The dilemma and future of pediatric sedation in China

Authors: Li Bo, Zheng Jijian, Zhang Mazhong, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

1.
Definition and indications for sedation in diagnosis and treatment operations

Procedural sedation and analgesia (PSA), often referred to as "diagnostic and surgical sedation" (sometimes referred to as "medium-depth sedation") in China, is the use of anxiolytic, sedative, analgesic or dissociative drugs to reduce pain, anxiety, and physical movements in order to perform clinically necessary diagnostic or therapeutic procedures, while providing an appropriate degree of amnesia or loss of consciousness and ensuring
。

Here we need to emphasize 3 points: (1) The English word "procedural" is often translated as "program", which is a wrong "hard translation" in the words of Mr.
Lu Xun; (2) The term "conscious sedation" used in the early days is misleading and is no longer used clinically; (3) The use of analgesics alone does not fall within the scope
of diagnosis and treatment of sedation.
Since the American Academy of Pediatrics (AAP) issued the first guidelines on pediatric sedation in 1985, a number of professional organizations and associations have issued technical guidelines for pediatric sedation applicable to different diagnostic and treatment procedures, and these guidance documents have been continuously updated over the years, providing a large number of bases and guidance for
the implementation of pediatric sedation work.

Domestic pediatric diagnosis and treatment operation sedation work started relatively late, but in recent years, more and more pediatricians have begun to realize that receiving diagnosis and treatment operations in the case of awake or insufficient sedation can have a negative impact on the psychology of children, so the demand for sedation in domestic children's diagnosis and treatment operations is increasing, and the scope of application is continuously expanded to digestive endoscopy, nasal endoscopy, tracheobronchroscopy, and neurological system diagnostic examination
.

In pediatric patients, sedation-assisted procedures are required, including fracture reduction, abscess drainage, imaging (ultrasound, MRI, CT) and electrocardiogram, bone marrow aspiration, tooth extraction, etc
.

2.
The development and dilemma of sedation in domestic children's diagnosis and treatment operations

Joint Commission International (JCI) is a subsidiary of the Joint Commission on the Accreditation of International Health Care Institutions for the certification of medical institutions outside the United States
.
Shanghai Children's Medical Center (hereinafter referred to as Children's Medical Center) affiliated to Shanghai Jiao Tong University School of Medicine applied in 2007 and passed the certification in December 2010, becoming the first children's hospital
in China to pass JCI accreditation.
Prior to this, the Children's Medical Center began to officially carry out sedation work in China in June 2010, and then the Guangzhou Women and Children's Medical Center also carried out this work, and quickly surpassed
the number of cases served and clinical research.
In just over a decade, the sedation work of pediatric diagnosis and treatment has developed extremely rapidly
in China.

According to the questionnaire survey of children's medical centers, as of the end of 2018, 92.
1% of tertiary women's and children's hospitals and children's specialty hospitals in China have carried out children's diagnosis and treatment operation and sedation
.
However, a series of problems were exposed in the investigation, such as the lack of uniform standards for various hospitals in terms of process settings, evaluation standards
, hardware facilities, and staffing.
In the future, how to incorporate the sedation work of children's diagnosis and treatment operation into the standardized and standardized benign development track is a problem
that every practitioner of diagnosis and treatment operation sedation work needs to think about.

2.
1 Lack of technical guidance tailored to national circumstances

Even in developed countries in Europe and the United States, pediatric sedation technology is far from mature, AAP, ASA, American Academy of Pediatric Dentistry (AAPD), American College of Emergency Physicians (ACEP) and other academic organizations have been updated and improved over the years
。 Among the many problems found through the questionnaire, although there are reasons for the imbalance of regional development, the deeper reason is the lack of technical guidelines
for the operation of sedation in children's diagnosis and treatment that meet the national conditions of our country.
Due to the lack of original clinical studies with extremely high evidence levels and suitable for national conditions, it is not easy
to compile guidelines that are appropriate to national conditions.

It is safe to say that most of the studies conducted in China are poorly designed to provide effective clinical evidence
for the compilation of guidelines.
Therefore, we can only take a back seat and rely on expert consensus to help
.
In addition, the physical space, personnel and equipment configuration of hospitals, types and habits of clinical drugs, the speed of knowledge update, the acquisition and utilization of information technology are quite different from foreign countries, and the cognitive level of medical staff, patients, competent departments and industry associations also needs to be improved
.
In view of this, the relevant guidelines issued abroad are directly used to guide the sedation of domestic children's diagnosis and treatment, and to a certain extent, there is a lack of practical operability
.

However, it must be admitted that a considerable part of the relevant European and American guidelines are of great reference value, but in terms of staffing, qualification certification, fasting regimens, sedative medication, etc.
, the suggestions provided by the European and American guidelines are either not in China or have the conditions for implementation, or are worth exploring
.
Therefore, when formulating the domestic technical guidelines for sedation in children's diagnosis and treatment, it is necessary to demonstrate and modify these contents to conform to the current national conditions of our country, so as to guide the standardization and standardized development of
children's diagnosis and treatment operation and sedation in China.

2.
2 Staffing and Certification

Children's diagnosis and treatment operations and sedation workplaces need to be routinely staffed with volunteers, child psychologists, anesthesiology nurses and physicians, diagnosis and treatment operators, etc.
, with a clear division of labor between them, paying attention to all
aspects of the child's life, psychology and treatment.
Regardless of volunteers and psychologists, there is currently a serious shortage of anesthesiologists in China, and how to efficiently and safely cope with the growing demand for sedation in children under the objective premise of the scarcity of anesthesiologists is a problem
that must be faced at present.
Statistics show that the number of anesthesiologists in China is only about 6/100,000, the number of anesthesiologists in Europe is 18.
6/100,000, and in the United States, the number is 20.
8/100,000
.

While the NHC has identified and begun to address this issue, the training cycle of physicians dictates that it takes a lot of time
.
Under the objective premise that the number of anesthesiologists is insufficient at present, the construction of a sedation work system for diagnosis and treatment operations led by a small number of anesthesiologists and coordinated by multiple auxiliary medical personnel (such as anesthesia nurses, or other medical personnel) is in line with the current national conditions
of our country.

In this system, the anesthesiologist should mainly play a supervisory role, responsible for assessing the child's condition (whether there are contraindications to sedation, whether the criteria for awakening and leaving the hospital are met, etc.
), selecting appropriate sedative drugs, and dealing with possible adverse reactions; Medication and monitoring are left to paramedical staff
.
Anesthesiologists are a key player in the system, so their qualifications should be higher than those of other paramedical staff
.
Due to the issue of medical costs (and possibly other factors), there is a great deal
of debate abroad about whether anesthesiologists should be present to lead the sedation of diagnosis and treatment.
The results of many recent clinical trials of remazoram Phase II and III emphasize that "there was no anesthesiologist involved in this study.
"

European and American guidelines do not clearly define
the leading and/or auxiliary roles in the sedation process of pedagogical procedures.
The more frequently mentioned qualification requirements are that practitioners should have pediatric basic life support (PBLS) and pediatric advanced life support (PALS) capabilities
.
PBLS is often used as a basic competency that must be possessed by practitioners of sedation, and PALS generally does not require all practitioners to have it, but a professional with PALS ability (such as an anesthesiologist) must be present
during deep sedation.

However, considering that the depth of sedation after medication is often not accurately controlled, and the situation that exceeds the expected depth of sedation or even the state of anesthesia occurs from time to time, and most children actually need to perform diagnostic and therapeutic operations under deep sedation conditions, this requirement can be roughly understood as the participation of professionals with PALS ability in the process of pedestalization in
children 。 China's "Pediatric Operating Room Anesthesia / Sedation Expert Consensus" proposes that anesthesiologists responsible for pediatric diagnosis and treatment and sedation should have the qualifications of attending physician or above, and have more than 1 year of experience in pediatric anesthesia operation; Each sedation unit is equipped with more than 1 medical staff who have passed anesthesia/sedation training and PALS training, and cooperate with anesthesiologists to carry out pediatric sedation work
.

Comparing the European and American guidelines, it can be found that the requirements for auxiliary medical personnel in the consensus of experts in China need to go through "anesthesia / sedation training" in addition to PALS
.
The specific training content is not explained by experts, but similar training requirements
can be found in the "Recommendations of the American Association of Anesthesiologists to Authorize Non-anesthesiologists to Implement Deep Sedation" (the "Recommendations") issued by the ASA.
The Recommendation states that, in addition to PALS and/or PBLS training, sedation practitioners are required to perform operational exercises on airway management skills for at least 35 patients (including simulators), including mask ventilation, oropharyngeal ventilation tract and throat masks, and endotracheal intubation
.
It can be seen that domestic and foreign experts have recognized that there are certain limitations
to PALS and/or PBLS training.

What are the limitations of PALS and/or PBLS training? Training through PALS and/or PBLS can only mean that the trainee has passed the corresponding training course and passed the examination, does not mean that he has the ability to deal with practical problems, that is, the certificate is not equivalent to the ability
.
Therefore, additional technical competence training is necessary, especially for paramedical staff who are not anesthesia professionals
.
For ethical reasons, it is not feasible to directly train airway management skills in children, but in recent years, the rapid development of domestic simulation teaching has created feasible conditions
for simulation training of airway management skills.
Therefore, the simulation training of airway management skills as a supplementary condition to the qualification recognition clause of auxiliary medical personnel should become one of the next development directions of
children's diagnosis and treatment and sedation in China.

2.
3 Fasting rules for dilemmas

Whether it is necessary to strictly fast according to clinical anesthesia standards before sedation has been a hot topic
of debate.
Since 1985, when the AAP first issued technical guidelines for sedation in the operation of diagnosis and treatment, the industry has been arguing that the risk of fasting and aspiration before sedation is equivalent to elective anesthesia and is widely recommended; At the same time, the same fasting regulations
as before elective anesthesia were determined.
Opponents argue that although sedation and anesthesia are a continuous process, it is not clear whether the same fasting interval is suitable for patients with
different sedation depths, different duration of sedation, different types of operations, and different physical states or comorbidities.
Sedation is characterized by conscious preservation of protective airway reflexes, while general anesthesia is the opposite
.

The sedation process is usually short, and airway manipulations and the use of emetic inhalation anesthetics are rare
.
Therefore, the risk of aspiration of sedation during the diagnosis and treatment procedure is certainly lower than that of general anesthesia
.
The large amount of evidence put forward by opponents believes that insufficient fasting time is not directly related to the occurrence of adverse reactions such as vomiting and aspiration, and unfortunately, the early evidence is mostly retrospective studies and lacks sufficient strong evidence
.

Fortunately, studies have now elucidated the extent and nature
of aspiration risks associated with sedation in diagnostic procedures.
The results of the study confirm that the current fasting regulations require much longer fasting times than recommended standards and can lead to adverse reactions such as irritation, dehydration and hypoglycemia in
children.
Fasting does not ensure fasting, aspiration is not associated with compliance with conventional fasting guidelines, the likelihood of aspiration during sedation is negligible, and there are no reports of inhalation-related mortality in children in the post-1984 literature on sedation in diagnostic procedures, and the theoretical basis for hypothetical risk of aspiration is insufficient
.

Given the above, current concerns about aspiration are disproportionate to the actual risk, and fasting strategies can reasonably relax restrictions
.
In March 2020, the International Committee for the Advancement of Procedural Sedation (ICAPS) released an international multidisciplinary consensus of experts, in which the content of the standard for sedation fasting in children's diagnosis and treatment is of great reference value
.
The consensus is divided into 3 risk gradients according to the different primary diseases and comorbidities of the child, and different fasting recommendations
are given according to the type of sedation and risk gradient of the child.

In general, shortening the fasting time before sedation in children's diagnosis and treatment is the trend of the future, but it still needs to be cautious in the actual clinical application process, and it must be implemented
on the basis of guidelines (consensus) and combined with the actual situation.
In the clinical practice of the Children's Medical Center, about 20,000 children who need to undergo cardiac ultrasonography due to cardiovascular diseases receive sedation every year, including many children of extreme age (newborns, premature infants) and critically ill (cyanotic congenital heart disease), considering the normal eating time interval of these children, as well as the possible adverse effects of long-term fasting, the fasting time for this part of the children is only 2h, but vomiting, Adverse effects such as aspiration are extremely rare
.
Therefore, on the basis of clinical experience, pediatric medical centers likewise tend to appropriately shorten the fasting time
before sedation.
However, it should be emphasized that even if the adverse reactions are rare, it is still necessary to make corresponding treatment plans and rescue preparations
.

Currently, the experience of pediatric medical centers is limited to children who use chloral hydrate or dexmedetomidine for sedation, and the safety of other sedative drugs still needs to be carefully evaluated
.
With regard to fasting regulations, industry associations are called upon to organize experts with clinical experience to formulate a domestic consensus for reference as soon as possible to avoid affecting the diagnosis and treatment operation, so that the anesthesiologists involved are in a dilemma that is blamed by other clinicians and parents
.

2.
4 Optimization of sedative medication regimens for diagnosis and treatment

The questionnaire survey of the Children's Medical Center found that the current domestic implementation of diagnosis and treatment sedation is still dominated by chloral hydrate and dexmedetomidine, and these two drugs are used for short-term examination without pain stimulation (such as ultrasound, CT, etc.
) with good sedation; However, prolonged diagnostic procedures (e.
g.
, MRI, especially MRI for congenital heart disease) often fail to accurately predict the onset of action and duration of sedation, resulting in children waiting for the exam or waking up during the examination, and sedation failure occurs
.

Statistics from the Children's Medical Center show that the success rate of chloral hydrate or demedetomidine monotherapy for MRI sedation in children is only about 20% to 30%, and the success rate of the combination of the two can be increased to about 80%, but its success rate is always unsatisfactory, and due to the large number of children, and the failure of sedation leads to a large waste of manpower and material resources for medical staff and children's families, which can have a huge impact on
clinical work efficiency.
How to improve the drug regimen and further improve the success rate of sedation is a problem that
must be paid attention to.

The 2018 edition of the ASA Technical Guide for Sedatives in Clinical Practice divides commonly used clinical sedative drugs into two categories
: non-general anesthetic sedation drugs (SniGA) and sedatives intended for General Anesthesia (SiGA).
SniGA includes midazolam, chloral hydrate, dexmedetomidine and barbiturates, and SiGA includes propofol, etomidate, opioids, ketamine, nitrous oxide (laughing gas) and the like
.
The general feature of SniGA is that the route of administration is diverse, and the onset and maintenance time is difficult to accurately control, especially in the case of vomiting and diarrhea in children, but it is relatively safe and serious adverse reactions are rare
.

SiGA, on the other hand, has advantages in rapid onset of action and controlled maintenance time, but there is potential cardiopulmonary inhibition
.
The rational application of these two types of sedative drugs is the key to improving the success rate of sedation in children's diagnosis and treatment operations, and it is also the future development direction
of children's diagnosis and treatment operation sedation.
The envisaged pedantic medication for pediatric procedures should be differentiated
according to the type of pedagogical procedure in the child.

For short-term, painless diagnosis and treatment procedures, SniGA can meet the sedation requirements; If the child has multiple previous SniGA sedation failures, SiGA
may be considered.
However, for long-lasting (including with painful stimuli), SiGA
is recommended to ensure successful sedation.
It must be noted that the potential cardiopulmonary inhibition of SiGA cannot be ignored, and how to safely use SiGA to perform pediatric sedation still needs to be explored
.

EP combination (a 1:1 mixture of etomidate and propofol) is a viable SiGA regimen that has been shown in adult studies to have hemodynamically stable and low incidence of respiratory depression, and its safety in children remains to be verified
.
The Children's Medical Center is trying EP combination to sedation children undergoing MRI (a single dose of 0.
2 mL/kg, which can be added as needed or maintained intravenously), and only 2 of the more than 700 cases of sedation that have accumulated so far have experienced transient respiratory depression and returned to normal
after oxygen inhalation through an open airway mask.
According to the current research results, EP combination has certain application prospects, suitable for long-lasting and pain-free diagnosis and treatment operations
.

2.
5 Standardization of sedation-related definitions is urgently needed

China Children's Specialist Hospital is characterized by a huge child base, and a large number of children receive diagnosis and treatment and sedation every year, but the base is not equal to big data
.
Big data serves the clinic, such as drug analysis, adverse reaction monitoring, complications management, treatment effect analysis, etc.
, one of the prerequisites is the standardization
of the definition of relevant clinical indicators.
Setting standards and reaching consensus is not an easy task, and here are some of the questions
.

(1) Is the sedation successful when the operation is completed? If the child has unpleasant memories, requires restraint to complete the operation, or unplanned hospital admission, is sedation successful?

(2) What is oxygen saturation decrease? The usual definition is oxygen saturation <90%, lasting ≤ 30s, if the child's oxygen saturation is transiently reduced to 90% or less, after oxygen inhalation and mandibular treatment within 30s of recovery, is hypoxemia still considered to have occurred? In addition, it is practically impossible
to count 30s accurately in a state of emergency.

(3) How to correctly define and distinguish between complete obstruction of the upper respiratory tract and laryngospasm?

(4) How to define hypotension? The recommendation of the American College of Cardiology is that the systolic blood pressure of the child is lower than the 5th percentile of the blood pressure of the child in this age group, and whether to give interventions such as infusion, drug therapy, and chest compressions is determined
.

(5) How to define the unpleasant reaction during the recovery period? There are many terms about delirium, irritability, agitation, etc.
after anesthesia, and the semantics are intertwined
.

The lack of standardized definitions and reporting guidelines for researchers to follow resulted in inconsistent
reporting results.
The use of the same definition to describe sedation, interventions, and adverse events will effectively facilitate inter-study comparisons and the pooling of data from multiple studies, thereby improving the assessment
of the risks and outcomes of sedation in children's treatment procedures.
This is the work that can be carried out but has not been carried out by the domestic industry at present
.

2.
6 Physical space cramped and inadequate equipment

As mentioned above, the sedation work of pediatric diagnosis and treatment in China has developed rapidly in the past ten years, and the number of children served has risen
sharply.
But also because of the late start, hospital architecture and space design often do not take into account the needs of this aspect in advance, except for a few new hospitals, most of the children's specialized hospitals diagnosis and treatment operation sedation implementation site in a small, far from the operating room, coupled with the lack of necessary equipment, so that the risk of sedation of diagnosis and treatment operations is greatly increased
.

If MRI sedation fails, further anesthesia is often required, but most hospitals currently lack antimagnetic anesthesia machines, monitors, and drug delivery devices
.
In 2018, seven ministries and commissions (the National Health Commission, the National Development and Reform Commission, the Ministry of Education, the Ministry of Finance, the Ministry of Human Resources and Social Security, the State Administration of Traditional Chinese Medicine, and the National Medical Security Bureau) jointly issued the "Notice on Printing and Distributing Opinions on Strengthening and Improving Anesthesia Medical Services" and policy interpretations, and the industry cheered, as if the spring of anesthesia has arrived, but the actual effect of the document has not been investigated and studied
by peers in the industry so far.

In the author's opinion, most hospital managers do not even know the existence of this document, basically to implement the document, how to let hospital managers pay attention to sedation safety and support equipment investment is a problem that must be concerned at
present.
The development of anesthesia depends on the improvement of its own strength, on the basis of a large number of preliminary work, gradually recognized by hospital administrators and other professions, in order to naturally form changes
.

2.
7 There is an urgent need for medical insurance policy support

Since the launch of the sedation service for diagnosis and treatment, the satisfaction of children and parents has been greatly improved
.
On this basis, domestic anesthesiologists have also done a lot of work in sedation technology and humanistic care, which has attracted the attention and praise of all walks of life
.
However, at present, in most parts of the country, pediatric sedation is still not a paid medical project, and the cost is not necessarily expensive, but it is a recognition of the respect for knowledge and the physical and mental work of clinicians
.
The development, implementation, popularization and charging of labor analgesia, because the implementation of maternal jumping incidents has been accelerated, is actually a lesson in blood
.

3.
Summary and outlook

The above views and suggestions are based on the experience of the Children's Medical Center in the field of pediatric diagnosis and treatment and sedation for more than ten years, and it is also a feasible future development direction
.
The problems worth exploring in the sedation workflow of children's diagnosis and treatment operation are far more than what is in the text, bold assumptions, careful verification, according to their own actual situation, design a reasonable sedation process, safe and efficient to ensure that children accept diagnosis and treatment operations will be the task
that domestic sedation practitioners must complete in the future for a period of time.

At present, China's children's diagnosis and treatment operation sedation work has been at a critical moment of development, in order to develop benign in the future, standardization and standardization is imperative
.
In view of the current situation that children's diagnosis and treatment operation sedation is still unable to charge in most parts of the country, it is difficult to carry out hardware upgrading, discipline construction, talent training and many other aspects, but even so, there is still some work that can be done, such as the optimization of medication regimens and the standardization of sedation-related definitions
.
In particular, the standardization of sedation-related definitions is the key to transforming the huge base of pediatric diagnosis and treatment sedation in China into big data, which can provide a large amount of evidence-based medical evidence
for the formulation of technical guidelines for children's diagnosis and treatment operation sedation in China.

For domestic sedation practitioners, the achievements made in the past ten years are worthy of recognition, although there are many difficulties in front of them, but looking forward to the future, the development direction is clearly visible
.
In recent years, children's diagnosis and treatment operation sedation as a necessary and has a huge demand for emerging disciplines are showing vigorous vitality, after the National Health Commission clearly proposed to increase the training of pediatricians and improve the status and treatment of pediatricians, the relevant policies are gradually tilting to pediatrics, it can be foreseen that children's diagnosis and treatment operation sedation into the scope of medical insurance payment is not far away
.
Therefore, there is every reason to believe that the immediate difficulties are temporary, and pediatric sedation will surely gain its due importance
in the near future.

Source: Li Bo,Zheng Jijian,Zhang Mazhong.
The dilemma and future of pediatric diagnosis and treatment and sedation in China[J].
Shanghai Medical Journal,2022,45(03):140-145.