1.1 Background

There is wide variation in the selection criteria and in the techniques used for the preparation, monitoring and management of children requiring sedation for diagnostic and therapeutic procedures. A recent survey of 268 Scottish hospital departments revealed that although sedation of children was undertaken by one in four departments, only three had a protocol for paediatric sedation.¹ This suggests that despite the multiplicity of published guidelines for sedation in both adult and paediatric specialties,^{2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16} these are not being applied consistently in clinical paediatric practice.¹⁷ This guideline was therefore developed, drawing together the existing evidence and following wide consultation. This methodology fosters multidisciplinary ownership and will ensure that this guideline is implemented widely across Scotland.

The practice of sedating children for procedures is often based more on consensus and clinical tradition than on scientific evidence. Even within the body of expert opinion, a review of the literature suggests that practice is often more influenced by available resources (including perceived or actual shortage of paediatric anaesthetic services) than by validated evidence of benefit.

1.2 Remit of the guideline

The guideline seeks to answer three key questions:

• What are the requirements for safe paediatric sedation in terms of patient selection, patient preparation, personnel, monitoring, record keeping and post-procedure care?
• Which sedation techniques are appropriate to achieve safe sedation of children?
• How do these sedation techniques perform in terms of efficacy, adverse effects and safety?

This guideline is applicable to all children under 16 years of age, of normal physical and mental development, undergoing painful or non-painful diagnostic or therapeutic procedures in the hospital, community, general medical or dental practice settings. A guideline for sedation in the dental setting is currently being prepared by the Chief Dental Officer and when that is published, it will supersede the dental guidance in this document.

Specifically excluded from this SIGN guideline are patients who require assisted ventilation, intensive care sedation, premedication for general anaesthesia, postoperative analgesia, sedation in palliative care, sedation in psychiatry, night sedation, and sedation in the home setting.

1.3 Principles of good sedation practice

All sedation techniques carry risk.¹⁸ Good clinical practice suggests that a combination of non-pharmacological and pharmacological methods should be considered to ensure optimal management of the emotional and physical consequences of diagnostic and therapeutic procedures in children. While it may be possible to manage many children undergoing a particular procedure with non-pharmacological techniques, others undergoing the same procedure may require general anaesthesia. Thus an individualised approach is required to minimise fear, anxiety, pain, and distress while at the same time accomplishing the procedure safely, reliably and efficiently and respecting the rights of the child.

The concept of sedation encompasses reduction of fear, anxiety or stress, induction of drowsiness or sleep and provision of pain control, comfort and a sense of well-being. Agents with sedative properties may have varying degrees of effects on consciousness level, anxiety, memory and pain. Anxiety may be best alleviated by good communication, a sympathetic approach and paediatric expertise. Pain should be prevented whenever possible by the pre-emptive use of local and systemic analgesics or alternative measures to reduce pain perception.

1.4 Definations of sedation

Sedation is a continuum from the awake state.¹⁹ The American Society of Anesthesiologists (ASA) uses the following definitions for levels of sedation:¹⁹

Minimal sedation (anxiolysis) is a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected.

Moderate sedation/analgesia (conscious sedation) is a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation (reflex withdrawal from a painful stimulus is not a purposeful response). No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.

Deep sedation/analgesia is a drug-induced depression of consciousness during which patients cannot be easily roused but respond purposefully following repeated or painful stimulation. The ability to maintain ventilatory function independently may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. In the UK, deep sedation is considered to be part of the spectrum of general anaesthesia.²⁰

General anaesthesia is a drug-induced loss of consciousness during which patients are not rousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.

To promote consistency across Scotland, in this guideline sedation means minimal or moderate sedation/analgesia as defined above. When the child does not respond purposefully to verbal commands and/ or light tactile stimulation, the standards of care of that child must be identical to that for general anaesthesia. When using sedation in the primary care or outpatient setting, there should be no intention to progress to either deep sedation or general anaesthesia, even when sedation fails.

1.5 Statement of intent

This guideline is not intended to be construed or to serve as a standard of medical care. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advance and patterns of care evolve. These parameters of practice should be considered guidelines only. Adherence to them will not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultimate judgement regarding a particular clinical procedure or treatment plan must be made by the doctor, following discussion of the options with the patient, in light of the diagnostic and treatment choices available. However, it is advised that significant departures from the national guideline or any local guidelines derived from it should be fully documented in the patient’s case notes at the time the relevant decision is taken.

1.6 Review and updating

This guideline was first issued in February 2002 (as SIGN publication number 58) but was found to contain referencing errors and errors in the assignment of grades to recommendations. This revised guideline (May 2004) corrects these errors but does not consider any recently published evidence and replaces the original guideline. Details about future revisions will be noted on the SIGN website: www.sign.ac.uk