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OBJECTIVE: To revise the "Clinical Practice Guidelines for the Sustained Use of Sedatives and Analgesics in the Critically Ill Adult" published in Critical Care Medicine in 2002. METHODS: The American College of Critical Care Medicine assembled a 20-person, multidisciplinary, multi-institutional task force with expertise in guideline development, pain, agitation and sedation, delirium management, and associated outcomes in adult critically ill patients. The task force, divided into four subcommittees, collaborated over 6 yr in person, via teleconferences, and via electronic communication. Subcommittees were responsible for developing relevant clinical questions, using the Grading of Recommendations Assessment, Development and Evaluation method (http://www.gradeworkinggroup.org) to review, evaluate, and summarize the literature, and to develop clinical statements (descriptive) and recommendations (actionable). With the help of a professional librarian and Refworks database software, they developed a Web-based electronic database of over 19,000 references extracted from eight clinical search engines, related to pain and analgesia, agitation and sedation, delirium, and related clinical outcomes in adult ICU patients. The group also used psychometric analyses to evaluate and compare pain, agitation/sedation, and delirium assessment tools. All task force members were allowed to review the literature supporting each statement and recommendation and provided feedback to the subcommittees. Group consensus was achieved for all statements and recommendations using the nominal group technique and the modified Delphi method, with anonymous voting by all task force members using E-Survey (http://www.esurvey.com). All voting was completed in December 2010. Relevant studies published after this date and prior to publication of these guidelines were referenced in the text. The quality of evidence for each statement and recommendation was ranked as high (A), moderate (B), or low/very low (C). The strength of recommendations was ranked as strong (1) or weak (2), and either in favor of (+) or against (-) an intervention. A strong recommendation (either for or against) indicated that the intervention's desirable effects either clearly outweighed its undesirable effects (risks, burdens, and costs) or it did not. For all strong recommendations, the phrase "We recommend …" is used throughout. A weak recommendation, either for or against an intervention, indicated that the trade-off between desirable and undesirable effects was less clear. For all weak recommendations, the phrase "We suggest …" is used throughout. In the absence of sufficient evidence, or when group consensus could not be achieved, no recommendation (0) was made. Consensus based on expert opinion was not used as a substitute for a lack of evidence. A consistent method for addressing potential conflict of interest was followed if task force members were coauthors of related research. The development of this guideline was independent of any industry funding. CONCLUSION: These guidelines provide a roadmap for developing integrated, evidence-based, and patient-centered protocols for preventing and treating pain, agitation, and delirium in critically ill patients.

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OBJECTIVE: To validate the Sedation-Agitation Scale (SAS) with the Visual Analog Scale (VAS) and Bispectral Index (BIS) in adult ICU patients after cardiac surgery. DESIGN: Prospective study comparing blinded evaluations of the SAS, VAS and BIS. SETTING: Forty-two-bed multidisciplinary ICU. PATIENTS AND PARTICIPANTS: Convenience sample of 39 adults after cardiac surgery. MEASUREMENTS AND RESULTS: Bispectral Index 3.2 was continuously recorded using the Aspect A-1000 and evaluators were blinded to this value. The bedside nurse and a trained researcher independently rated wakefulness using a 100 mm VAS upon patient arrival on the ICU, at first awakening, when ventilator weaning was started and after extubation; the researcher also evaluated patients using SAS. Upon arrival on the ICU, the median SAS score was 2 (interquartile range = 1-3), the mean VAS was 26+/-30 and the mean BIS was 70+/-16. Twenty-four patients underwent a trial of weaning from mechanical ventilation with a SAS of 4 (IQR = 4), VAS of 86+/-12 and BIS of 87+/-10. SAS correlated well with VAS performed by one researcher (r = 0.91, p < 0.001) or by 19 different bedside nurses (r = 0.43, p < 0.001) and with BIS 3.2 (r = 0.60, p < 0.001). The correlation between SAS and BIS was reduced in patients with above average electromyogram (EMG) power. As a measure of construct validity, significant differences were noted for the BIS, SAS, VAS and EMG between ICU arrival and extubation (all p < 0.001). CONCLUSIONS: Sedation-Agitation Scale and BIS are valid measures of wakefulness after cardiac surgery, but EMG interference may affect the accuracy of BIS for a small percentage of patients not receiving neuromuscular blockade.

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STUDY OBJECTIVES: To determine the validity and reliability of the Sedation-Agitation scale (SAS) when administered by intensive care unit (ICU) nurses with no experience in its use. DESIGN: Prospective, psychometric evaluation. SETTING: Adult medical-cardiac ICU. PATIENTS: Sixty patients. INTERVENTION: Sedation and agitation were observed simultaneously but independently by nurses and two investigators, and patients were rated with the SAS. The assessment of an experienced clinical nurse specialist was recorded on visual analog scales (VAS) for sedation (VAS-S) and agitation (VAS-A). MEASUREMENTS AND MAIN RESULTS: The SAS scores of ICU staff nurses were compared with VAS scored by the clinical nurse specialist using Pearson correlation coefficient. The SAS correlated well with VAS-S (Spearman's p = -0.77, p<0.001). Neither SAS nor VAS-A was correlated (Spearman's p = 0.05, p>0.5), but there were few observations of agitated patients. The SAS interrater agreement was excellent between the two trained investigators (weighted K = 0.93, p<0.001) and between investigators and staff nurses (weighted K = 0.85 and 0.87, p<0.001 for both). CONCLUSION: The SAS is reliable when administered by staff nurses with no experience with it. Due to the paucity of observations of agitated patients, we were unable to determine its validity for assessing agitation.

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OBJECTIVE: To determine the frequency and pattern with which patients in the intensive care unit (ICU) remove medical devices on their own, and the costs associated with this problem. DESIGN: Prospective observational study. SETTING: Two 10-bed sections of a multidisciplinary ICU in a tertiary care teaching hospital. PATIENTS: Adults admitted to the ICU for longer than 24 hours during October 1998. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Medical records were reviewed prospectively for the occurrence of patient-initiated device removal and the responses to those events by health care providers. Associated costs were estimated using hospital databases and Medicare physician reimbursement schedules. Annual cost estimates were calculated using 1997 admission statistics for 1211 adults in an ICU for more than 24 hours. Thirty-six patients were studied for 199 patient-days. Ten patients (28%) removed 42 devices: 88% of these events involved gastrointestinal tubes and vascular catheters. Significant agitation was documented within 2 hours before 74% of the events. Estimated cost associated with device removal was $7606, or $181/event. The estimated annual cost in this 42-bed ICU was more than $250,000. CONCLUSIONS: Patients commonly remove medical devices on their own, and this represents significant consumption of health care resources.

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OBJECTIVE: To assess adrenocortical function following intravenous etomidate use in emergency department (ED) patients requiring intubation. METHODS: This was a prospective, randomized, controlled trial of consecutive patients presenting to the ED requiring intubation. Patients were randomized to receive a single bolus induction dose of either 0.05-0.1 mg/kg midazolam (control group) or 0.3 mg/kg etomidate (etomidate group) during a standardized rapid-sequence intubation (RSI) with succinylcholine. The primary outcome variable was adrenocortical function at 4, 12, and 24 hours post-induction as assessed by measured serum cortisol response to exogenous cosyntropin (cosyntropin stimulation test, CST). Fisher's exact test was used to compare CST results between groups. RESULTS: Thirty-one patients were enrolled: 8 control, 10 etomidate, and 13 excluded from analysis for either incomplete data or steroid use during the study period. The 4-hour CST results were significantly different between study groups, with a normal response in 100% of control patients vs 30% of etomidate patients (p = 0.004). The 12- and 24-hour CSTs did not differ significantly between groups: normal CST in 100% of control patients at 12 and 24 hours vs 100% and 90% among etomidate patients at 12 and 24 hours, respectively (p = 1.0 at 12 and 24 hours). Measured cortisol levels of patients with abnormal CSTs remained within normal laboratory reference ranges. CONCLUSION: Use of etomidate in ED patients requiring RSI results in adrenocortical dysfunction. However, cortisol levels remain within normal laboratory levels during this period of dysfunction. Adrenocortical dysfunction appears to resolve within 12 hours of a single bolus dose of 0.3 mg/kg etomidate.

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OBJECTIVE: To review methods for assessing sedation in critically ill adults, discuss their impact on patient outcomes, and provide recommendations for implementing these methods into clinical practice in the intensive care unit (ICU). DATA SOURCES: A computerized search of MEDLINE from 1980 through June 2000 and a manual search of abstracts presented at recent critical care meetings were performed. STUDY SELECTION AND DATA EXTRACTION: Sedation assessment tools that have been used to titrate therapy in adult, critically ill patients were identified. Special emphasis was placed on sedation assessment instruments that have been prospectively validated. Objective methods that have been used to assess sedation therapy were also identified. DATA SYNTHESIS: Twenty-three adult sedation assessment instruments were identified. Few scales have been prospectively evaluated for validity (n = 6) or reliability (n = 7). Other methods of sedation assessment were identified (e.g., bispectral index monitor); however, most of these methods have only been studied in small subsets of critically ill patients. CONCLUSIONS: Incorporation of sedation assessment into ICU clinical practice may improve patient care. These sedation assessment instruments must be further evaluated to determine their impact on quality of care and ICU length of stay.

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The recent development of valid and reliable assessment tools to monitor agitation, sedation, analgesia, and delirium in the ICU represents an essential first step in the provision of patient comfort and the development of preferred treatment strategies. To make the ICU a more humane healing environment, these assessment tools must be used as part of a comprehensive evaluation of interventional and preventive treatments, pharmacologic and nonpharmacologic. In the spirit of the JCAHO, it may be time to add the evaluation of sedation, agitation, and delirium to that of pain assessment, making all aspects of patient comfort the fifth vital sign for the critically ill.

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Preliminary evidence suggests that closely monitoring sedation may have a positive effect on patient outcomes, including reductions in intensive care unit (ICU) stay, duration of mechanical ventilatory support, and number of diagnostic tests requested to assess central nervous system function. In the last few years, subjective instruments to assess agitation and sedation have been developed and tested for reliability and validity, including the Sedation-Agitation Scale and the Motor Activity Assessment Scale. Similar efforts directed to delirium among ICU patients have produced several assessment tools to help clinicians with this difficult area of patient care. Promising techniques for objective assessment of sedation (such as the bispectral index) and strategies to guide neuromuscular blockade with train-of-four (TOF) or clinical exam monitoring have emerged. Future efforts should focus on evaluating the impact of these monitoring techniques on specific outcomes in an effort to improve patient comfort, minimize adverse events, and reduce resource consumption.

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STUDY OBJECTIVE: To study the frequency, duration, severity, and treatment of agitation in patients in the intensive care unit (ICU) to determine if the elderly represent a distinct population. DESIGN: Prospective cohort study SETTING: Tertiary care, 10-bed, multidisciplinary ICU. PATIENTS: All patients older than 18 years of age admitted for longer than 24 hours during a 4-month period. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: One hundred thirty patients were studied for 916 patient-days; 63 (48%) were elderly (> 65 yrs). Nurses and physicians described agitated behavior in 92 patients (70.8%) during 534 (58.3%) patient-days, and it was severe or dangerous in 60 patients (46.1%) during 273 (30%) patient-days. There were no age-related differences in frequency, severity, and duration of agitation. Opiates, benzodiazepines, and haloperidol were administered during 72%, 62%, and 29% of agitated patient-days, respectively. Haloperidol was administered more often to elderly patients (p=0.015); otherwise no between-group differences were noted. Daily dosing requirements were less in the elderly for intermittent intravenous lorazepam, haloperidol, and morphine but not for midazolam (p=0.15). When these dosages were corrected for body mass, no statistical differences between young and old were found. CONCLUSION: In the ICU, the elderly are not a distinct population for agitation.

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OBJECTIVE: To describe the level of sedation for a cohort of mechanically ventilated adult intensive care unit (ICU) patients using validated subjective and objective tools. DESIGN: Prospective convenience sample. SETTING: Multidisciplinary 34-bed ICU at Maine Medical Center, a 599-bed nonuniversity, academic medical center. PATIENTS: Sixty-three adult ICU patients were monitored during 64 episodes of ventilatory support. MEASUREMENTS AND MAIN RESULTS: Patients were prospectively evaluated by one trained investigator using the revised Sedation-Agitation Scale (SAS) and were simultaneously monitored for 1 to 5 hrs using the Bispectral Index (BIS), a numeric scale from 0 to 100 derived from the electroencephalogram. BIS values were assigned to baseline, stimulated, and average conditions for each patient by a separate investigator blinded to SAS scores. Ventilator settings, medications, and the lung injury severity (LIS) score were also recorded. Sedation levels varied from very deep sedation (SAS score = 1, BIS score = 43) to mild agitation (SAS score = 5, BIS score = 100). Heavily sedated patients (SAS score = 1-2, n = 20) had higher FIO2 (0.52 vs. 0.42, p = .008), oxygenation index (9.4 vs. 5.4, p = .03), and LIS scores (1.3 vs. 0.7, p = .004) and lower baseline (66 vs. 78, p = .01), average (66 vs. 81, p < .001), and stimulated (89 vs. 96, p = .016) BIS scores compared with more awake patients. Patients with intermittent neuromuscular blockade use (n = 4) had higher FIO2 (0.65 vs. 0.44, p = .006), minute ventilation (14.6 vs. 9.9 L/min, p = .005), positive end-expiratory pressure (7.5 vs. 4.8 cm H2O, p = .05), oxygenation index (15.7 vs. 6.0, p < .001), and LIS scores (3.3 vs. 1.0, p = .036) and were more sedated, with higher suppression ratios (3.5 vs. 0.6, p = .05) and lower SAS scores (1.5 vs. 4, p = .035). The average BIS values correlated well with SAS (r2 = .21, p < .001). CONCLUSIONS: SAS and BIS work well to describe the depth of sedation for ventilated ICU patients. Deeper sedation and intermittent neuromuscular blockade were used for patients with greater ventilatory requirements and more severe lung disease. The correlation between subjective and objective scales varied in medical, surgical, and trauma patients. Further research with SAS and BIS may facilitate the development of quantitative sedation guidelines for the ICU.

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OBJECTIVE: Subjective scales to assess agitation and sedation in adult intensive care unit (ICU) patients have rarely been tested for validity or reliability. We revised and prospectively tested the Sedation-Agitation Scale (SAS) for interrater reliability and compared it with the Ramsay scale and the Harris scale to test construct validity. DESIGN: A convenience sample of ICU patients was simultaneously and independently examined by pairs of trained evaluators by using the revised SAS, Ramsay, and Harris Scales. SETTING: Multidisciplinary 34-bed ICU in a nonuniversity, academic medical center. PATIENTS: Forty-five ICU patients (surgical and medical) were examined a total of 69 times by evaluator pairs. MEASUREMENTS AND MAIN RESULTS: The mean patient age was 63.2 yrs, 36% were female, and 71% were intubated. When classified by using SAS, 45% were anxious or agitated (SAS 5 to 7), 26% were calm (SAS 4), and 29% were sedated (SAS 1 to 3). Interrater correlation was high for SAS (r2 = .83; p < .001) and the weighted kappa score for interrater agreement was 0.92 (p < .001). Of 41 assessments scored as Ramsay 1, 49% scored SAS 6, 41% were SAS 5, 5% were SAS 4, and 2% each were SAS 3 or 7. SAS was highly correlated with the Ramsay (r2 = .83; p < .001) and Harris (r2 = .86; p < .001) scales. CONCLUSIONS: SAS is both reliable (high interrater agreement) and valid (high correlation with the Harris and Ramsay scales) in assessing agitation and sedation in adult ICU patients. SAS provides additional information by stratifying agitation into three categories (compared with one for the Ramsay scale) without sacrificing validity or reliability.

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The pyridinium metabolites formed in the MAO-B catalyzed oxidation of 1-methyl-4-substituted-1,2,3,6-tetrahydropyridinyl derivatives, such as the parkinsonian inducing agent 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP), cause the selective degeneration of nigrostriatal neurons, presumably by inhibition of mitochondrial respiration and depletion of ATP stores. The possibility that other partially oxidized piperidinyl derivatives also may be biotransformed to toxic pyridinium metabolites has led us to examine the metabolic fate of the neuroleptic agent haloperidol (HP) and its tetrahydropyridinyl dehydration product 4-(4-chlorophenyl)-1[4-(4-fluorophenyl)-4-oxobutyl]- 1,2,3,6-tetrahydropyridine (HPTP). In vitro metabolic studies employing tissue preparations isolated from rodents, baboons and humans have documented that cytochrome P4503A enzymes catalyze the biotransformation of both HP and HPTP to yield the corresponding pyridinium metabolite HPP+. An analogous biotransformation profile has been observed with "reduced haloperidol" (RHP), an abundant, circulating metabolite of HP formed by the stereospecific reduction of the benzoyl carbonyl group of HP. In vivo studies also have documented these pathways in humans, baboons and rodents. Although both HPP+ and RHPP+ are found in the urine and plasma of HP treated patients and HP or HPTP treated baboons, attempts to identify an MPTP-type lesion in baboons following long-term treatment with HPTP have failed. On the other hand, evidence for a lesion of the nucleus basalis of Meynert has been obtained. Additionally, the urinary excretion of abnormal organic acids and acylcarnitine conjugates suggests that HP and/or metabolites derived from HP interfere with energy production pathways.

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Intravenous haloperidol is recommended as the drug of choice to treat delirium in ICU patients. Movement disorders and other adverse events commonly occur with oral haloperidol use but are rarely seen with IV haloperidol use, and withdrawal symptoms have not been reported with short-term ICU use. We describe self-limited dyskinesia during withdrawal of high-dose continuous IV haloperidol therapy in five ICU patients.

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The metabolism of haloperidol (HP) to the potentially neurotoxic pyridinium species, HPP+ and RHPP+, has been demonstrated in humans. In vitro studies in microsomes harvested from various animal species indicate that the tetrahydropyridines, HPTP and RHPTP, could be intermediates in this pathway. However, this has not yet been demonstrated in vivo in humans. In this study, plasma and urine collected from eight critically ill patients treated with high doses of intravenous HP were analyzed for HPTP and RHPTP using HPLC with electrochemical detection. However, neither HPTP nor RHPTP were detected despite plasma concentrations of HP and RHP higher than any previously reported. HPP+ and RHPP+ were both present in the urine in high concentrations and accounted for 1.1 +/- 0.5% and 5.3 +/- 3.6%, respectively, of the administered dose of HP. The apparent elimination half-lives of HPP+ and RHPP+ were 67.3 +/- 11.0 hr and 63.3 +/- 11.6 hr, respectively. The absence of HPTP and RHPTP in plasma and urine suggests that in humans these tetrahydropyridines either are insignificant intermediates in the metabolism of HP in vivo or are present only transiently at their site of formation and are not released into the circulation.

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Our objective was to evaluate physician response to an educational program to increase referral of potential organ or tissue donors in an emergency department (ED). This study was a nonrandomized, controlled, before-after intervention trial at a nonuniversity teaching hospital with 45,000 annual patient visits to the ED. Two one-hour educational sessions reviewed with EMP (but not CON) the physician's role in requesting donation, donor criteria, required-request legislation, and services available from organ procurement professionals. Rates of consideration for donation, discussion with family, consent for donation, recovery of tissues or organs for donation and completion of a donor request form were evaluated before and after the intervention by a blinded chart reviewer. Prior to the intervention, tissue recovery was 0% of EMP and 4% for CON. After intervention, the EMP rate increased to 48% (p < 0.001) but CON remained unchanged (5%, p = 1.0). Similar increases limited to the EMP group were seen for mentioning donation in the narrative chart (1% to 68%, p < 0.001), discussion with family (1% to 65%, p < 0.001), and consent for donation (0% to 32%, p < 0.001). The effect of the intervention was not sustained, with decreased rates of mentioning donation (p = 0.004) and discussion with family (p = 0.02) over six months. Physician education increases request for donation, consent for donation, and recovery of tissue. The duration of this effect is short-lived; repeated interventions may be necessary.

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OBJECTIVE: To evaluate the safety and efficacy of continuous infusion of haloperidol in treating agitated critically ill adult patients. DESIGN: Case series of patients treated with continuous infusion of haloperidol and followed to hospital discharge, during a 6-month period. SETTING: A 34-bed multidisciplinary intensive care unit (ICU) in a 598-bed nonuniversity, tertiary care teaching hospital. PATIENTS: Consecutive sample of eight patients requiring mechanical ventilation who had severe agitation which was refractory to intermittent bolus treatment with benzodiazepines, narcotics, and haloperidol. INTERVENTIONS: Continuous infusions of haloperidol (range 3 to 25 mg/hr) were supplemented, as required, to maintain adequate sedation. MEASUREMENTS AND MAIN RESULTS: The four men and four women averaged 47 yrs of age, and the average length of hospitalization was 33 days, with 25 days spent in the ICU. On the day continuous infusion of haloperidol was initiated, the average Acute Physiology and Chronic Health Evaluation (APACHE) II and Therapeutic Intervention Scoring System (TISS) scores were 24 and 47, respectively. The Sedation-Agitation Scale score averaged +2.4 (maximum agitation score being +3) before continuous infusion of haloperidol decreasing to +1.8 after 1 day (p = .38) and to +0.8 after 2 days (p = .06) of continuous infusion of haloperidol. The average daily haloperidol dose increased from 68 mg before continuous infusion of haloperidol to 269 mg (p < .008) after 1 day. The daily total of nonhaloperidol sedatives decreased from 18.3 to 10.9 sedation-equivalent units (p = .15) and the daily number of bolus administrations of sedatives decreased from 23 to 7 (p = .01) after 1 day of continuous infusion of haloperidol. Estimated nursing time to prepare, administer, and monitor these bolus medications decreased from 320 to 96 mins per 24 hrs (p = .01). Of the five patients discharged alive (37.5% mortality rate), four were successfully weaned from assisted ventilation during continuous infusion of haloperidol. Two of these four patients were difficult to wean because of agitation and oversedation. Four possible complications were noted: minor tremors (n = 2), atrial dysrhythmias with intermittent third-degree atrioventricular block and QT interval prolongation (n = 1), and ventricular tachycardia (n = 1). CONCLUSIONS: Continuous infusion of haloperidol effectively controls severe agitation in critically ill patients, reduces requirements for bolus administration of sedatives and nursing time lost to that task, and may facilitate ventilator weaning. Parenteral administration of haloperidol was associated with few complications in > 1,340 patient-hours of continuous administration.

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