Part II: Specific Scenarios, Topical Agents, and Establishment of Procedural Sedation Policy within the Emergency Department
Authors: Jonathan Glauser, MD, FACEP, Department of Emergency Medicine, Cleveland Clinic Foundation, Cleveland, OH; Faculty, Emergency Medicine Residency, MetroHealth Medical Center, Cleveland, OH; Brian Cullison, MD, Resident, Department of Emergency Medicine, MetroHealth Medical Center, Cleveland, OH.
Peer Reviewer: Sandra M. Schneider, MD, FACEP, Professor and Chair, Department of Emergency Medicine, Strong Memorial Hospital, University of Rochester, NY.
The appropriate management of pain and anxiety in the emergency department (ED) is an important component of emergency care in all age groups. Administering medications for analgesia and sedation can facilitate interventional procedures and minimize patient pain and suffering. The use of such medicines, or procedural sedation, is an integral part of the practice of emergency medicine. Procedural sedation is performed regularly by other non-anesthesiologists, including gastroenterologists, radiologists, and cardiologists.1
For successful and safe procedural sedation, appropriate drugs and dosages must be chosen and administered in the proper setting on appropriate patients. Patient evaluation should be performed before, during, and after their use.
Part I of this article discussed the variety of agents available to the practicing emergency physician for procedural sedation. Part II will provide a pragmatic overview of the logistics of procedural sedation. Starting with choosing appropriate patients, this article will summarize the steps of a successful sedation, including preparation, monitoring, documentation, and post-procedure care. Specific scenarios in which sedation is employed will be reviewed, as will the use of topical agents in the ED.—The Editor
Patient Selection
The emergency physician determines whether a patient is appropriate for procedural sedation. This determination is based on the intended procedure, the patient’s medical status as defined by the history and physical exam, and by the level of sedation/analgesia required to complete the procedure. Recent food intake is not a contraindication for administering procedural sedation and analgesia, but should be considered in choosing the depth of sedation. The American Society of Anesthesiologists (ASA) recommends fasting six hours for solids and two hours for liquids,1 but the literature does not show a change in outcomes or adverse events with fasting for procedural sedation.2,3 Ranitidine and metoclopramide can be given 30-60 minutes prior to sedation to increase gastric pH and reduce gastric volume.4 NPO guidelines by age are summarized in Table 1.
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In complicated patients, or patients with severe systemic disease in which the sedation/analgesia and the complexity of the procedures would reduce the patient’s reserve, the physician may find an anesthesiology consult helpful in determining if the ED or operating room is best for the required procedure. Likewise, the physician should use caution in patients with significant oxygenation or anatomic airway/ventilation abnormalities as noted by history or physical exam (see below). Relative contraindications include hemodynamic instability, respiratory depression, and significant underlying medical problems.
In children, patients with severe systemic disease (ASA III or IV), infants younger than 3 months of age, premature infants younger than 60 post-conceptual weeks of age, and children with underlying respiratory airway disease, neurological conditions, central nervous system (CNS) injury, multiple trauma, or liver/kidney disease are at increased risk for sedation complications and require consultation with an anesthesiologist.5-7 This discussion applies only to patients classified as ASA I or II. (See Table 2.)
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Preparation
To enhance ED flow, the emergency physician should communicate clearly with the consulting physicians and nursing staff, so that all procedures on a given patient requiring procedural sedation and analgesia can be performed at the same time, and adequate nursing staff are available for monitoring the patient. For deep sedation, the person responsible for monitoring the patient should not be supervising, directing, or performing any part of the procedure, and should remain at the head of the patient at all times.
As part of the procedure ledger, a pre-procedure history and physical examination is performed on the patient and documented. Pertinent aspects include medical history, particularly cardiac or pulmonary disease, sleep apnea, renal or hepatic disease, and prior CNS disease. (See Table 3.) Alcohol, tobacco, or illicit drug use; previous problems with sedative or analgesic agents; current medications; allergies; pregnancy status; and last oral intake must be documented. A history of prior sedation/analgesia, including the adequacy of pain control for those procedures, can be helpful. Along with vital signs and oxygen saturation, the examination may include auscultation of the heart and lungs and examination of the airway for potential problems. (See Table 4.) Baseline ambulation status should be documented.8
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Pertinent laboratory evaluation and/or radiographs should be considered. Currently, there is no literature to support the need for specific laboratory testing before procedural sedation and analgesia. Laboratory testing should be driven by the patient’s comorbid status.
Finally, discussion should take place with the patient or legal guardian about the risks, benefits, and alternatives to sedation as well as the planned procedure, and to obtain informed consent. (See Table 5) Written and verbal post-procedure and sedation discharge instructions are reviewed with the patient and/or responsible adult prior to the procedure.4,6,9 Documentation and appropriate signatures are obtained before any medication is administered. The patient must have a responsible adult with whom to be discharged home once the procedure is finished.7
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Obtaining and preparing the appropriate equipment for the sedation and for managing the airway is paramount prior to beginning the procedure. A nurse or respiratory therapist dedicated to the sedation, and who is skilled in the use of airways, bag and mask, and monitors, and knowledgeable about the pharmacology of sedatives and analgesics, should be at the patient’s bedside throughout the procedure and recovery period. Oxygen delivery equipment (bag-valve mask, nasal cannula, and or/face mask) must be available at the bedside. Age-appropriate resuscitation equipment, including oxygen, intubation equipment, suction, emergency cart, and defibrillator likewise are immediately available at all times.10
A respiratory therapist, if available at the particular institution, should be notified of all conscious sedation procedures and ensure availability of all necessary airway and oxygen equipment at the bedside. The therapist provides an additional set of hands for assistance with any needed airway management. Capnometry is recommended for patients with the potential for decreased hypoxic ventilatory drive.11
Drug reversal agents, such as flumazenil for benzodiazepines and naloxone for narcotics, sometimes are used to aid in the recovery process, and must be available for immediate use. In pediatric patients, premeasured doses should be prepared at the bedside.
Monitoring
Patients who are at risk for respiratory depression and/or airway compromise, including those who have undergone deep sedation, require a high level of monitoring. This entails the presence of a physician, nurse, and respiratory therapist during procedures performed upon such patients. Intravenous (IV) access with immediate bedside availability of reversal agents, intubation, suction, and airway and oxygen equipment must be present. With the exception of those patients who have received dissociative agents, patients who are unable to follow commands are potentially at risk for airway compromise.5,11
Intraprocedural monitoring is documented on a monitoring record throughout the procedure. Cardiorespiratory monitoring should be performed on all patients. This includes, but is not limited to, noninvasive blood pressure, electrocardiogram (ECG) monitoring, pulse oximetry, and vital sign observation. During deep sedation, vital signs are recorded every five minutes. For other conscious sedation this should be no less frequently than every 15 minutes for adequate safety. The patient should not be left unattended at any time during the procedure.5
The Bispectral index (BIS monitor) is an innovation used commonly in the operating room and other settings, and increasingly in conscious sedation. Through EEG waveform monitoring, the monitor documents the patient’s level of sedation and gives an analog value 0 (no brain activity) to 100 (awake).12
Vital signs and level of consciousness should be assessed and recorded at a minimum before the beginning of the procedure, after administration of sedative/analgesic drugs, and at regular intervals during a procedural sedation, and at the end of the procedure. The Modified Ramsay Score is a convenient, accepted nomenclature for documenting sedation. (See Table 6.) For normal conscious sedation cases, a patient does not remain below level 4 for longer than 15 minutes, and does not reach level 5 or 6. For deep sedation, patients normally do not remain at level 6 for longer than 15 minutes.
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Pulse oximetry is used to assess oxygenation continuously and quantitatively. In general, oxygen saturation should be maintained with oxygen at greater than 95%. In patients with chronic hypoxemia, a reasonable goal is to maintain saturation at or above their baseline.1,2 Capnography can be used to monitor ventilation.3,9
Electrocardiographic monitoring should be considered for use on those patients who have or are at increased risk for cardiac disease. This may include, but not be limited to, those with a history of congestive heart failure, dysrhythmias, diabetes, coronary artery disease, peripheral vascular disease, age over 50, and a smoking history of more than 20 packs per year.1,11
In certain circumstances, one of the above monitoring requirements may be suspended temporarily if performance of that requirement would result in interference with the procedure (i.e., computed tomography [CT]/magnetic resonance imaging [MRI] scans). The requirement for monitoring heart rate and oxygen saturation by pulse oximetry, however, never should be suspended.
Specific Scenarios
With most agents, slow, careful titration is the key to safe and effective procedural sedation and analgesia. The physician aims to balance sedation and analgesia, having a goal of a patient who is drowsy and falls asleep when not stimulated and who experiences no pain. Cautious titration of the analgesic (i.e., morphine) and sedative (i.e., midazolam) to achieve this balance is the key to safety, efficacy, and, ultimately, patient satisfaction with the experience.
In titrating the medications, it is important to wait 2-3 minutes for the medication to equilibrate. Further, injections should be given slowly over 1-2 minutes to decrease the risk of sudden drop in mental status or respiratory effort.
Sedation for the Ventilated Patient. Once intubated, many patients will require sedation to tolerate mechanical ventilation and to maintain an artificial airway. Inadequate sedation has been shown to be a significant risk factor for unplanned extubation.13,14
Benzodiazepines are the most commonly used sedative agents in the intensive care unit (ICU) setting.15,16 Midazolam and lorazepam are the most frequently used in the pediatric ICU.17 Lorazepam is given in a continuous infusion at 0.025-0.1 mg/kg/hour, up to 2 mg/hour in children. The loading dose is 0.05- 0.1 mg/kg. The propylene glycol vehicle may cause acidosis with extended use. Duration of effect is 10-20 hours.
Midazolam is given as a continuous infusion at 0.05-0.2 mg/kg/hour in children following a loading dose of 0.02-0.2 mg/kg. In adults, the typical infusion is 0.02-0.10 mg/kg/hour, or approximately 1-7 mg/hr. Metabolism may be affected by hepatic dysfunction.18 Long-term infusion (more than 100 hours) may cause a transient encephalopathy, with choreoathetosis, dystonic posturing, and decreased alertness.
Propofol may be given in a pediatric dose of 0.025-0.130 mg/kg/min.19 At all times, the patient must be monitored for respiratory depression. Even after continuous infusion, recovery from sedation is rapid, on the order of 3-6 minutes.20 In patients older than 16 years, an infusion rate of 50 mcg/kg/min or 3 mg/kg/hour has been shown to acceptably sedate more than 50% of patients.21 With initiation of any increase in infusion, a bolus of 1.0-2.5 mg/kg generally is administered. Propofol can induce hypotension and mild myocardial depression.22
Barbiturates infrequently are used in this role, due to their relatively long duration of action and potential for global CNS and myocardial depression.23 Ketamine in a dose of 0.5-1.0 mg/kg/hour has been used in children,24 but due to potential side effects, including emergence phenomena and potential to decrease seizure threshold, either benzodiazepines or propofol is preferred.
Pediatrics
Procedural sedation in pediatric patients is similar to the adult population, though the physician must take into consideration the different pharmokinetics in infants and children. As a generalization, the younger and smaller the child, the longer the clearance time and drug half-life due to decreased metabolizing capacity and protein-binding capacity.
The trauma involved with placing IV lines in infants or small children often makes non-IV forms of sedation, such as oral, nasal, rectal, or intramuscular (IM), more attractive. As examples, rectal methohexital for imaging procedures (e.g., CT and MRI) in pediatrics has taken on an increasing role due to its ease of administration and rates of success.25-27 For oral delivery of fentanyl, as noted in part I of this article, oral transmucosal fentanyl citrate (OTFC) is available as a raspberry-flavored lozenge that can cause conscious sedation in an efficacious and safe manner for diagnostic or therapeutic procedures.28
It is critically important that dosages be calculated using a weight obtained in the ED and that equipment and resuscitation medications be size and age appropriate before commencing.
Sedation for Non-painful Conditions: Pediatric CT and MRI Scans
Relative immobility is essential during painless procedures such as radiographic imaging that may, nonetheless, produce anxiety. The goals for these procedures are hypnosis and immobility to facilitate the procedure at hand while ensuring patient safety. Ages of 7-8 years have been cited as old enough for children to comply with instructions and hold still.29 However, with more rapid multisectional helical CT examinations, it has been reported that only 8% of those children age 1 year or younger required any sedation at all to undergo body CT.30 As with other agents, only ASA Class I and II patients should be considered for sedation for procedures to manage nonlife-threatening problems. (See Table 2.)
In general, the practitioner has a choice of the following agents: pentobarbital or other short-acting barbiturate, chloral hydrate, a benzodiazepine such as midazolam, or propofol. Of these, pentobarbital and chloral hydrate are used most frequently.
Pentobarbital is an oxybarbiturate analog that induces sleep within 1-2 minutes of IV administration. Sedation is achieved reliably by IV administration of pentobarbital, a short-acting barbiturate with no analgesic effect. Two to 6 mg/kg are infused slowly in increments of one-half to one-quarter of the total dose, titrated to desired response.31 Up to 9 mg/kg total IV have been recommended for radiographic procedures.32 Alternatively, it may be given IM at a dose of 5-6 mg/kg, although an additional dose of 1-3 mg/kg may be required 15% of the time. Time to sedation typically is 2-5 minutes via this route, with time to recovery after IV pentobarbital of approximately 55 minutes.33 Oral pentobarbital (Nembutal) may be used, in a dose of 4-6 mg/kg, mixed with cherry syrup, in infants undergoing CT or MRI. In one study, it was better tolerated by patients than was chloral hydrate.34
Chloral hydrate 35-75 mg/kg may be given orally as an alternative, up to a maximum dosage of 100 mg/kg or 1 gram total in children younger than 1 year.32 It has been used for many years for light sedation for radiographic studies.35,36 Its absorption is erratic, and it has slow onset. Repeat dosing frequently is necessary, and its use has led to respiratory depression and death.37,38 Onset to sedation is 30-105 minutes, with recovery time of 60-120 minutes typically.33 Since discharge before the patient is completely awake is ill-advised, and because of delayed onset of action, chloral hydrate is considered to be a poor choice in the busy ED setting.39
Benzodiazepines such as midazolam have been advocated by some for sedation with immobility; however, it has been shown to be unreliable for this purpose. In one report, children ages 6 months to 6 years requiring head CT scans were given either pentobarbital 2.5 mg/kg IV dose, followed by two 1.25 mg/kg doses at 1-minute intervals (total dose of 5 mg/kg over 3.5 minutes), or midazolam in a 0.1 mg/kg IV dose followed by two 0.05 mg/kg doses. Each midazolam dose was given over 2 minutes, followed by a 2-minute wait, for a total dose of 0.2 mg/kg over 10 minutes. Three of 26 children in the midazolam group had good sedation, while 28 of 29 in the pentobarbital group had good sedation.40 Diazepam 0.2 mg/kg and alprazolam 0.5 mg/23 kg also have been used for sedation for magnetic resonance imaging.41 When immobilization is necessary, a short-acting barbiturate or propofol is more likely to be efficacious.39
Sedation can be performed on a patient with a full stomach in emergent situations. It generally is recommended that age-specific fasting guidelines be adhered to whenever possible. These are summarized in Table 1.42,43
Topical Agents
While not producing sedation per se, there are several topical agents that may aid in the performance of certain procedures, including venipuncture, lumbar puncture,44 or laceration repair. Nerve blocks and tissue adhesives are considerations for laceration repair that are beyond the scope of this discussion.
Eutectic mixture of local anesthetics (EMLA) cream consists of an emulsification of highly concentrated anesthetics lidocaine and prilocaine in a ratio of 1:1 by weight (lidocaine 2.5% and prilocaine 2.5%).45,46 The high concentration and small droplet size promote anesthetic penetration of intact skin. Ideally, patients can be identified in triage or registration who may require IV placement, to allow 60 minutes of application time. Total dosage recommended is 2.5 grams, applied 60 minutes prior to the planned procedure. The emulsion must be used on intact skin, not left for more than 2 hours, and not applied to large areas due to risk of lidocaine and prilocaine toxicity.
Depth of anesthesia ranges from 3 mm after 60 minutes to 5 mm after 90-120 minutes of the cream’s application under an occlusive dressing.47 Predisposition to methemoglobinemia is a contraindication to prilocaine use. The time frame involved for adequate absorption limits its utility in EDs. Also, it is not sterile and is not used for anesthesia of lacerations or open wounds. Local reactions such as erythema and blanching may occur, but the incidence of severe or systemic reactions is very low. Most commonly, EMLA cream is used in pediatrics for topical anesthesia, applied approximately 1 hour prior to arterial puncture, lumbar puncture, vascular cannulation, or venipuncture.
Tetracaine, adrenaline, and cocaine (TAC) solutions or gels generally contain 0.5% tetracaine, 0.05% adrenaline, and 4-11% cocaine. It is a controlled substance due to the cocaine content. The mixture provides local anesthesia 20-30 minutes after instillation into an open wound, and lasts 45-60 minutes.47,48 Until recently, TAC was the most commonly used topical anesthetic in the United States. However it is 10-20 times more expensive than lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5% (LET) (below), and case reports of seizures, respiratory arrest, and death from absorption of cocaine systemically from incorrect application have led to more limited use.
Toxicity from rapid absorption makes the use of these solutions dangerous on mucous membranes and large abrasions. Total dose recommended is 1-3 mL. TAC should not be used on digits and other areas with end-arteriolar blood supply. It must be refrigerated. TAC does provide good hemostasis, does not distort wound edges, and can be applied painlessly. Because of necessary drug control measures , as well as the risk of seizures and death associated with the cocaine component of TAC, some prefer other topical agents.50,51
Lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5% (LET) also may be used topically, and has been found to be as effective as TAC in local anesthesia for laceration repair. Dripped onto a wound or taped on with gauze, LET produces maximum anesthesia after 20 minutes. As with TAC, it must be made freshly and refrigerated. Greater anesthesia is achieved in scalp and facial wounds than extremity or truncal wounds. Physicians should avoid using LET on mucous membranes, the nose, penis, fingers, toes, and the ear. As a gel (with methylcellulose powder) it may be used cautiously near the eyes, nose, or mouth. It is less expensive than TAC, and requires fewer drug control measures.52,53
Tetracaine 4% cream applied under occlusion for 40 minutes in children provided complete anesthesia in 62%, and acceptable anesthesia in 85% of recipients.54 It did not affect rates of successful venipuncture. It provides anesthesia for up to 4 hours and induces some vasodilation.55
Iontophoresis entails using a 9-volt battery to generate an electric current that draws ionized 2% lidocaine and epinephrine from an electrode well through intact skin. The unit’s current of 4 mA achieves an anesthetic depth of 5-7 mm by 10 minutes. Total dose is 0.6-1.0 mL, with onset of 12-20 minutes and duration of 30 minutes.56
Children age 7-18 years reported less pain during IV placement after 11 minutes of iontophoresis of 2% lidocaine with epinephrine compared with placebo.57 Dermal anesthesia with iontophoresis of lidocaine has been found to be more effective than that achieved with lidocaine/prilocaine.58 Iontophoresis is contraindicated in fingers, toes, nose, and penis because of the epinephrine component. (See Table 7 for a summary of the dosages and use of these agents.)59
Post-Procedure Care
If a recovery area is used, it should be equipped with appropriate monitoring and resuscitation equipment. As with the procedure, an individual capable of monitoring patients and able to recognize complications of procedural sedation/analgesia should be present. The physician performing the procedure or his/her physician designee should be available immediately for consultation until the patient is discharged.
Patients who still are sedated at the end of the procedure or those who received narcotic or benzodiazepine reversal are recovered within the ED prior to discharge home. The duration of all agents used, especially including reversal agents, must be taken into consideration before discharging the patient. Due to the relatively brief half-life of existing reversal agents, patients usually are observed for up to 2 hours after administration of naloxone or flumazenil.
To ensure safe recovery, vital signs and level of consciousness continually are assessed until the patient’s mental status has returned to baseline and the patient completely awakens from the sedation. Recovery should take place in the presence of an individual capable of monitoring patients and recognizing complications. Vital signs are monitored until they are within 20% of the patient’s normal range. Assessment for pain, wound drainage, any nausea and vomiting, bladder distention, or compromised neurovascular status should be carried out prior to discharging the patient. No patient should be discharged or sent to a medically unsupervised setting (x-ray, clinics, etc.) until his or her mental status has returned to the presedation state. If the patient is transferred prior to the return to presedation mental status, the patient should be accompanied by a nurse.
A standard set of discharge criteria help to ensure safe discharge of the patient. (See Table 8.) Discharge criteria, including level of consciousness criteria, should be met for at least a 30-minute period prior to the patient’s discharge home. The patient should be able to ambulate with assistance consistent with age and prior ambulatory status. The post-procedure and sedation discharge instructions are reviewed once again with the patient and/or responsible party prior to the patient’s leaving the ED.
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Discharge Instructions
Discharge instructions include general warnings regarding decreased mental acuity following sedation, and specific activities to avoid. (See Figure 1.) The patient is warned that the anesthetics used still may be active for 24 hours after the procedure.
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Activity for the patient is minimized during the day following sedation, progressing to regular activities as tolerated. Instructions for avoiding driving cars or operating dangerous machinery or power tools for 24 hours should be given. As examples, instructions can include avoiding sewing machines, blenders, and heavy equipment. Patients are advised not to drink alcohol or take any other sedatives for one day, and not to make important decisions for one day following anesthetics. Caution is advised when climbing or descending stairs. For adults, a diet consisting of clear liquids is best tolerated at first. If the patient has no nausea 6 hours after the procedure, the diet can be advanced as tolerated to solid foods.
For pediatric patients, a similar but more age-appropriate set of instructions is utilized. Parents are advised that their children may feel sleepy, and that sleeping, rest, or quiet play (coloring, watching TV) are recommended activities after sedation. The child’s diet likewise is started with fluids, and advanced as tolerated to the appropriate diet for the child’s age.
Warnings included in discharge instructions request the patient to return or contact the doctor if the patient has persistent vomiting for more than 24 hours, experiences signs of infection such as fever or chills, or if there are any complications from the procedure performed. In children, if the patient has pain unrelieved by acetaminophen or other prescribed pain medication, the patient is warned to return. Table 8 summarizes discharge criteria, and Figure 1 is a sample discharge instruction form.
Quality Assurance and Complications
Adverse events in the ED as a result of sedation and analgesia are multifold, and should be documented both for the patient record and as a part of quality assessment and improvement activities. (See Table 9.) An established quality assurance process helps maintain a high degree of safety and should be an integral part of the ED’s conscious sedation policy. (See Table 10.)
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Conclusion
Procedural sedation enables the emergency physician to perform therapeutic interventions in a safe and humane fashion. As well, sedation enables diagnostic testing to be done accurately and in a controlled setting. As with other interventions, proper use of sedative agents requires screening, preparation, and an ongoing quality monitoring process.
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