|Year : 2007 | Volume
| Issue : 3 | Page : 169-175
Paediatric procedural sedation - a review and an update
Rebecca Jacob1, K Ilamurugu2, N Amar3
1 MD, DA, Professor, Department of Anaesthesia, Christian Medical College, Vellore, India
2 MD, DA, Jr Lecturer, Department of Anaesthesia, Christian Medical College, Vellore, India
3 MD, DA, Registrar, Department of Anaesthesia, Christian Medical College, Vellore, India
|Date of Acceptance||15-Apr-2007|
|Date of Web Publication||20-Mar-2010|
Professor, Department Of Anaesthesia, Christian Medical College Hospital, Vellore-632004, Tamil Nadu
Source of Support: None, Conflict of Interest: None
Sedation and analgesia are frequently administered to paediatric patients for procedures done outside the operating room. Both diagnostic and therapeutic procedures are now being increasingly done outside the operating room partly due to time constraints, partly in an effort to decrease cost and partly due to fear of complications of sedation. So children are often subjected to sedation by unskilled personnel with little or no training in resuscitation. In other cases children who would have benefited by sedation are being denied sedation and/ or left with long term psychological scars. The fear of undergoing a painful procedure or a procedure in unfamiliar surroundings remains considerably high. This is especially true in young children and mentally handicapped children. The whole issue is compounded by parental anxiety, separation from parents and pain or anticipation of pain during the procedure. It is poorly understood that procedures done outside the operating room require the same attention to anxiolysis, analgesia, sedation and safety guidelines as procedures performed in the operating room. To this end we require appropriate definitions, goals, guidelines, monitoring and adequately trained personnel. In this review and update we have examined the international guidelines, looked at the drugs which may be used, and safety constraints. We also have enunciated guidelines for procedural sedation in children which may be adapted to the Indian scenario.
Keywords: Procedural sedation, Analgesia; Paediatrics, Safety guidelines.
|How to cite this article:|
Jacob R, Ilamurugu K, Amar N. Paediatric procedural sedation - a review and an update. Indian J Anaesth 2007;51:169-75
| Introduction|| |
Many diagnostic and therapeutic procedures are necessary interventions in children. The mere restraint of a child for a frightening or painful procedure is clearly unjustified and they require the same attention to anxiolysis, analgesia and sedation whether the procedures are carried out within or outside the operating room.
Painful procedures that are frequently performed outside the operating room include bone marrow aspiration, lumbar puncture, repair of minor surgical wounds, insertion of arterial and venous cannulae and catheters, burns dressing changes, fracture reduction, bronchoscopy and endoscopy.
Non painful procedures may require immobility and/ or sedation to improve the quality of the diagnostic tool and also to reduce time and cost incurred by delays  . Young children and the physically or mentally handicapped may be unable to remain still for even short periods of time. Even older children may suffer from a fear of strange and confined space and this anxiety may be made worse by anxious parents. Non painful procedures include computer tomography, magnetic resonance imaging, positron emission tomography, electroencephalography and electromyelography.
Paediatric sedation techniques should ideally be customized for the patient and procedure performed. For example, a distinction should be made as to whether the procedure is long or short, requiring position changes or shifting to various locations or involving significant pain and discomfort. 60 to 150 minute sedation seems inappropriate for a 5 minute, non painful procedure  . Does anyone check the delayed side effects? , On reviewing the literature it is seen that there is little agreement as to which medications, techniques, practice settings or even personnel should be involved in providing sedation for these procedures. In fact a myriad of care givers administer sedation. They are administered by many paediatric and non-paediatric specialists, nurses, technical staff, in less than ideal conditions, most often with the idea of doing the interventions at minimum cost. Reports of sedation experience and innovations are relatively rare in anaesthesia literature, perhaps because anaesthesiologists do not believe these were worth reporting. The resulting perception by other medical specialties is that anaesthesiologists are experts only in the operating room domain and paediatric sedation will become the premise of intensivists and emergency room specialists.
The new environments and expectations of sedation and analgesia for diagnostic and therapeutic procedures outside the OR show that they cannot all be managed by anaesthesiologists as there are just not enough anaesthesiologists to achieve this. Published trends are clearly towards the use of potent sedatives and hypnotics by non anaesthesiologists, , though some groups like the SIAARTI of Italy  clearly state that the administration of sedation by non anaesthesiologists should be limited to minimal and moderate sedation of patients with good physical status. It is, therefore, important for us to get involved in formulating appropriate definitions, goals, guidelines, monitoring requirements and training personnel so as to decrease the risk to the paediatric patient.
How does one measure the 'success rate' of sedation? Literature rates failure between 1-3% to 10-20% , . How is this rating done? Is it just that the procedure was done or was it done to the satisfaction of the patient, the parent and the care giver? Does one rate as successful when the child screamed through an LP and then slept for 2 hours after or a short deep sleep with immediate recovery?  .
| The Goals of sedation|| |
The most important goal of paediatric sedation is safety . In addition one tries to
History of the evolution of sedation guidelines 
- Minimize physical discomfort and pain while making it possible to do the procedure properly.
- Control behavior. Minimize negative psychological responses to treatment by providing analgesia and anxiolysis and maximize potential for amnesia
- Guard the patients' safety and welfare
- Return the patient to a state in which safe discharge is possible.
The first guidelines for monitoring children sedated for diagnostic procedures was written by Cote and Striker and published by the American Academy of Pediatrics (AAP) in 1985.  This was reviewed in 1992, but the term conscious sedation caused considerable confusion and hence was removed from the guidelines. The Committee on Drugs of the AAP amended these guidelines again in 2002  . These were widely accepted and the Joint Commission for Accreditation of Health Organizations (JCAHO)  made Departments of Anaesthesia responsible for developing within institution sedation guidelines, thus getting the American Society of Anaesthesiologists (ASA) involved. They developed the sedation guidelines for anaesthesiologists and non anaesthesiologists with a strong emphasis on safety.
An additional concept is stressed, that of rescue, in that the practitioner must have the skills to rescue the patient should the patient go to the next higher level of sedation. Thus they stress on the needs for conformity in the administration of sedation, in the equipment and facilities in the areas where sedation is administered as well as in the training of personnel and staffing of these areas. Recently more has been added about the recovery areas and discharge criteria relating to procedural sedation.
The four levels of Sedation and Anaesthesia , as defined by the JCAHO (continuum of sedation) on recommendations made by the ASA are as follows
[Additional file 1]
Minimal sedation (anxiolysis): A drug induced state during which patients respond normally to verbal commands. Although cognitive function and co-ordination may be impaired, ventilatory and cardiovascular functions are unaffected. This is rarely adequate for therapeutic procedures or completion of diagnostic procedures.
Moderate sedation/analgesia: A drug induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway and spontaneous ventilation is adequate. CV function is usually maintained. This level of sedation was referred to as conscious sedation in the past. The old terminology is confusing and inaccurate and is no longer used.
Deep sedation/ analgesia: A drug induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. Reflex withdrawal is not considered purposeful. The ability to maintain ventilatory function independently may be impaired and may require assistance in maintaining a patent airway. Cardiovascular function is usually maintained.
Anaesthesia: General Anaesthesia is a drug induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to maintain independent ventilatory function is often impaired. They need assistance with maintaining their airway and positive pressure ventilation is often required to maintain adequate gas exchange. CV function may also be impaired.
One more category, that of Dissociative Sedation, has been added by the European paediatricians. This is defined as a trance like cataleptic state induced by the dissociative agent ketamine or s- ketamine and characterized by profound analgesia and amnesia with retention of protective airway reflexes, spontaneous respiration and cardiopulmonary stability  .
| Risks, complications and safety issues associated with sedation|| |
True sedation disaster (fatality) is rare and the number of cases reported in these studies are too small to truly interpret the safety of any of the methods of sedation. Fatalities reported, though few, may only be the tip of the iceberg as studies of rare events require thousands of cases. There are simply no large, sufficiently powered, multi center trials to evaluate the safety of paediatric sedation.
It is for this reason that common events such as desaturation, airway obstruction, apnoea, or other respiratory or cardiovascular events may be used as surrogate markers for the serious but rare events such as death or neurologic injury.
Literature is replete with descriptions on how safe it is to sedate children in various settings - dentistry, radiology, emergency services and upper GI endoscopy - without a fatality. They all cite incidences of hypoxia, hypotension or airway obstruction which were managed 'successfully' with no fatality. This often does not truly reveal the safety of the sedation practice but the effectiveness of their 'rescue' practices. So one must take into account the setting in which these studies were done and remember that if rescue systems are not as good, the outcomes could be disastrous.
After studying 95 sedation related adverse events with 51 deaths and 9 permanent neurological injuries, Cote remarked that the majority of fatalities were not related to specific medications, the majority was preventable, a number were attributable to operator error and there was usually a lack of robust rescue systems. 
Certain conclusions can be drawn from various studies ,,.
Further conclusions include
- All areas using sedation have reported adverse events
- Most complications from sedation were avoidable
- All classes of drugs (sedatives, barbiturates, benzodiazepines and narcotics) have been associated with problems even when administered in recommended doses.
- Adverse events involved multiple drugs (especially three or more sedating medications), drug errors or overdose, inadequate medical evaluation, inadequate monitoring, inadequate practitioner skills and premature discharge.
- Respiratory depression, airway obstruction, desaturation and apnoea are the most frequently encountered initial adverse events and cardiac arrests and neurological damage occurred as secondary adverse events.
- Children 1 to 6 years of age are at greatest risk. Most had no severe underlying disease.
Guidelines are mainly directed to the non anaesthesiologists who provide sedation outside the OR but anaesthesiologist should also take note of the following
- Uniform guidelines for both in-hospital and out-ofhospital sedation must include appropriate personnel skilled in airway management and resuscitation so as to successfully manage complications.
| Presedation|| |
1) Pre sedation assessment
2) Presedation documentation
- Check whether the child is appropriate for sedation.
- Do a health evaluation and check for airway, medical problems and current medications.
- Check weight and record it for calculation of drug dosage.
Patients and relatives should be made to understand the risks and options. Talk to the older child and see whether he understands as well.
- Verbal and written instructions to a responsible person
- Dietary precautions and NPO status
- Health evaluation
- Record of and instructions pertaining to current medications
[Additional file 2]
3) Sedatives should not be administered at home or in an area unsupervised by medically trained personnel since unrecognized complications can lead to disaster.
Sedatives should be administeredonly by appropriately trained health care providers and only in a facility where appropriate monitoring and personnel are available.
4) Re evaluation should be done just prior to sedation in terms of
Preparation for sedation - check list 
- Checking pre sedation documentation
- NPO status
- URI or fever
- Medication intake
A commonly used acronym that is useful in planning and preparation for a sedation procedure is SOAPME:
S (suction) -functioning suction apparatus, suction catheters
O (oxygen) -flow meters and oxygen source
A (airway)- size-appropriate airway equipment nasopharyngeal and oropharyngeal airways, laryngoscope blades [checked and functioning], endotracheal tubes, stylets, face mask, bag-valve-mask or equivalent device functioning
P (pharmacy)-all the basic drugs needed to support life
M (monitor) - functioning pulse oximeter with size appropriate oximeter probes and other monitors as appropriate for the procedure (e.g. noninvasive blood pressure, end-tidal carbon dioxide, ECG, stethoscope)
E (equipment)-for anaesthesia and resuscitation, good lighting and communication
| During sedation|| |
- There should always be a person, in addition to the practitioner, whose responsibility is to monitor appropriate physiologic parameters and to assist in any supportive or resuscitation measures if required. If the child becomes too deeply sedated it should be one persons sole responsibility to monitor and maintain the patients vital signs, airway patency and adequacy of ventilation.
- Documentation should be on a time based flow sheet on which vital signs including level of consciousness, details of drug administration and adverse events may be recorded. This flow sheet should be easy to use, complete and comprehensive. It should also be uniform throughout the hospital.
| Post sedation care|| |
- Should be in a special recovery area with a functioning suction apparatus and the ability to provide 90% oxygen or more via a bag and mask. The vital signs should be recorded every 15 mins
- Post procedure and post discharge status ,, should be assessed and discharge criteria clearly enunciated and strictly adhered to
| Recommended discharge criteria include|| |
Cote in an editorial  asks what the safety implications are when it often takes longer for children sedated with chloral hydrate for MRI to recover than children anaesthetized for the same procedure. Malviya uses a simple criterion  for safety at discharge in asking the question - can the child stay awake for 20 minutes when undisturbed?
- Cardiovascular parameters are stable and satisfactory
- Airway patency ensured and satisfactory
- Child is easily aroused and protective reflexes are intact
- Patient can speak (if age appropriate)
- Patients can sit or walk with assistance (if age appropriate)
- Presedation level of consciousness is achieved
- Hydration is adequate
| General guidelines|| |
1) Onsite equipment of appropriate sizes should be immediately available including
2) Facilities, personnel and equipment should be immediately available to treat emergency situations arising from sedation including vomiting, aspiration, seizures, anaphylaxis, respiratory depression, airway obstruction, hypoxia, apnoea and cardiac arrest. Aprotocol should be in place to access back up emergency services if required.
- positive pressure oxygen delivery system
- suction apparatus and catheters
- pulse oximeter
- noninvasive blood pressure monitor
- emergency cart with age and size appropriate equipment
In non hospital settings emergency backup and ambulances should be readily available.
3) Outcome data should be collected to improve patient care.
4) Personnel training should be competency based and this should cover
Health care personnel who sedate children for procedures should have advanced airway training and resuscitation skills so as to successfully manage complications.
- evaluation of patients
- emergency/elective cases
- performing sedation
- taught to 'rescue' the patient from the next level of anaesthesia, that is, those performing moderate sedation should be able to recognize and rescue the patient from deep sedation and those performing deep sedation from general anaesthesia.
| Current sedation strategies|| |
Sedation is not a primary therapy but rather a treatment of procedural side effects such as pain, anxiety and dangerous movement. Inability to handle these side effects may mean the avoidance of sedative drugs and the occurrence of dangerous side effects. Thus, though no child may die of their pain or stress, physical restraint and anxiety. Psychological trauma to patient and parents, as well as loss of valuable time and less than optimal results will be the price to pay for not sedating them.
A sedation plan analyzing the requirements for analgesics, anxiolytics or both is necessary for each patient and will vary depending on the procedure and the anxiety of the patient or family. Psychological techniques to allay anxiety, cuddling, parental support, warm blankets, and a gentle reassuring voice and hypnosis are extraordinarily useful adjuncts to the sedation plan.
In short, the person administering the drugs should check what the procedure is, the duration of the procedure, whether analgesia is required, which drug has the best efficacy for that procedure, the lowest dose with the highest therapeutic index, sedation and safety profile for that procedure and whether he or she is capable of rescuing the patient from the next level of sedation if required.
Implementation of the 2001 Joint Commission on Accreditation of Healthcare Organizations guidelines for the provision of Procedural sedation appeared to lead to a decrease in the incidence of adverse events .
Implementation of successful sedation guidelines will involve organization and formulation of policy, education, credentialing, record keeping, enforcement and continuing quality improvement. This is a tremendous task and is best done by a 'sedation committee' consisting of anaesthetists and non anaesthetists who are involved in paediatric sedation.
The development of a systematic approach to sedation creates a safety net that will protect children while providing sedation and analgesia for procedures. The effect on incidence of adverse events appears to be a marked decrease if uniform standards of monitoring and care for paediatric sedation and analgesia are provided throughout the hospital  .
- The department of anaesthesia can help by playing a pivotal role in formulating policy as for example deciding
[Additional file 3]
the limits of sedation which may be used by a non anaesthetist.
- Education and training of staff taking into account staff turnover is another important area. Pre sedation assessment of patients, safe use of various drugs and regular attendance at education programs aimed at life support credentialing should be stressed
- Review committees are essential to check compliance with policy, monitor critical incidents and define where the 'system broke down or what went wrong, for example, inadequate history taking, inadequate monitoring, inadequate recovery procedure etc.
Although different patient needs, practice requirements and location limitations produce problems that are individual and specific; the approach described above is eminently feasible. It can be accomplished easily without compromising patient comfort while ensuring patient safety.
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