such as dentistry or emergency medicine.