Clinical Pearls for Procedural Sedation by Kimberly A. Deady, PharmD; Kelly M. Smith, PharmD; Robert J.

Kuhn, PharmD

This article details several common pharmacological entities, as well as new procedural sedation and analgesia agents and methods currently in use. Orthopedic fracture and joint dislocation are two painful reasons patients present to the emergency department. The success of the physician in performing a joint manipulation or casting a closed fracture can be hindered by patient discomfort. Value exists in techniques that allow for alleviating pain and anxiety of the patient undergoing a low-risk procedure while minimizing adverse effects and recovery time; therefore procedural sedation can be a useful tool to the orthopedic physician. The technique of procedural sedation, previously termed conscious sedation, includes administering sedative or dissociative agents with or without analgesics with the goal of allowing a patient to tolerate an uncomfortable procedure without compromising cardiopulmonary function.1 The phrase conscious sedation has often been used interchangeably in the past with procedural sedation; however, the Joint Commission deemed appropriate terminology procedural sedation and analgesia (PSA) to accurately reflect the spectrum from minimal sedation to general anesthesia.2 With the availability of different agents that have the potential to be used in procedural sedation and analgesia, roles of combination treatment, and with the various adverse effect profiles and pharmacological nuances, understanding the function that each medication plays in procedural sedation and analgesia can be of use to the provider. This article details several common pharmacological entities, as well as new procedural sedation and analgesia agents and methods currently in use. Desirable Properties of PSA Pharmacologic Agents To understand why certain pharmacological agents are routinely used in PSA, desirable pharmacological characteristics must be identified. The agent must allow the patient to be subject to minimal anxiety, pain, and discomfort and experience maximal amnesia during the procedure.3 Procedural sedation and anesthesia should help to control patient behavior to expedite the procedure while minimizing adverse response to treatment. To maximize procedural timeliness, procedural sedation and analgesia agents should have a rapid onset of action, short duration of action, and ease of administration. Given that most narcotic analgesic agents do not possess amnestic properties, they often are used in combination with amnestic agents such as benzodiazepines. Maintenance of muscle tone with little effect on respiratory, cardiovascular or gastrointestinal systems also is a desirable quality.

Narcotic analgesics such as morphine and hydromorphone are not used in procedural sedation and analgesia since they cause histamine release, which potentially compromises hemodynamic stability. The mainstay of procedural sedation and analgesia includes benzodiazepines, fentanyl, barbiturates, nitrous oxide, and ketamine or various combinations of these agents (Table).

Pharmacology of Procedural Sedation Benzodiazepines Among the benzodiazepines, inter-class properties exist that delineate certain agents as far as their use in procedural sedation and analgesia; desirable qualities also include a rapid onset of action, amnestic qualities, and relatively low degrees of phlebitis.3 Midazolam is the benzodiazepine of choice in procedural sedation and analgesia, fulfilling all of the desired characteristics over its classmates, including lorazepam and diazepam. Following slow intravenous administration, midazolam has an onset of action of approximately 2 minutes, a half-life of approximately 2 to 6 hours in healthy adults and metabolism via hepatic hydroxylation and conjugation.4 Midazolam is highly protein-bound so caution must be observed in patients with hypoalbuminemia, as administration could lead to increased sedation with prolonged infusion.5 Of note, benzodiazepines alone do not possess analgesic properties but often are combined with fentanyl; midazolam and fentanyl is one of the most frequently cited combinations of pharmacologic agents used in procedural sedation.3

Oral preparations of midazolam also may be of use in procedural sedation and analgesia, given as a 0.25-0.5 mg/kg (maximum 20 mg) single oral dose 45 to 60 minutes pre-procedurally.6 The oral dose exhibits a significant first pass effect via hepatic metabolism, and is in striking contrast in size to the intravenous or intramuscular dose, where typical maximum doses do not exceed 2.5-5 mg (Table). Doses should be individualized to the patient, especially in the elderly and patients with hepatic impairment, where dose reductions may be necessary.5 Midazolam dosing may need to be reduced up to 30% to 50% when administered concomitantly with other central nervous system (CNS) depressants. Adverse effects of note include midazolams potential for decreases in tidal volume and respiratory rate, nausea, and vomiting.6 Accumulation of repeat doses of midazolam also has been shown to result in a hangover effect.5 Fentanyl Fentanyl is a synthetic opioid and one of the most potent narcotic analgesics. Its usefulness as an analgesic in procedural sedation and analgesia is due to its rapid onset of action (almost immediate when given intravenously, 7 to 8 minutes when given intramuscularly), short duration of action (up to 1 to 2 hours), and lack of effect on histamine release.7 Another benefit to fentanyl is its lack of cross-reactivity in patients with morphine allergy. It, however, lacks amnestic or anxiolytic properties, which is why it often is combined with a benzodiazepine or other agent in procedural sedation and analgesia. Notable adverse effects of fentanyl (>10%) include bradycardia, hypotension, increased intracranial pressure, nausea, vomiting, antidiuretic hormone release, and the potential for chest wall rigidity (especially in neonates) with increased doses.6 Elderly patients may require dose reductions of up to 50%, and dose reduction also should be considered in patients concurrently receiving other central nervous system depressants. Barbiturates Barbiturates frequently are used as a component of combination drug therapy in procedural sedation and analgesia. Several common barbiturates used include pentobarbital, thiopental, and methohexital, with methohexital acting as one of the procedural sedation and analgesia workhorse barbiturates. Methohexital is an ultra-short acting barbiturate anesthetic versus some of its longer acting counterparts, including pentobarbital and phenobarbital, and has a shorter duration of action than thiopental. Following intravenous administration, onset of action of methohexital typically occurs within 30 seconds and effect lasts approximately 2 to 10 minutes.3 Contraindications to methohexital include porphyria and its use as an intra-arterial injection due to the potential for thrombosis.8 The rectal preparation consists of a 25 mg/kg of a 1% solution for induction of anesthesia, along with an intramuscular induction dose of 6.6-10 mg/kg of a 5% solution.8 The manufacturer of Brevital (King Pharmaceuticals, Bristol, Tenn) describes a dosage recommendation for pediatric

patients aged >1 month for rectal administration. However, rectal administration of methohexital likely is infrequently used in practice due to inconvenience in preparation as well as its usual restriction and handling by the anesthesiology department versus the pharmacy department in many institutions. Potential adverse effects attributable to the barbiturate class include central nervous system depression, bradycardia, hypotension, seizure, nausea, vomiting, and laryngospasm; dose reduction should be considered in the elderly.6 Nitrous Oxide Nitrous oxide is an inhaled ultra-short acting dissociative agent that combines sedation and anxiolysis with some analgesic properties. A major benefit of nitrous oxide in procedural sedation and analgesia is its unique administration route versus an intravenous or intramuscular preparation. It appears to mainly act on the central nervous system and requires use in areas equipped with scavenger or recovery systems to avoid inhalation by caregivers.3 Doses used in procedural sedation and analgesia require concomitant administration with 30% oxygen to avoid hypoxia. Nitrous oxide gas produces a peak effect within 3 to 5 minutes after inhalation and recovery occurs after approximately 5 minutes of discontinuation.9 Possible adverse effects of nitrous oxide include nausea and vomiting. Ketamine Similar in theory to nitrous oxide, the introduction of ketamine as a sedative agent has brought the concept of dissociative sedation to the forefront of procedural sedation and analgesia. With dissociative sedation, the goal is for patients to maintain spontaneous respirations and cardiovascular stability. Ketamine is an antagonist of N-methyl-D-aspartate (NMDA) receptors that exhibits an elimination phase lasting approximately 45 minutes, which is roughly equitable to its analgesic period.5 Ketamine causes dissociation between the thalamic and limbic regions of the brain that results in a lack of response to verbal or tactile commands.10 It is associated with a relatively benign cardiovascular and respiratory side effect profile. Emergence phenomena may be associated with the use of ketamine. Emergence reactions may include hallucinations or nightmares and typically are seen as doses escalate or with prolonged use. Post-procedural nausea and vomiting also may be problematic with ketamine. Pediatric Considerations Procedural sedation and analgesia is of equal importance in the pediatric orthopedic population as in the adult population. Of all the agents discussed for procedural sedation and analgesia in the adult population, few additional considerations exist to their roles in pediatrics.

Pentobarbital, over methohexital, is considered to be the barbiturate of choice in children; however, rectal or intramuscular administration of methohexital may be considered for short procedures associated with minimal painful stimuli in pediatric patients.3,8 Ketamine tends to be used more commonly in pediatric patients than adult patients, as children tend to show fewer postprocedure vomiting and emergency reactions.10 Ketamine-midazolam combinations also may be more effective and safer than fentanyl-midazolam combinations for procedural sedation and analgesia in pediatric patients undergoing orthopedic manipulations.9 Dexmedetomidine is an alpha-2 adrenergic receptor agonist that exhibits sympatholytic, analgesic, and sedative properties.11 This agent is able to exert its effect while the patient appears to be asleep but is easily aroused; there are minimal effects on respiratory depression.12 Dexmedetomidine is touted for its other desirable properties as well, including its lack of accumulation, its amnestic effect, and its lack of effect on adrenal steroidogenesis. While it traditionally is used in difficult extubation cases, its use has been demonstrated in a pediatric case series for conscious sedation in difficult awake fiberoptic intubation cases, and its use may translate to general procedural sedation and analgesia practice.11,13 A prospective, randomized trial examined 44 pediatric patients undergoing cardiac catheterization with procedural sedation and analgesia with either dexmedetomidine and ketamine or propofol and ketamine.14 No clinically significant differences were noted in hemodynamics and respiratory variables between groups, yet the dexmedetomidine group was not superior due to a longer recovery time. Several nonpharmacological methods exist that reduce anxiety in children undergoing minor procedures; these include opting for parents at the bedside, allowing for access to a favorite toy or other distraction, and age-appropriate pre-procedural education.15 New Concepts in the Pharmacology of Procedural Sedation Etomidate is an ultra-short acting hypnotic agent that lacks analgesic properties. Its sedative effects are desirable in procedural sedation and analgesia in that its onset of action usually occurs within 1 minute and its duration is approximately 3 to 5 minutes with average adult dosing.16 Etomidate has not been shown to be associated with histamine release; however, transient decreases in plasma cortisol levels have been associated with etomidate at the induction dose. Some authors report that insufficient large-scale trials exist to validate the use of etomidate in the procedural sedation and analgesia population.17 Propofol is a highly lipophilic sedative hypnotic agent that has an onset of action of approximately 40 seconds (the time for one-arm-to brain circulation).18 One of the desirable features of propofol is its rapid half-life of approximately 1 to 3 minutes, translating to the ability to turn it on and off. Caution must be taken to avoid oversedation. Propofol also is associated with minimal dysphoria and emesis, as propofol is also an antiemetic.17

Evidence supports the use of propofol over etomidate based on greater success rates, less incidence of myoclonus and vomiting, and etomidates association with adrenal suppression and decreased cortisol levels.19 Fospropofol (Aquavan; MGi Pharma, Bloomington, Minn) is a water-soluble prodrug of propofol currently in clinical trials for mild to moderate sedation. Benefit with fospropofol may be seen with its water solubility and more predictable pharmacodynamics versus propofol. However, its clinical use in procedural sedation and analgesia remain to be seen, as it exhibits a longer elimination half-life, larger volume of distribution, and slower onset of action than propofol.5 Procedural Sedation and Anesthesia Monitoring Regardless of the agent used, monitoring of the patient remains an essential component of procedural sedation and analgesia. The SOAPME acronym represents a systematic approach to procedural sedation and analgesia; it stands for suction, oxygen, airway, pharmacy, monitors, and equipment.20 It reminds the practitioner to have on hand appropriate catheters for suction, adequate oxygen supply, patient-appropriate airway-equipment, medication necessary for the procedure, pulse-oximeters, blood pressure, and cardiac monitors, and other potentially lifesaving equipment, ie, a defibrillator. Complete patient history is important in determining comorbidities prior to procedural sedation and analgesia.3 While pulse-oximetry use in patients at high risk for hypoxia during procedural sedation and analgesia remains a level B recommendation by the American College of Emergency Physicians, capnometry remains a level C recommendation, and Bispectral Index lacks evidence to support its use in procedural sedation and analgesia.1 Administration of procedural sedation and analgesia should always be conducted in an appropriate setting that allows for continuous supervision of the patient by trained medical staff.21,22 The Bottom Line

Ideal procedural sedation and anesthesia agents minimize anxiety, pain and discomfort while maximizing amnesia surrounding the procedure. Procedural sedation and anesthesia usually requires combinations of multiple agents to reach desired effects of analgesia plus anxiolysis. Desirable characteristics of the agents used in PSA include rapid onset of action, short duration of action, maintenance of muscle tone, and minimal adverse effects. Elderly patients typically will require a dose reduction from the standard adult dose (standard adult doses are listed in the Table). Appropriate monitoring includes level of consciousness documentation (via validated rating scales), pulse oximetry, cardiac

monitoring, and potentially capnometry.

References 1. Goodwin SA, Caro DA, Wolf SJ, and the American College of Emergency Physicians. Clinical policy: procedural sedation and analgesia in the emergency department. Ann Emerg Med. 2005; 45:177-196. 2. Green SM, Krauss B. Procedural sedation terminology: moving beyond conscious sedation. Ann Emerg Med. 2002; 39:433-435. 3. Bahn EL, Holt KR. Procedural sedation and analgesia: a review and new concepts. Emerg Med Clin North Am. 2005; 23:503-517. 4. Midazolam prescribing information. Ontario, Canada: Novex Pharma; 2000. 5. Gan TJ. Pharmacokinetic and pharmacodynamic characteristics of medications used for moderate sedation. Clin Pharmacokinet. 2006; 45:855-869. 6. Lacy CF, Armstrong LL, Goldman MP, Lance LL. Drug Information Handbook. 13th ed. Hudson, Ohio: Lexi-Comp; 2005. 7. Fentanyl (Sublimaze) prescribing information. Decatur, Ill: Taylor Pharmaceuticals; 2005. 8. Methohexital (Brevital) prescribing information. Albuquerque, NM: Monarch Pharmaceuticals; 2002. 9. Kennedy RM, Porter FL, Miller JP, Jaffe DM. Comparison of fentanyl/midazolam with ketamine/midazolam for pediatric orthopedic emergencies. Pediatrics. 1998; 102(4 Pt 1):956-963. 10. Loh G, Dalen D. Low-dose ketamine in addition to propofol for procedural sedation and analgesia in the emergency department. Ann Pharm. 2007; 41:485-492. 11. Bergese SD, Khabiri B, Roberts W, Howie MB, McSweeney, TD, Gerhardt MA. Dexmedetomidine for conscious sedation in difficult awake fiberoptic intubation cases. J Clin Anesth. 2007; 19:141-144. 12. Coursin DB, Coursin DB, Maccioli GA. Dexmedetomidine. Curr Opin Crit Care. 2001; 7:221-6. 13. Tobias JD. Dexmedetomidine: applications in pediatric critical care and pediatric anesthesiology. Pediatr Crit Care Med. 2007; 8:115-131. 14. Tosun Z, Akin A, Guler G, Esmaoglu A, Boyaci A. Dexmedetomidine-ketamine and propofol-ketamine combinations for anesthesia in spontaneously breathing pediatric patients undergoing cardiac catheterization. J Cardiothorac Vasc Anesth. 2006; 20:515519. 15. Merritt KA, Sargent JR, Osborn LM. Attitudes regarding parental presence during medical procedures. Am J Dis Child. 1990; 144:270-271. 16. Etomidate prescribing information. Bedford, Ohio: Bedford Laboratories; 2004. 17. Green SM, Krauss B. Propofol in emergency medicine: pushing the sedation frontier. Ann Emerg Med. 2003; 42:792-797. 18. Propofol prescribing information. Bedford, Ohio: Bedford Laboratories; 2005. 19. Green SM. Research advances in procedural sedation and analgesia. Ann Emerg Med. 2007; 49:31-36.

20. American Academy of Pediatrics; American Academy of Pediatrics, Cote CJ, Wilson S; Work Group on Sedation. Guidelines for the monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: an update. Pediatrics. 2006; 118:2587-2602. 21. Hogan K, Sacchetti A, Aman L, Opiela D. The safety of single-physician procedural sedation in the emergency department. Emerg Med J. 2006; 23:922-923. 22. Warrillow S, Bellomo R, Jones D. Conscious sedation on a general ward: the MET and clinical governance. Jt Comm J Qual Patient Saf. 2007; 33:112-117. Authors Dr Deady is from the University of Kentucky HealthCare, Dr Smith is from the University of Kentucky College of Pharmacy, and Dr Kuhn is from the University of Kentucky Colleges of Pharmacy and Medicine, Lexington, Ky. Correspondence should be addressed to: Robert J. Kuhn, PharmD, University of Kentucky HealthCare, Dept of Pharmacy Services, 800 Rose St, H-110, Lexington, KY 40536-0293. The ORTHOSuperSite is intended for physician use and all comments will be posted at the discretion of the editors. We reserve the right not to post any comments with unsolicited information about medical devices or other products. At no time will the ORTHOSuperSite be used for medical advice to patients. There are no comments for this article. Be the first to comment. Your comment Name:

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Return to Contents

PROCEDURAL SEDATION

Indications

Procedural sedation is a clinical technique that creates a decreased level of awareness for a patient yet maintains protective airway reflexes and adequate spontaneous ventilation. The goals of procedural sedation are to provide analgesia, amnesia, and anxiolysis during a potentially painful or frightening procedure. Pharmacologic agents used in procedural sedation are of three general classes: sedatives, analgesics, and systemic agents. Using a combination of a sedative/analgesic provides a synergistic combination that generally gives consistent clinical results; using systemic agents provides very rapid sedation and relaxation with some analgesia. Patients should be NPO for at least 4-6 hours prior to procedure if at all possible. Patients should be triaged to the appropriate Physical Status Classification before conscious sedation is performed:

Class I: Normally healthy Class II: Patient with mild systemic disease (e.g. hypertension) Class III: Patient with severe systemic disease (e.g. CHF), non-decompensated Class IV: Patient with severe systemic disease, decompensated Class V: Moribund patient, survival unlikely

Procedural sedation is appropriate for patients in Classes I, II and III. Patients in classes IV and higher are better suited for the OR.

Procedures appropriate for procedural sedation include ANYTHING painful: debridement of wounds, placement of central lines, chest tube placement, abscess drainage, reduction of fractures and dislocations.

Contraindications

1. 2. 3. 4.

Recent (<2 hr) ingestion of large food or fluid volumes Physical class IV or greater Lack of support staff or monitoring equipment Lack of experience/credentialing on part of clinician

Materials

1. 2. 3. 4.

Monitoring equipment: BP cuff, pulse oximeter, cardiac monitor IV access Oxygen delivery by nasal prongs or mask Resuscitation equipment: Endotracheal tubes, Ambu bag and mask, defibrillator, emergency cardiac drugs, naloxone, flumazenil Personnel trained in airway management, and recovery of sedated patients Informed consent as appropriate

5. 6.

Medication combinations for conscious sedation:

1. 2. 3.

Ketamine, atropine (or glycopyrrolate), and benzodiazepine Benzodiazepine and analgesic Systemic agents (propofol or etomidate) and analgesic

Preprocedure patient education

1.

Discuss with the patient/parent(s)/guardian the need for sedation in light of the presenting clinical situation Obtain informed consent Explain the major steps of procedural sedation Inform the patient of the possibility of transient unpleasant sensations of pain, nausea, dizziness; stress benefits of improved comfort, relaxation, and analgesia

2. 3. 4.

NOTE: Procedural sedation should be appropriate to the procedure being performed. A laceration on a child may require only ketamine, whereas a hip dislocation on an obese adult probably requires a systemic agent and analgesic for proper sedation and relaxation.

Procedure

Using Ketamine, atropine and a benzodiazepine -this is an excellent combination for children under 11 years of age. Older children and adults do not require the addition of atropine. -emergence reactions are more common in adults, and combination treatment with a benzodiazepine may alleviate this -ketamine is an excellent sedation agent for asthmatics, as it does not cause airway hyperreactivity

Time

0 +1 minute

Attach monitoring equipment and obtain baseline readings Ketamine 1-2 mg/kg IV OR 3-5 mg IM, PLUS atropine 0.01 mg/kg IV/IM, OR gylcopyrrolate 0.005 mg/kg IM/IV PLUS midazolam 0.05 mg/kg IV/IM

+5-10 min +30-120 min

Begin procedure Recover patient

Using Analgesic and a benzodiazepine

Time

0 +1 minute

Attach monitoring equipment and obtain baseline readings fentanyl 0.001-0.002 mg/kg IV OR morphine 0.1-0.2 mg IV, PLUS midazolam OR lorazepam 0.05 mg/kg IV Begin procedure Recover patient

+3-5 min +10-120 min

Using a systemic agent and an analgesic

Time

0 +1 minute

Attach monitoring equipment and obtain baseline readings Propofol 1-2 mg/kg IV OR etomidate 0.3 mg/kg IV, PLUS morphine 0.05 mg/kg IV (NOTE THE LOWER DOSE OF ANALGESIAthis is due to the synergistic effect of the anesthetic) Begin procedure

+3-5 min

+10-120 min

Recover patient

Reversal of Sedation

Rarely should reversal of agents used in procedural sedation be necessary if they are titrated appropriately.

Naloxone is a competitive antagonist of the opioid receptors; it is used for reversal of narcotic analgesics. Use 0.001 mg/kg IM/IV titrated to effect. Be aware that the duration of naloxone is less than the duration of action for most opiates. Be prepared to re-bolus the naloxone, or use a naloxone drip at .01-.05 mg/min.

Flumazenil is a pure benzodiazepine antagonist, and can be used for reversal of benzodiazepine sedation. Like naloxone, it has a shorter duration of action than the benzodiazepine agents it reverses. Prepare to re-bolus with flumazenil, or run a flumazenil drip at 0.1 mg/min. Use 0.2 mg IV every 2-5 minutes titrated to effect, or up to 2-3 mg in total if needed.

Complication, Prevention, and Management

1. a.

Inadequate amnesia or analgesia: Dosage of amnesic or analgesic agents are based upon patient weight. Make sure weights are accurate, and dosages are adequate. As a general rule, the elderly need less, muscular young men need more, and agitated children may also require slightly more medication.

b.

Allow sufficient time for the agents to work. It is tempting to start the procedure(s) immediately upon drug administration, but do allow time to titrate the effect of the sedation medications.

2.

Decreasing oxygen saturation: apply nasal cannula or a non-rebreather mask for increased oxygenation. Occasionally, a bag-valve-mask with positive pressure ventilation may be required transiently. Prolonged recovery: prolonged offset of sedation is dependent on several factors of which the most important are drug distribution in the patient, and the patients own clearance of the sedation agents. Be prepared to recover the patient for a prolonged period, with adequate oxygenation and clearance of any airway secretions.

3.

Documentation in the medical record

1. 2. 3. 4. 5.

Consent (obtain if possible) Indications and any contraindications for the procedure; ASA physical classification Medications used, and dosages Any complications of none Who was notified of any complications (family, attending MD)

NOTE: Many hospitals have an institutional conscious sedation record which fulfils most of the above criteria.

Items for evaluation of the person performing this procedure

1. 2.

Indications and contraindications for conscious sedation Pharmacology of commonly used agents, and their indications in appropriate situations

3. 4. 5.

Understanding recovery of patients Understanding possible failure of the procedure and why Appropriate documentation

http://apps.med.buffalo.edu/procedures/conscioussedation.asp?p=8

Conscious sedation for surgical procedures

Conscious sedation is a combination of medicines to help you relax (a sedative) and to block pain (an anesthetic) during a medical or dental procedure. You will probably stay awake but may not be able to speak. Conscious sedation lets you recover quickly and return to your everyday activities soon after your procedure.

Description
A nurse, doctor, or dentist, will give you conscious sedation in the hospital or outpatient clinic. Most of the time, it will not be an anesthesiologist. The medicine will wear off quickly, so it is used for short, uncomplicated procedures. You may receive the medicine through an intravenous line (IV, in a vein) or a shot into a muscle. You will begin to feel drowsy and relaxed very quickly. If your doctor gives you the medicine to swallow, you will feel the effects after about 30 to 60 minutes. Your breathing will slow down, and your blood pressure may drop a little. Your nurse or doctor will monitor you every 3 to 5 minutes during your procedure to make sure you are okay. This person will stay with you at all times during the procedure. You should not need help with your breathing, but you may receive extra oxygen through a mask or IV fluids through a catheter (tube) into a vein. You may fall asleep, but you will wake up easily to respond to people in the room. You may be able to respond to verbal cues. After conscious sedation, you may feel drowsy and not remember much about your procedure.

Why the Procedure is Performed

Conscious sedation is safe and effective for patients who need minor surgery or a procedure to diagnose a condition. Some of the tests and procedures conscious sedation may be used for are:

Breast biopsy Dental prosthetic or reconstructive surgery Minor bone fracture repair Minor foot surgery Minor skin surgery Plastic or reconstructive surgery Procedures to diagnose and treat some stomach (upper endoscopy), colon (colonoscopy), lung (bronchoscopy), and bladder (cystoscopy) conditions

Risks
Conscious sedation is usually safe. However, if you are given too much of the medicine, problems with your breathing may occur. A doctor or nurse will be watching you during the whole procedure. Health care providers always have special equipment to help you with your breathing, if needed. Onlhy certain qualified health professionals can provide conscious sedation.

Before the Procedure

Always tell your doctor or nurse:

If you are or could be pregnant What drugs you are taking, even drugs, supplements, or herbs you bought without a prescription

During the days before your procedure:

Tell your doctor about any allergies or health conditions you have, what medicines you are taking, and what anesthesia or sedation you have had before. You may have blood or urine tests and a physical exam. Arrange for a responsible adult to drive you to and from the hospital or clinic. If you smoke, try to stop. Ask your doctor or nurse for help quitting.

On the day of your procedure:

You will usually be asked not to drink or eat anything after midnight the night before your procedure. Do not drink alcohol the night before and the day of your procedure. Take the drugs your doctor told you to take with a small sip of water. Your doctor or nurse will tell you when to arrive at the hospital or clinic.

After the Procedure

After conscious sedation, you will feel sleepy and may have a headache or feel sick to your stomach. During recovery, yur finger will be clipped to a special device (pulse oximeter) to check the oxygen levels in your blood. Your blood pressure will be checked with an arm cuff about every 15 minutes. You should be able to go home 1 to 2 hours after your procedure. When you are home:

Eat a healthy meal to restore your energy. You should be able to return to your everyday activities the next day. Avoid driving, operating machinery, drinking alcohol, and making legal decisions for at least 24 hours. Check with your doctor before taking any medicines or herbal supplements. If you had surgery, follow your doctors instructions for recovery and wound care.

Outlook (Prognosis)
Conscious sedation is generally safe, and is an option for procedures or diagnostic tests.

Alternative Names
Anesthesia - conscious

References
Jagannath S, Baron TH, Anderson MA, et al. Sedation and anesthesia in GI endoscopy. Gastrointestinal Endoscopy. Aug 2008;68(2). Cohen NA, Stead SW. Moderate sedation for chest physicians. Chest. June 2008;133(6). Sherwood ER, Williams CG, Prough DS. Anesthesiology principles, pain management, and conscious sedation. In: Townsend CM, Beauchamp RD, Evers BM, Mattox KL, eds. Sabiston Textbook of Surgery. 18th ed. Philadelphia, Pa: Saunders Elsevier; 2008:chap 18.

Update Date: 1/26/2011

Updated by: Shabir Bhimji, MD, PhD, Specializing in General Surgery, Cardiothoracic and Vascular Surgery, Midland, TX. Review provided by VeriMed Healthcare Network. Also reviewed by David Zieve, MD, MHA, Medical Director, A.D.A.M., Inc.
Browse the Encyclopedia

MedlinePlus Topics

Anesthesia

Read More

General anesthesia

Patient Instructions

Anesthesia - what to ask your doctor - adult Anesthesia - what to ask your doctor - child

http://www.anesthesia-analgesia.org/content/99/5/1355.full

Review of Pediatric Sedation

1. Joseph P. Cravero, MD and 2. George T. Blike, MD

+ Author Affiliations 1. Department of Anesthesiology, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire
1. Address correspondence and reprint requests to Joseph P. Cravero, MD, Department of Anesthesiology, Dartmouth Hitchcock Medical Center, One Medical Center Dr., Lebanon, NH 03756. Address e-mail to Joseph.Cravero@Hitchcock.org.

Next Section

Abstract
Sedating children for diagnostic and therapeutic procedures remains an area of rapid change and considerable controversy. Exploration of this topic is made difficult by the fact that the reports of techniques and outcomes for pediatric sedation appear in a wide range of subspecialty publications and rarely undergo comprehensive examination. In this review article, we will touch on many aspects of the topic of pediatric sedation from the perspective of the anesthesiologist. We begin with a review of the historical role of anesthesiologists in the development of the current standards for pediatric sedation. We also examine the current status of pediatric sedation as reflected in published studies and reports. A specific review of the issues surrounding safety of sedation services is included. Current trends in sedation practice, including the expanding role of potent sedative hypnotic drugs outside the field of anesthesiology, are noted. Finally, we suggest future areas for research and clinical improvement for sedation providers. Sedating children for diagnostic and therapeutic procedures has engendered debate both within and between the myriad of pediatric specialists who provide this service. In hospitals across the United States, there is little agreement as to which medications, techniques, practice settings, or even personnel should be involved in its delivery. Confounding any discussion of solutions to this quandary is the fact that there has been scant discussion as to what defines success (or best practice) in sedating children. Furthermore, few aspects of anesthesia practice lead to as much confusion over the exact role of the pediatric anesthesiologist. (It is interesting to note that when the New England Journal of Medicine published a review article on pediatric sedation, it was written by two emergency medicine physicians (1).) Perhaps now more than ever, reflection is required on the state of the art of pediatric sedation and the key areas where anesthesiologists can function to help optimize its safety and efficacy. In this review, we will seek to examine the past role of anesthesiologists in shaping the field of pediatric sedation, the current status of pediatric sedation as reflected by the literature, and goals for improving future practice.
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The Historical Role of Anesthesiologists

Reports relating to specific involvement by anesthesiologists in pediatric sedation are rare before the early 1980s. Arguably, the most significant contribution of our specialty has been in the development of sedation guidelines, which subsequently became international standards. The first monitoring guideline for sedation was written by Dr. Charles Cot and Dr. Theodore Striker in 1983 (published in 1985) while working on behalf of the American Academy of Pediatrics (AAP) Section on Anesthesiology. This guideline was written in response to reports of three deaths in a single dental office and other concerns primarily involving dental sedation (2). Written with the cooperation of the American Academy of Pediatric Dentistry and the American Society of Anesthesiologists (ASA), the purpose of the guidelines was to develop a framework from which improved safety could be developed for children requiring sedation to perform a required procedure (3,4). The guideline emphasized systems issues, such as the need for informed consent, appropriate fasting before sedation, frequent measurement and charting of vital signs, the availability of age and size appropriate equipment, the use of physiologic monitoring, the need for basic life support skills, and proper recovery and discharge procedures. The concept of an independent observer whose only responsibility was to monitor the patient was introduced for deeply sedated pediatric patients. Advanced airway and resuscitation skills were encouraged but not required. Finally, these original guidelines defined three terms for depth of sedation: conscious sedation, deep sedation, and general anesthesia. The descriptive term conscious sedation was defined as, A medically controlled state of depressed consciousness that allows the protective reflexes to be maintained; retains the patients ability to maintain a patent airway independently and continuously; and permits an appropriate response by the patient to physical stimulation or verbal command, e.g., open your eyes. In retrospect, the choice of this terminology was unfortunate, because this condition is rarely attained in sedated children, and its use led to confusion and promoted practices that were not intended by the original guideline. In 1992, the Committee on Drugs of the AAP (primary author Dr. Cot) revised the 1985 guideline (5). This new iteration clearly stated that a patient could readily progress from one level of sedation to another and that the practitioner should be prepared to increase vigilance and monitoring as indicated. Pulse oximetry was recommended for all patients undergoing sedation. This new guideline also discouraged the practice of administering sedation at home by parents a practice that was not infrequent in dental and radiologic sedation at that time. An amendment to this guideline was produced by the same Committee on Drugs of the AAP 2002 (6). It eliminated the use of the term conscious sedation and clarified the fact that these guidelines apply to any location where children are sedated, including in or out of the hospital. The current guidelines use the terminology of minimal sedation, moderate sedation, deep sedation, and anesthesia. This language is consistent with that used by the ASA and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (7). Contemporaneous with the guideline development described above, other organizations including the American Academy of Pediatric Dentistry and the American College of Emergency Physicians wrote their own guidelines for sedation (8,9). These guidelines were at odds with the AAP/ASA guidelines in some respects, perhaps most importantly in their definition of sedation levels themselves. The result has been considerable confusion when practitioners or regulatory requirements overlap. Whereas the situation will not be resolved quickly, the AAP guidelines are

once again being revised, and dialogue with these organizations has been initiated toward the goal of a unified nomenclature and consistent recommendations for pediatric sedation.
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Current Status Evaluation

It is difficult to fully comprehend the current status of pediatric sedation because the reports concerning this practice are published in such a wide range of journals, and the outcome measures used vary so greatly. What we do know is that each year, millions of infants and children require sedation and pain control for medical procedures. Hospitals and offices struggle with the logistical and medical difficulties associated with providing this service. There is often heavy demand for pediatric sedation services throughout the usual work day as well as off hours, and these cases must be performed in a wide variety of locations involving many different services, including radiology, dentistry, pediatric inpatient service, emergency department, and nuclear medicine. The difficulty in meeting these demands was pointed out in a study that found centers in the United States were much less likely to offer sedation for painful procedures than similar centers in Europe (10). Thirty percent of US respondents to this mail survey reported performing bone marrow biopsies in children without significant sedation more than 50% of the time as compared with 0% of European centers. Attempts to accommodate the need for pediatric sedation have led to the formulation of a wide variety of possible solutions. Some sedation services have opted for direct physician involvement, whereas others are directed by trained nursing personnel (1113). Still, others have developed the concept of a sedation room or a sedation team combining provider types (1418).

Outcomes
When sedation is attempted for pediatric procedures, the reported efficacy of the various sedation system options differs considerably. The major goals of pediatric procedural sedation may vary with the specific procedure, but generally encompass anxiety relief, pain control, and control of excessive movement. The rate of failure to achieve these goals has been reported by various investigators to be as infrequent as 1%3% (1922) and by others to be as frequent as 10%20% (2328). Success rates not only depend on the setting (including the provider) and the type of procedure that is being performed, but also on the definition used for adequate or successful sedation. In most published studies, any sedation regimen that allows a procedure to be completed is counted as successful (29). We are rarely informed of the condition of the patient during the procedure or during the recovery period. In this way, a child who is given a dose of oral midazolam and cries or screams during a lumbar puncture and then sleeps for 2 h is considered an equal success as the patient who lies perfectly still under brief propofol sedation, although objective observers would clearly count one strategy a success and the other a failure. When sedation fails, procedures are performed on children who are crying, struggling, and requiring significant restraint. This situation leads to unwanted stress in the child and family, adverse procedure outcomes, and care that is generally less effective (30).

Theroux et al. (27) described the common practice of suturing children who have lacerations without sedation using only local anesthesia and papoose boards to restrain noncompliant patients. As expected, adding sedation dramatically reduced crying and struggling and increased parental satisfaction. Similarly, Stokland et al. (31) documented decreased stress (and increased satisfaction) in a cohort of patients undergoing voiding cystourethrogram studies. Kain et al. (32) found inadequate preoperative sedation was clearly linked to anxiety in children and their families surrounding surgical procedures. Even more concerning, these investigators documented that 54% of children undergoing stressful anesthesia induction have postoperative maladaptive behaviors. Furthermore, they found that the incidence of these behaviors could be decreased through the use of appropriate sedation. Similar findings of post-traumatic stress syndrome have been documented in a population of children after hospitalization with repeated invasive procedures (33). Diagnostic procedure quality suffers when suboptimal sedation leaves movement uncontrolled, particularly in radiology practice. Malviya et al. (34) have reported clear improvement in the quality of magnetic resonance imaging (MRI) scans performed using anesthesia as compared with moderate sedation. In addition, when movement is grossly excessive, procedures must often be rescheduled with an expert sedation service providing the sedation. This logically leads to significant increases in cost of the procedure because of lost time in the scanner and lost work time for care providers. Multiple centers report cancellation rates as much as 15% for radiological procedures (MRIs, CT scans, etc.) in children because of excessive movement (23,24,35). Rates of failure in this setting decrease dramatically when sedation is provided by a dedicated team, by implementing clear protocols (28,36), or when anesthesiologists provide sedation (37). The manner in which length of duration of sedation matches the requirements for a procedure must also be considered in evaluating the success of a sedation technique. A case in point is the (still very) common use of chloral hydrate for CT scans or other brief procedures (26,3840). Whereas many reports catalog successful completion of studies without injury to patients, one must ask whether 60150 min of sedation is appropriate for a 5-min study. Perhaps even more important are the delayed side effects described by Malviya et al (41). These investigators found restlessness and agitation lasting more than 6 h in one-third of children undergoing neuroimaging with chloral hydrate sedation, 5% of whom did not return to their baseline activity for 2 days after their procedure. The financial implications of lost workdays for parents and return visits to emergency departments have never been fully considered in studies of long-acting sedatives used for brief procedures.

Trends
Pediatric sedation practice extends over a diverse group of medical specialties (anesthesiology, intensive care medicine, emergency medicine, and radiology) and provider types (registered nurse [RN], advanced registered nurse practitioner, certified registered nurse practitioner, physician assistant, and MD). Whereas this makes definitive statements about the direction of current practice difficult, we believe several trends are evident:

1. Propofol sedation delivered by nonanesthesiologists is a growing practice across the country. This is particularly true in the intensive care environment and the emergency department. Most of the literature regarding this practice is found in the intensive care literature, where the virtues of propofols rapid onset and recovery are extolled. A common model that is being promoted is that of the intensive care unit (ICU) sedation team headed by an intensivist using some portion of the pediatric ICU to run a pediatric sedation service (17,4244). This practice is made more attractive by the fact that many of these practitioners can be credentialed in the hospital to deliver this care and will bill under anesthesia codes (45). Other models, such as the initiation of propofol sedation in the ICU and sending patients with RN monitors to other locations in the hospital have also been reported (14). Use in dentistry, oral surgery, endoscopy, and radiology has also been advocated by nonanesthesiologists (25,35,4651). Two new studies describe the use of propofol for procedural sedation by emergency physicians (52,53). All of these reports are notable for the fact that they represent nonanesthesiologists informing other nonanesthesiologists on the proper technique for administering propofol. Their recommendations for use and treatment of minor side effects are not always in line with those of anesthesiologists (54). 2. Although it is certainly not a new drug, ketamine sedation has experienced a resurgence in popularity, particularly in the emergency departmentif published studies and reports are any indication of practice. IM and IV ketamine (with and without midazolam) are favorite strategies for accomplishing closed fracture reductions and other painful minor procedures in this setting (19,5563). Authors site the lack of respiratory depression and the maintenance of airway reflexes as great advantages for ketamine over other sedation options. Its effectiveness in producing adequate sedation for painful procedures is excellent. However, postsedation nausea and vomiting, emergence reactions, and infrequent episodes of laryngospasm continue to be cited (6466) with its use. Leading proponents of the use of ketamine suggest that it should be considered in its own separate category of sedationdissociative sedationand that guidelines concerning its use should reflect this unique nature (67). 3. Led by emergency physicians, the applicability of nil per os (NPO) guidelines, which have been propagated for pediatric sedation as an extension of anesthesia practice, have been called into question (6870). Although the largest prospective or retrospective studies involving this practice are still relatively small (1500 patients), the authors point out that there seems to be little evidence for patient harm. In addition, these investigators point out that there are no case reports of aspiration during pediatric sedation in the emergency department, regardless of NPO status. These studies drive home the fact that sedation of nonfasted children is commonplace in the emergency department setting, and publication of prospective data on the outcomes of this practice may ultimately impact thinking on this issue for elective sedation. 4. Finally, a review of the current literature reveals that specialists outside of anesthesiology continue to expand their repertoire of medications used for pediatric sedation to include those normally associated with general anesthesia, attaining depths of sedation that undoubtedly reach this level. The published literature outside of anesthesiology is replete with descriptive or randomized studies of small numbers of patients undergoing procedures with one deep sedation regimen or another (17,43,46,52,71,72). At the same time, reports of sedation experience and innovation are relatively rare in the anesthesia literature, probably because this work is considered so routine as to not be worthy of reporting. The result is the perception by other

medical specialists that pediatric sedation is evolving into the domain of intensivists and emergency medicine specialists, where anesthesiologists are experts in the operating room domain.

Current Sedation Strategies

Pediatric sedation technique should ideally be customized for the patient and the procedure to be performed. For example, a distinction should be made as to whether the procedure will involve significant discomfort. Nonpainful procedures, such as MRI scans or nuclear scans, are best accomplished with a rapid acting pure sedative such as propofol. The effectiveness and smooth recovery characteristics of this drug are familiar to anesthesiologists and without peer for this application. Indeed it is the clear advantages of propofol that have caused nonanesthesiologists to gravitate toward its use, despite concerns about monitoring and airway management skills. Alternatively, for painful procedures such as a bone marrow biopsy, procedural conditions are improved by the addition of an analgesic component such as a small dose of fentanyl, infusion of remifentanil, or the use of ketamine as a sedation adjunct. Additionally, patient factors, such as hemodynamic instability because of cardiomyopathy, make the choice of a drug such as etomidate preferable to propofol in some instances. Finally, the personnel involved in monitoring and delivering pediatric sedation will influence the choice of sedation drug. When anesthesiologists are delivering sedation, any of the currently available sedative hypnotics and analgesics can be brought to bear on a given case. When a sedation system is configured with nurse providers, drugs with a very wide safety margin, such as chloral hydrate and pentobarbital, are usually selected. As mentioned above, the willingness and ability of nonanesthesiologist MDs to use potent sedative hypnotics is an area of evolution at this time, but the published trend is clearly toward expansion of the use of these drugs outside of anesthesiology (17,43,46,52,71,72). With these caveats in mind, we have constructed Table 1(7388) to represent some of the most common current strategies for sedation of children. This is not meant to be an all-inclusive listing, but rather it is a catalog of the most common medications for sedation based on literature review, discussion with colleagues, and personal experience.
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Table 1. Sedation Regimens for Children Of course, any of the painful procedures mentioned could be accomplished through the use of potent inhaled anesthetics. There is one recent study (30) that showed improved satisfaction and procedural conditions when general anesthesia was used instead of midazolam for moderate sedation for painful oncology procedures. Whereas this is always an option, inhaled anesthesia, which requires the use of an anesthesia machine and appropriate scavenging equipment, can lead

to undesired emergence phenomena (89). For the purposes of this review, we will focus on sedation delivered by other routes and include only nitrous oxide for inhalation. Note: We have not included a discussion of local anesthetics; their use is very important for any procedural sedation provider. Appropriate application of local anesthesia may allow pure sedative use for an otherwise painful procedure because it may constitute the analgesic component of the sedation plan. Large doses of local anesthetics may have their own sedating effects and add to the sedation that is produced by other drugs and deepen the sedation level achieved.
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Safety Issues in Pediatric Sedation

Statistics
The safety of pediatric sedation practice has proven difficult, if not impossible, to assess with prospective studies. There are simply no large, sufficiently powered, multicentered trials to evaluate safety in this context. Instead, the literature is replete with descriptions of how sedative medications can be used in a variety of settings on a series of patients (usually less that 200 in a cohort) without a fatality (38,51,55,76,79,90). Given that the expected incidence of a sedationinduced crisis should be on the order of 1 in tens of thousands, it is not surprising that these studies rarely uncover a critical event. In fact, if a study were designed to detect a difference between one sedation method with a fatality rate of one in 5000 compared to another method with a fatality rate of one in 20,000, the study would require more than 50,000 patients in each group. Efforts to detect safe or unsafe practice from epidemiological studies will require large cooperative databases that have the power to detect (what should be) rare events. Alternatively, techniques are required that will reveal much more detail of our current practice and investigate the potential impact (or lack of importance) of desaturation events or other minor complications.

Defining Safety in the Context of Pediatric Sedation

In addition to these statistical difficulties, we must define the nature of safety and what constitutes complications. Science has taught us that error and failure in complex systems can be thought of in terms of accomplishing the work goal and avoiding or managing side effects. The focus on sedation safety tends to be directed towards how often a sedative drug produces an unwanted side effect or toxicity. In this context, the most serious complication of pediatric procedural sedation, death, is most often caused by the unmanaged respiratory depressant side effect of sedative medications. Although an incidence of death or permanent neurological injury during pediatric sedation is impossible to calculate because of a lack of data, evaluation of the published literature on pediatric sedation indicates that these events are rare (29). However, sedation is a prevalent situation (millions of children receive sedation annually) (91). In their often-cited retrospective studies, Dr. Charles Cot et al. reviewed 95 cases of sedation-related deaths and critical incidents derived from the Food and Drug Administrations adverse drug

event reporting system from the US Pharmacopeia and from a survey of pediatric specialists (92,93). Their analysis revealed that (rather than being related to a specific medication) the overwhelming majority of critical events were preventable and caused by operator error or lack of robust rescue systems when incidents occurred. Whereas many of the incidents cited in this study occurred over 20 years ago, and therefore predated the implementation of AAP sedation guidelines, the findings in this study were similar to those in all high-risk fields and are likely applicable today. In fact, even when clinicians adhere to current practice guidelines for pediatric procedural sedation, there is risk of iatrogenic injury. One study prospectively followed 1140 children (age, 2.96 3.7 yr) sedated for procedures by nonanesthesiologists following AAP guidelines and using a quality assurance tool. Approximately 13% of the children received inadequate sedation. They also reported a 5.3% incidence of respiratory events, including one in which a child stopped breathing (23). Most prospective studies of sedation practice available at this time do little to clarify what is meant by safety in pediatric sedation. Authors will invariably cite the incidences of hypotension, hypoxia, and airway obstruction (and interventions required to reestablish normoxia or normotension). However, as long as no child is critically injured (or dies) during the study, the conclusions are that their technique is safe and effective (42,51,65,78,94). Despite the lack of patient injury or death, a detailed examination of the data from some of these studies calls these conclusions into question. Is the requirement to bag-mask 10% of patients and intubate 1% of patients consistent with a safe technique, or does this indicate that rescue systems in that institution are particularly robust? (43) Safety can only be implied for the setting in which these studies have taken place. In most cases, these are large teaching hospitals with copious and readily available assistance. In different settings with less robust rescue systems, the outcomes from these events could be much more concerning. Sedation is not a primary therapy but rather a treatment of procedural side effects, such as pain, anxiety, and dangerous movement. Failure to treat these side effects with adequate sedation may help the provider avoid respiratory depression but results in accomplishing the procedure through physical restraint. As reviewed in the Outcomes section of this paper, whereas no child may die of their pain or stress during a procedure, the psychological injury that accompanies this type of error remains an unwanted (unsafe) outcome of the care provided. We remember the historical record of when surgery was performed before the invention of adequate anesthesia. In many instances, the psychological trauma was severe, and in many cases, patients refused required surgery. Whereas the psychological trauma associated with unsedated bone marrow aspiration, lumbar puncture, and urinary catheter placement on children has not been quantified, posttraumatic stress disorder has been well documented in children experiencing trauma in the hospital setting (95,96). In addition, it is logical that the safety of a given procedure may be compromised when the operative conditions are poor. For example, a thrashing, crying child receiving intrathecal chemotherapy is at increased risk for extradural injection. In this safety framework, we strongly advocate that sedation providers define as inadequate or failure any sedation that results in patients who are in severe distress during a procedure.

Simulation

Human simulation offers an extremely promising technology in the promotion of pediatric sedation safety. As with other industries that face high-risk, infrequent events, simulators can be extremely helpful in recreating rare clinical situations and testing the response of individuals and systems to rescue patients who are in respiratory or cardiovascular arrest (9799). At Dartmouth Hitchcock Medical Center, we have piloted the use of the pediatric simulator to test the response of sedation care providers to sedation emergencies in three different areas of our hospital. The resulting data revealed significant differences in the time it took for different care teams to recognize and rescue patients from apnea and hypoxia, varying from <2 min to more than 6 min (100). In a more widespread application, human simulation is rapidly gaining popularity as a training tool for care providers in anesthesiology and other specialties (98,101,102). The use of this technology to train sedation providers to recognize critical airway emergencies and initiate resuscitation is already in place in several institutions (103). Future work will need to establish the validity of this type of training for pediatric sedation and refine realistic scenarios.
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Future Direction for Pediatric Sedation

Research
In considering the current status of pediatric sedation and the safety issues involved, the future can either be viewed as murky and disturbing or an opportunity to provide clarity through collaborative research and clinical program development. To begin, there is a need to better define the effectiveness and risks associated with the various pediatric sedation protocols that have been proposed in the last several years and will be proposed in the future. As is the case with anesthesia, large clinical trials or databases are required to sort out the frequency of critical events. Information collected from the various institutions and including providers from a multitude of pediatric specialties and practice settings would allow meaningful data analysis on which drugs are being used, how they are delivered, by whom, and with what kinds of outcomes.

Sedation vs. Anesthesia

The proliferation of the use of drug combinations including propofol with potent opiates by nonanesthesiologists in the future will continue to force us to examine the question as to where deep sedation ends and general anesthesia begins. According to the ASA/JCAHO/AAP criteria, the distinguishing characteristic between these two entities is the presence or absence of a response to repeated painful stimuli. Whereas most studies involving sedation do not describe the condition of sedated patients adequately enough to determine the sedation level of the patient, there is no doubt that many of the regimens used in emergency departments and ICUs around the country are evolving into recipes for brief general anesthesia rather than sedation. In light of the fact that the difference between these two states can be subtle (patients can go in and out of a given state quite rapidly) and that there is no practical way to police this practice, any effort to limit anesthesia by nonanesthesiologists for brief procedures in children is doomed to failure.

In terms of promoting safety and generally good sedation delivery, pediatric patients will be better served by advocating for standards anesthesiologists have successfully used to improve the safety of anesthesia care by 10-fold over the last 20 yr (104). Specifically, all providers of deep sedation (that is, everyone who sedates children for painful procedures) should be able to rescue patients from side effects of general anesthesia, as mandated by the JCAHO. To do this, anesthesiologists need to demand that high standards are met by these individuals. These should include, but not be limited to, the following: (a) There should be defined competencies in terms of airway management (i.e., effective bag-mask ventilation), and these skills should be demonstrated in clinical practice or simulation setting; (b) Knowledge of disease entities that impact sedation and anesthesia should be documented; (c) Familiarity with sedation drugs (doses, side effects, and contraindications), reversal drugs, and rescue medications should be documented; (d) Intraprocedural monitoring should mirror those for anesthesia, including optimal methods for monitoring ventilation (capnography) as well as oxygenation; (e) All equipment required for emergency interventions such as masks, airways, suction, and ventilation bags must be present for each sedation, and they must be regularly checked and accounted for; and (f) Sedation systems must have a quality improvement program that examines its own outcomes on a continuing basis.

Reimbursement
The continued improvement of pediatric sedation practice depends on the involvement of qualified professionals. This involvement can only be guaranteed through proper reimbursement. Unfortunately, reimbursement depends on payer mix, private insurer commitment to sedation, and state medicaid reimbursement schedules. As such, there is no blanket answer to the problem of making pediatric sedation an attractive or practical pursuit. To assure reimbursement is appropriate, anesthesiologists need to lobby insurance companies and state agencies to assure that payment is appropriate for this critical service.
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Conclusion
Providing sedation to children is an area of rapid change marked by evolving standards. Whereas anesthesiologists have played a critical role in establishing guidelines for safe sedation, considerable work remains in defining what represents effective and safe practice. The overwhelming demographic demand for pediatric sedation services has mandated that other pediatric specialists and nurses deliver a wide range of sedation outside the operating room. It is critical at this time that anesthesiologists use their established identity as the ultimate experts in this field with a proven track record of practice improvement to assure that clinical practice, training, and safety in this field is optimized.
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Acknowledgments
The authors would like to thank Charles Cot, MD, for his help in compiling this review.

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Footnotes
o

Accepted May 20, 2004.

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