The sedation provider is responsible for the final evaluation of the child prior to administration of sedation. Inadequate evaluation prior to the sedation has been found to be a factor in many adverse events [21]. A pre-sedation health evaluation should at a minimum include the patient’s age, weight, allergies, medications, vital signs, relevant family history, and past medical history (including physical abnormalities, history of snoring, and neurologic impairment that may increase potential for airway obstruction). A focused physical examination and assessment of the airway is crucial; large tonsils or anatomic airway abnormalities should be noted as they may increase the risk for airway obstruction [20, 22].

The non-anesthesia sedation provider should consult anesthesia for high-risk patients. In general, high-risk patients are those with snoring, stridor, craniofacial abnormalities, chronic lung disease, abnormal airway, vomiting, gastroesophageal reflux, bowel obstruction, asthma exacerbation, active respiratory disease (pneumonia), complex medical problems (mediastinal mass, prematurity, cardiac disease), hypovolemia, or neuromuscular disorder. An anesthesia consult is also suggested for children younger than 1 year of age or those with an American Society of Anesthesiologists (ASA) classification of three or greater [20, 24].

Medication dosages should be double-checked before administration and all resuscitation equipment and medications should be available. The SOAPME—Suction, Oxygen, Airway (appropriate-sized equipment), Pharmacy (drugs needed), Monitors, Equipment (perhaps a defibrillator)—checklist is a helpful and easy to remember pneumonic for sedation preparation [20, 22]. A “time out” must be performed before any medication is given in order to verify the correct patient, site, and medications [25]. It is important to anticipate and be prepared for complications, such as laryngospasm [26]. The Joint Commission and American Academy of Pediatrics (AAP) emphasize the concept of “sedation rescue,” which is essential to safe sedation [20, 25].

Every time a sedative or analgesic is administered there is always a chance for error. Each year, 1.5 million preventable adverse drug events occur. As many as 7,000 people die as a result of avoidable medication errors. Although hospitals and pharmacies have adopted computerized prescriptions and bar-coding equipment to decrease the chance of a medication error, errors still occur [27]. One study found that there are 3.99 errors for every 1,000 medications ordered for inhospital patients. Many are potentially serious [28]. This is due in part to look-alike and sound-alike drugs. Hospitals and clinicians must be careful to keep these look-alike and sound-alike medications separated and clearly labeled.

Many medication errors are due to incorrect computation. Some of these errors may be preventable by computer-based order sets, which have prescribing limits that restrict drug doses. Serious medication errors with a misplaced decimal point can result in a tenfold error. It is thus recommended that a zero be placed before a decimal point to express any number less than one (e.g., 0.5 mL). Alternatively, one should never use a terminal zero (e.g., 5.0), since failure to note this decimal point may result in a tenfold overdose. Avoid abbreviations (cc, μ, mL, MSO₄, N₂O) because these are not universally understood and may be misinterpreted. Preventable errors occur when the health care provider fails to either obtain an adequate history of food or medication allergies, or to read the medical history that documents an allergy [29]. Furthermore, proper supervision of sedation trainees is important. Trainees often prescribe and administer sedation to children. Lack of trainee supervision is a common factor in medical errors and resulting malpractice lawsuits [30].

Observation of the patient for an appropriate period of time following sedation and in the recovery period is critical. While it is important to establish written criteria for discharge, it is also important as a matter of administration and policy to identify who will decide when discharge criteria have been met. For example, does a nurse make the discharge decision based solely on established written criteria? Should a physician perform a final examination before discharge? Every child who receives sedation must be discharged following criteria proposed by the AAP [5, 20]. Whether the criteria has been met, and how those protocols and procedures are implemented and enforced are left to the discretion of the practitioner and the facility. The proper exercise of this discretion can raise questions of Standard of Care. A minimum return to baseline medical and cognitive status is usually expected: Cardiovascular function, an intact gag reflex, a patent airway, adequate hydration, and baseline respiratory status are critical. The child should be easily aroused and as responsive to verbal and tactile stimuli as he was prior to sedation. Younger children or those with neurologic dysfunction should return to their pre-sedation level of function before discharge. Consider a prolonged recovery stay if the accompanying and responsible guardian is alone (driving the car) or if the child has a significant underlying medical problem (neurologic impairment, respiratory disease, history of sedation-related complications) [20]. Failure to give adequate instructions and advice concerning limitation of activity and appropriate dietary precautions and a premature discharge can have disastrous consequences. Each child should be provided with a 24-h phone number that parents can call with any questions about their child’s sedation or behavior [24].

Hospitals are required under federal law and Joint Commission standards to develop, publish, teach, enforce, and drill sedation policies and procedures. Written policies are defined in the Joint Commission standards as “the formal, approved description of how a governance, management or clinical process is defined, organized and carried out.” Simply stated, policies are mandatory and should be distinguished from advisory guidelines. Failure to have written policies in place is not only a violation of law but also a violation of the federal funding requirements under Medicare. This failure could lead to a claim of a violation of standard of care against a facility, institution, and responsible administration. Although sedation providers at non-Joint Commission facilities may not be required to have such written policies and procedures, absence of or non-adherence to these policies/procedures can be evidence of a deviation from the standard of care. Hospital protocols and policies should be reasonable, so that clinicians understand and are able to adhere to them. For instance, capnography is “encouraged” for sedated children in AAP and ASA guidelines [20, 31]. However, if the hospital does not routinely use or provide end-tidal CO₂ monitoring for sedated patients, capnography should not be a requirement in the policy and procedure manual of the hospital.

The Joint Commission mandates that each institution develop its own specific protocols for any patient at risk of losing his protective airway reflex during sedation [25]. The standard of care must be consistent throughout the hospital, regardless of the location at which the sedation is administered (emergency department, clinic, radiology suite, etc.) [25]. The institution must standardize the documentation process in terms of history, physical exam, and events during the procedure and recovery period. Guidelines for informed consent ¹⁰ for procedures must be consistent throughout the institution (see section “Informed Consent”). Monitoring guidelines and requisite skills of the sedation providers must be uniform within the institution [25]. Standards for how long a child must take nothing by mouth (NPO) prior to sedation must be consistent. Although NPO guidelines have been recently challenged due to lack of published validation pertaining to outcome, hospitals must establish, maintain, and update these policies. Even in the emergency department, the administration of sedatives must be preceded by a thorough evaluation of food and fluid intake. The hospital policy may provide for modification of NPO guidelines in an emergency situation after careful consideration and documentation of the risk versus benefits of proceeding. This hospital policy should reflect that in an emergency, when proper fasting cannot be ensured, the increased risk of sedation must be weighed against its benefits [5]. In general, the minimum needed depth of sedation should be targeted in these emergency situations [20].

Hospital policy should define which clinicians can prescribe or administer specific sedative medications. For example, many hospitals permit non-anesthesiologists to administer agents such as propofol or ketamine after specific training. Others prohibit this. Such decisions are generally left to the discretion of the individual hospital, as the standard of care allows non-anesthesiologists to use such medications within appropriate guidelines [16]. The package insert information is important, but does not necessarily dictate clinical practice. Particularly for children in the USA, many medications are not approved by the Food and Drug Administration (FDA) and are administered “off label.” Accordingly, off-label use of some sedatives (propofol, for example) has been incorporated into specialty guidelines (American College of Emergency Physicians (ACEP) and American College of Gastroenterology). (Refer to Chaps. 2, 18, and 19.) In the event of a malpractice lawsuit involving sedative agents, evidence-based research and clinical usage protocols are considered. If such evidence demonstrates safe and effective outcomes for the agents utilized, the clinician may offer that as evidence to defend the use and administration of agents, such as propofol.

Hospital policies should specify which medications can or cannot be administered by nursing staff. In many states, nurses are not permitted to administer certain sedative agents. Nurses must follow the state, local, and hospital regulations. In the event of an unintended adverse outcome with sedation, deviation from these rules will be closely scrutinized.

Finally, hospital policies should address the issue of photographs and video recording of patients during sedation. In general, images of a patient during his medical care become part of the patient’s permanent medical record. They are subject to the same legal scrutiny as other parts of the medical record and may be used as evidence in the event of a malpractice lawsuit. An exception may be for images acquired by a treating physician for purposes other than medical care (such as for use in publications, lectures, or a clinical trial).

Several specialty organizations have published sedation guidelines to guide health care professionals. The AAP published guidelines for sedation in 2006 [20], as did the ACEP in 2008 [32]. (Refer to Chap. 2.) The Joint Commission defines practice guidelines as “tools that describe processes found by clinical trials or by consensus opinion of experts to be the most effective in evaluation and/or treating a patient who has a specific symptom, condition, or diagnosis, or describe a specific procedure. Synonyms include practice parameter, protocol, preferred practice pattern and guidelines.” All who administer sedation should be familiar with published clinical care guidelines. This is especially true of the guidelines accepted by a specialty. It is important that a specialist adhere to his own specialty guidelines or document his rational for deviation. Failure to follow them may well be the basis of the claim that there was a deviation from the standard of care [33]. Guidelines from major organizations such as the AAP have great impact in court. In general, a guideline supports a standard of care. It may well be viewed by the courts and juries as establishing the “rules of the road.” Surprisingly, a recent study showed that monitoring guidelines suggested by ACEP, AAP, and ASA for non-anesthesiologists were followed in only about half the pediatric cases analyzed [34]. The failure to adhere may be the basis of a claim for a liability against the sedation provider.

Guidelines for fasting (NPO) prior to sedation are consensus based rather than evidence based and thus they are debatable. Regardless, one should not disregard the fasting status of the patient [20, 22, 32, 35–37]. Documentation of the last oral intake is good practice and a Joint Commission requirement [25]. When NPO status is not adhering to guidelines and sedation proceeds regardless, documentation is critical. Consider and document the risk-to-benefit ratio, weighing NPO status against the urgency of the procedure. This will help prevent an adverse event and will help defend the care provided.

Informed consent is more than just obtaining a parent’s signature on a piece of paper. The family of a child who receives sedation is entitled to receive and understand pertinent information about the procedure and the medications to be used. Parents have the right to know about the risks and benefits of the treatment, and any available alternatives. Their consent normally must be obtained prior to administration of any sedatives. A general consent form signed upon arrival at an outpatient facility does not usually imply consent for sedation. Separate consent for sedation is strongly advised. Whether consent should be in written or verbal form depends on local, state, and institutional requirements. In many states, verbal consent is adequate for most emergency procedures. However, the best evidence of consent in the event of a subsequent lawsuit is a signed consent form. Written consent forms educate the guardian with respect to the procedure and provide some protection to the caregiver by documenting the steps taken to inform the family. However, signing a form does not necessarily equate to an informed consent [41, 42]. The guardian may still claim that the risks and benefits were not adequately explained. In the event that a specific consent form was not used, the record should clearly document what the parents were told and their verbal agreement and understanding. In a true emergency, informed consent is not needed; it is implied and assumed that a reasonable parent would want immediate necessary care [42].

For example, Pennsylvania law defines informed consent as providing the consenting person with a description of the procedure and the risks and alternatives such that a “reasonably prudent person” would be able to make an informed decision about whether to undergo the procedure. This patient-focused concept of informed consent is followed by most states. If they are not told of the risk of and alternative to the treatment, the parents could conceivably bring a lawsuit against a physician for failing to obtain informed consent. If the child suffers harm from the sedation, the parents would have to prove that reasonable people, properly advised, and fully informed would not have consented to the procedure [7].

Parents should be informed consumers. Information given should include objectives and alternatives to the medical procedure itself, as well as of the sedation and anticipated changes in behavior during and after the sedation. Parents should be informed of alternatives such as the use of local anesthesia, regional anesthesia, general anesthesia, and alternate routes of administration. One study identified that parents most often wanted information regarding induction, adverse events, emergence reactions, and pain relief [43].

Information should be given in a clear straightforward manner. The care provider should be sure that the guardian understands the information given. It may be useful to ask the parent to paraphrase what they have been told. If a serious complication could result from treatment, then the caregiver should inform the family of all but the most remote risks. On the contrary, if the potential injury is minor, the family need only be informed of the risks that are common [20, 22, 44, 45]. In general, no parent should be forced to make a specific treatment decision for a child. Most parents desire the opinion and advice of the experienced provider in order to make a reasonable determination of what is best for the child. Table 29.2 summarizes important features of the informed consent process.

Good communication among all staff members involved with sedation is essential. Do not demean other staff members in front of parents. Instead, it is best to “manage up” and praise other staff in front of families. Avoid joking or stray comments as families may believe (misinterpret) that the staff is not concentrating on their child. Communication among colleagues with respect and support is as important as communication to ensure adequate transfer of pertinent patient information. Numerous medical malpractice errors relate to the poor transfer of medical information between the responsible staff. Change of shift can be particularly dangerous, as pertinent medical information is not always communicated during handoffs [46–48].

It is never wise to alter a patient’s medical record or to make a late entry after an adverse event has occurred. Altered, missing, or “misplaced” records create the appearance of a “cover-up” and can result in sanctions. It is the responsibility of all providers involved in a child’s care to maintain and secure the medical record.

With electronic medical records (EMR) all subsequent and non-sequential entries are obvious and apparent. Even handwritten notes can be analyzed by a forensic expert in order to uncover late entries. The authors advise that in order to correct a handwritten note, draw a single line through the error and initial and date it. Do not attempt to cover up the mistake by blacking out words or phrases. Should litigation ensue, it will be easier to explain missing facts or a poor record than it will be to defend a record that has been altered [49].