Pain and fear of pain cause a great part of the suffering experienced by children when they visit a health care facility. Both may be present in the child on arrival to the facility, or may be caused or elicited by the diagnostic or therapeutic procedures required by the patient.1,2

Pain must be managed safely and effectively, regardless of age, maturity or severity of disease for physiological, moral, humane and ethical reasons.3–5 Furthermore, it is known that untreated pain has physiological and psychological consequences, increasing the pain associated with future procedures.6

Until recent years, the management of pain and anxiety in children was one of the most neglected aspects of care in paediatric emergency departments (PEDs) due to the very nature of emergency care, in which time is a critical factor.7 However, in the past few years there has been a growing interest among paediatric emergency physicians in providing adequate sedation and analgesia (SA) to their patients.2

Today, the need for sedation and analgesia is considered indisputable. It is also understood that the correct management of SA and patient safety during its administration require not only the identification of the need for SA, but also adequate training of the staff that delivers SA to minimise and correctly address its risks.3,4 Thus, adequate staff training and protocol development are crucial to the safety of paediatric patients.4

In 2009, the Working Group on Analgesia and Sedation of the Sociedad Española de Urgencias de Pediatría (Spanish Society of Paediatric Emergency Medicine [SEUP]) developed the first manual on analgesia and sedation in the paediatric emergency setting, followed by the introduction in 2015 of a nationwide register of SA procedures performed in Spanish PEDs.

The aim of our study was to analyse the preparation of SA procedures in 18 PEDs in Spain, and to find out the characteristics of the patients that underwent these procedures.

A total of 658 SA procedures were registered between February 1, 2015 and January 31, 2016, of which 404 (61%) were performed in male patients. The mean patient age was 6.6 years (SD, 4 years), and 592 children (90.7%) were aged more than 2 years.

Out of all SA procedures, 69% were performed on weekdays. Also, 311 (47.9%) were performed in the afternoon, 254 (38.6%) in the morning and 89 (13.5%) at night.

Table 2 summarises the characteristics of the evaluation prior to SA performed in the children included in the study. We ought to note that 6 of the included patients were classified as ASA III, and that 4 of them were managed by paediatric emergency physicians with appropriate training for performing SA procedures in this type of patient.

The duration of fasting was assessed in 538 children (81%). Fasting time was less than 2h in 50.9% of children that underwent simple analgesia, 46.2% of children that underwent sedation, 31.6% of children that received SA for a very painful procedure and 25.5% of children that received SA for mildly painful procedures, and the difference was only statistically significant between the simple analgesia group and the SA for mildly painful procedures group (p<.01).

Anticipatory anxiety was assessed in 608 children (92%). When it came to patient age, and excluding the subset of patients that experienced panic, we observed that anticipatory anxiety increased with decreasing age, although the correlation was weak (rho, 0.18; p<.01).

Fig. 1 summarises the reasons for use of SA, the type of SA procedures performed, and the type of professional that carried out the procedures.

Figure 1.

Professional delivering SA, reason for SA and type of SA procedure.

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Table 3 summarises the most frequent reasons that led to the use of SA in our study.

We analysed the type of SA used based on the type of professional that delivered it and found that paediatric emergency physicians and third- and fourth-year paediatrics residents used SA for mildly or very painful procedures more frequently than nurses or first-year paediatrics residents, who were more likely to use simple analgesia and sedation (p<.01).

Informed consent for performance of SA was requested in 649 (98.6%) procedures; it was obtained in writing in 444 cases (67.5%) and verbally in the remaining 205 (31.2%).

We analysed whether consent was obtained in writing or verbally based on the type of SA procedure to be performed, and found that consent was obtained in writing more frequently for SA for very painful procedures (76.6%) compared to SA for mildly painful procedures or simple analgesia (62.9% and 54.4%, respectively; p<.001).

The pharmacological strategy consisted in the administration of a single drug in 443 of cases (67.3%) and of a combination of drugs in 215 (32.7%) (Table 4).

Table 5 shows the mean age of the patients for each pharmacological strategy. We found that the combination of nitrous oxide and fentanyl was used more frequently in older children (9.34 years) compared to the combination of midazolam and ketamine (5.51 years) or of midazolam and fentanyl (4.1 years), differences that were statistically significant (p<.001).

In 258 SA procedures (39%), a topical or local analgesic was added to the administration of systemic drugs (lidocaine/prilocaine in 16.7%, lidocaine-adrenaline-tetracaine [LAT] gel in 2.9% and local anaesthesia in 15.8%).

Monitoring was used in 480 children (73%), in most cases by pulse oximetry (95.8%). In addition, 95 patients (19.5%) underwent heart rate continuous ECG monitoring of the heart rate, 127 (26.4%) intermittent blood pressure measurements, and 21 (3.2%) monitoring of carbon dioxide partial pressure via nasal cannulae.

We assessed the potential association of monitoring and the type of SA procedure and found that monitoring was less frequent in simple analgesia procedures (19%) compared to the rest (87% of sedation procedures, 70% of SA for mildly painful procedures and 87% of SA in very painful procedures; p<.001).

The parents of 352 patients (53.5%) were present during the procedure, and their presence was more frequent in nursing procedures (80%) and surgical procedures (69%) compared to all other procedures in which SA was used (p<.01).

The presence of parents in relation to the type of SA procedure was more frequent in children that received simple analgesics (73%) or SA for less painful procedures (68%) compared to the rest of SA procedures (40% of patients that underwent sedation and 38% of patients that underwent SA for very painful procedures; p<.01) (Fig. 2).

Figure 2.

Parental presence by type of SA procedure.

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We also observed that parental presence decreased the more pain the child expressed before the procedure (p=.09) and the deeper the target level of sedation (p<.01).

The length of stay in the emergency department was less than 1h in 125 procedures (19%), 1–2h in 359 (54.6%) and more than 3h in 154 (23.4%). We observed that the stay in the PED was longer (>3h) in patients that underwent sedation (34.6%) or when SA was used for mildly painful procedures (34.9%) compared to the rest of SA procedures (1.7% of patients that received simple analgesia and 16% of patients that received SA for very painful procedures; p<.01).

The discharge destination was the home in 71.9% of patients (473), while the other 28.1% (175) required hospital admission; adverse reactions to SA were the reason for admission in only 3 patients (1.7%). In these cases, the main adverse effect was dizziness associated with vomiting, requiring a 24-h stay in the paediatric ward. We observed that patients that underwent SA for mildly painful procedures were admitted more frequently than patients that underwent SA for very painful procedures (38.5% vs 15.2%; p<.01).

The purpose of procedural SA is to allow the patient to tolerate painful or unpleasant procedures while maintaining airway reflexes, ventilation and cardiovascular function.1 The guidelines of the American Academy of Pediatrics3 and the American Society of Anesthesiologists5 consider the use of procedural SA safe and appropriate for the management of pain and anxiety resulting from diagnostic and therapeutic procedures and methods. In addition, the prevention and alleviation of pain during diagnosis and treatment is a health care quality indicator in PEDs.4

The correct preparation of SA procedures is essential for their success, and protocols must be established to guarantee a correct and detailed evaluation of patients prior to any SA procedure.1,2,4 The use of checklists to apply specific guidelines can help prepare for SA procedures correctly and minimise potential adverse effects.11

As has been the case in previous studies,12,13 we observed that most paediatric patients were healthy individuals that were not receiving chronic medication and with normal findings on physical examination. According to the American Society of Anesthesiologists, only patients classified as ASA I or II3,5 can be considered candidates for receiving SA from non-anaesthesiologists. In our study, 6 patients were classified as ASA III, and 4 were managed by paediatric emergency physicians with adequate training, a parameter that needs improving, as 2 of these patients were managed incorrectly.

The ASA recommends taking certain precautions prior to SA. It recommends preprocedural fasting in patients undergoing elective procedures to reduce the risk of bronchoaspiration, and does not consider absence of fasting a contraindication in urgent procedures, while recommending an individualised risk-benefit assessment in all other cases.14

To date, several studies have been conducted that failed to establish an association between the incidence of adverse effects and the duration of fasting.15–19 In our study, the duration of fasting had been documented in most patients, however, we found considerable heterogeneity in this variable.

Sedation and analgesia must be considered a medical intervention apart from, and not part of, diagnostic procedures.2,3 Therefore, informed consent must be obtained separately before performing any SA procedures. In our study, informed consent was sought in almost every instance, although it was obtained in writing in only 2/3 of the patients. Whether consent was obtained in writing or verbally varied based on the type of procedure, as written consent was sought more frequently in SA procedures associated with a higher risk of complications, such as sedation or SA for very painful procedures. We did not find similar studies in the reviewed literature analysing how informed consent was obtained.

The pharmacological strategies selected for SA depend on the level of anxiety and pain that may be associated with the procedure.2,20 Drug selection requires a thorough knowledge of the pharmacodynamics, therapeutic effect, dosage and potential adverse effects of the different sedatives and analgesic agents, and providers must unfailingly avoid underdosing for fear of respiratory depression or out of a lack of familiarity with these drugs.4,20

In our study, nitrous oxide was used in nearly half of the procedures. This is an extensively studied drug that is easy to use and associated with few serious adverse effects.21,22 When it came to the combined use of drugs, the most frequent combination was midazolam and ketamine, drugs that are recommended for SA in children1,23 and which have been used frequently in similar studies.24

The use of local or topical anaesthesia in addition to systemic drugs is recommended to reduce pain in some techniques or procedures.23–25 There are numerous topical anaesthetic agents whose administration is not painful, such as lidocaine/prilocaine for intact skin and LAT gel for wounds.25 In our study, a topical or local anaesthetic was used in one third of the patients, most frequently a lidocaine/prilocaine anaesthetic cream.

Monitoring of vital signs is necessary to detect potential adverse effects as soon as possible.2,26 In our study, nearly 3/4 of the children were monitored, and the most frequently used monitoring technique was pulse oximetry, which was consistent with the findings of similar studies.23,24 It seems that most paediatricians are familiar with pulse oximeters, which may be the reason that this technique is used most frequently. Capnography is another method that provides thorough information on the respiratory pattern and the ventilatory status of the patient, and it can detect hypoventilation earlier than other methods; it is a particularly useful approach when providers do not have visual contact with the patient during the procedure.27 In our study, capnography was used in 21 patients (3.2%), probably due to its low availability in PEDs or to physicians not being well acquainted with this technique.

The use of nonpharmacological interventions for the management of anxiety and pain in paediatric patients is also important.9,23,28–30 The presence of the parents during procedures is becoming increasingly important, as it is consistent with the current patient- and family-centred approach to health care delivery.31,32 This strategy is not yet implemented in every PED or by all professionals with the justification that the presence of the family may add to the stress of health care providers and hinder the success of the procedure.32 However, this is not the case when procedures are carried out by experienced paediatricians.33 In our study, family members were present in a little over half of the procedures, and it is worth noting that the more pain the child expressed prior to the intervention, the less likely it was for parents to be present during the procedure. This suggests that not all providers in paediatric emergency settings feel confident in performing procedural SA, something that has already been described in similar studies.6,28

One of the limitations of our study is that although it was conducted in multiple centres, it was not representative of all of Spain, since several autonomous communities were not represented in the sample. Hospitals were randomly included in the study and the sampling method did not include stratification by autonomous community. Another potential limitation is that we do not know whether participating hospitals had protocols for SA at the time of the study, and therefore were unable to determine whether SA procedures were or not performed according to existing guidelines.

We would like to conclude by noting that most of the SA procedures analysed in this study were prepared correctly and in adherence with the recommendations of the American Society of Anesthesiologists and the guidelines of the American Academy of Paediatrics.

The authors have no conflicts of interest to declare.