A Prospective Study of Intramuscular Droperidol or Olanzapine for Acute Agitation in the Emergency Department: A Natural Experiment Owing to Drug Shortages.

STUDY OBJECTIVE: Intramuscular medications are commonly used to treat agitation in the emergency department (ED). The purpose of this study is to compare intramuscular droperidol and olanzapine for treating agitation. METHODS: This was a prospective observational study of ED patients receiving intramuscular droperidol or olanzapine for acute agitation. The treating physician determined the medication and dose; however, over time drug shortages made either olanzapine (July to September 2019) or droperidol (November 2019 to March 2020) unavailable, creating a natural experiment. The primary outcome was time to adequate sedation, assessed by the Altered Mental Status Scale (AMSS), defined as time to AMSS score less than or equal to 0. RESULTS: We analyzed 1,257 patients (median age 42 years; 73% men); 538 received droperidol (median dose 5 mg) and 719 received olanzapine (median dose 10 mg). The majority of patients (1,086; 86%) had agitation owing to alcohol intoxication. Time to adequate sedation was 16 minutes (interquartile range 10 to 30 minutes) for droperidol and 17.5 minutes (interquartile range 10 to 30 minutes) for olanzapine (absolute difference -0.7 minutes; 95% confidence interval -2.1 to 0.5 minutes). Adjusted Cox proportional hazard model analysis revealed no difference between groups in time to sedation (hazard ratio for adequate sedation for droperidol compared with olanzapine 1.12; 95% confidence interval 1.00 to 1.25). Patients receiving olanzapine were more likely to receive additional medications for sedation (droperidol 17%; olanzapine 24%; absolute difference -8% [95% confidence interval -12% to -3%]). We observed no difference between drugs regarding adverse effects except for extrapyramidal adverse effects, which were more common with droperidol (n=6; 1%) than olanzapine (n=1; 0.1%). CONCLUSION: We found no difference in time to adequate sedation between intramuscular droperidol and olanzapine.

Rapid Sequence Airway with the Intubating Laryngeal Mask in the Emergency Department.

BACKGROUND: The administration of sedation and neuromuscular blockade to facilitate extraglottic device (EGD) placement is known as rapid sequence airway (RSA). In the emergency department (ED), EGDs are used largely as rescue devices. In select patients, there may be significant advantages to using EGDs over laryngoscopy as the primary airway device in the ED. OBJECTIVE: Our study sought to describe the practice of RSA in the ED, including rates of successful oxygenation, ventilation, and complications from EGD use. METHODS: We identified patients in the ED between 2007 and 2017 who underwent RSA with the LMA® Fastrach™ (hereafter termed ILMA; Teleflex Medical Europe Ltd., Athlone, Ireland) placed as the first definitive airway management device. A trained abstractor performed chart and video review of the cases to determine patient characteristics, physician use of the ILMA, indication for ILMA placement, success of oxygenation and ventilation, success of intubation, and complications related to the device. RESULTS: During the study period, 94 patients underwent RSA with the ILMA. Of those, 93 (99%) were successfully oxygenated and ventilated, and when intubation was attempted, 89% were able to be intubated through the ILMA. The incidence of vomiting and aspiration was 1% and 3%, respectively. There were 30 different attending physicians who supervised RSA and the median number was 2 per physician in the 10-year study period. CONCLUSION: The practice of RSA with the ILMA in the ED is associated with a high rate of successful oxygenation, ventilation, and intubation with infrequent complications, even when performed by physicians with few experiences in the approach.

Feasibility and initial experience with continuous nerve blocks by emergency physicians.

INTRODUCTION: Peripheral nerve blocks and regional anesthesia are routinely used to alleviate pain in the emergency department. Our objective is to report on the feasibility and initial experience of emergency physicians initiating and managing continuous nerve blocks for trauma patients. METHODS: This was a retrospective, observational cohort study of a convenience sample of patients 18 years or older presenting with either rib or hip fractures between August 15, 2016 and January 15, 2019. Demographic and clinical data was abstracted using a structured data collection form. Data collected included basic demographics, mechanism of injury, type of regional anesthesia, admission location, respiratory complications, pre- and post-procedure opioid use, efficacy of anesthesia and duration of continuous nerve blockade. All analyses were descriptive in nature, including means, median, and range when appropriate. RESULTS: Forty-one patients presented during the study period with rib or hip fractures and received a nerve block catheter and a continuous infusion pump. The mean age of patients was 65.9 years and 26 (63.4%) patients were male. The mean duration of continuous nerve blockade was 3.4 days (range 1-9 days). Hourly opioid use was reduced by 58%. The most common complication was accidental dislodgement of the catheter;, no patient developed a pneumothorax, hemothorax, catheter related infection, or hematoma. CONCLUSIONS: It is feasible and effective for emergency physicians to initiate and manage continuous nerve blockade for acute hip and rib fractures. Continuous nerve blockade may allow trauma patients to significantly decrease their use of opioids.

The Use, Safety, and Efficacy of Olanzapine in a Level I Pediatric Trauma Center Emergency Department Over a 10-Year Period.

OBJECTIVES: Olanzapine is a second-generation antipsychotic increasingly used in emergency medicine for many indications. Literature on its use in children is sparse. Our objectives were to describe the use, safety, and efficacy of olanzapine in pediatric emergency patients. METHODS: A structured chart review was performed of patients 18 years old or younger receiving olanzapine from 2007 to 2016 in the emergency department of a pediatric level I trauma center. RESULTS: A total of 285 children received olanzapine. Mean age was 16.4 years (range, 9-18 years); 121 were male (42.8%). Primary indications for olanzapine included agitation (n = 166, 58.3%), headache (n = 58, 20.4%), nausea/vomiting/abdominal pain (n = 37, 12.5%), unspecified pain (n = 20, 7%), and other (n = 4, 1.4%). Route of olanzapine administration was intramuscular (n = 160, 56%; median dose, 10 mg; range, 2.5-20), intravenous (n = 101, 36%; median dose, 5 mg; range, 1.25-5), and oral (n = 24, 8%; median dose, 10 mg; range, 5-10). For agitated patients, 28 (17%) received another sedative within 1 hour. For headache patients, 5 (8.6%) received another analgesic. For gastrointestinal complaints, 5 patients (13.5%) received another analgesic/antiemetic. Adverse respiratory events were hypoxia (pulse oximetry reading, in percentage, <92%; n = 7, 2.4%), supplemental oxygen placement (n = 9, 3.2%), and intubation (n = 2, 0.7%). No patient died or had a dysrhythmia. One patient experienced dystonia. CONCLUSIONS: Olanzapine seems safe when used for a variety of conditions in pediatric emergency patients. It may be effective for acute agitation, primary headache, and gastrointestinal complaints.

Rescue Sedation When Treating Acute Agitation in the Emergency Department With Intramuscular Antipsychotics.

BACKGROUND: Rapid treatment of agitation in the emergency department (ED) is critical to avoid injury to patients and providers. Treatment with intramuscular antipsychotics is often utilized, but there is a paucity of comparative effectiveness evidence available. OBJECTIVE: The purpose of this investigation was to compare the effectiveness of droperidol, olanzapine, and haloperidol for treating agitation in the ED. METHODS: This was a retrospective observational study of adult patients who received intramuscular medication to treat agitation. Patients were classified based on the initial antipsychotic they received. The primary effectiveness outcome was the rate of additional sedation administered (rescue medication) within 1 h. Secondary outcomes included rescue sedation for the entire encounter and adverse events. RESULTS: There were 15,918 patients included (median age 37 years, 75% male). Rescue rates at 1 h were: 547/4947 for droperidol (11%, 95% confidence interval [CI] 10-12%), 988/8825 olanzapine (11%, 95% CI 10-12%), and 390/2146 for haloperidol (18%, 95% CI 17-20%). Rescue rates for the entire ED encounter were: 832/4947 for droperidol (17%, 95% CI 16-18%), 1665/8825 for olanzapine (19%, 95% CI 18-20%), and 560/2146 for haloperidol (26%, 95% CI 24-28%). Adverse events were uncommon: intubation (49, 0.3%), akathisia (7, 0.04%), dystonia (5, 0.03%), respiratory arrest (1, 0.006%), and torsades de pointes (0), with no significant differences between drugs. CONCLUSIONS: Olanzapine and droperidol lead to lower rates of rescue sedation at 1 h and overall, compared with haloperidol. There were no significant differences in major adverse events.

Unsuspected Critical Illness Among Emergency Department Patients Presenting for Acute Alcohol Intoxication.

STUDY OBJECTIVE: Emergency department (ED) visits for acute alcohol intoxication are common, but this population is at risk for decompensation and occult critical illness. The purpose of this study is to describe the incidence and predictors of unsuspected critical illness among patients with acute alcohol intoxication. METHODS: This was a retrospective observational study of ED patients from 2011 to 2016 with acute alcohol intoxication. The study cohort included patients presenting for alcohol intoxication, whose initial assessment was uncomplicated alcohol intoxication without any other active acute medical or traumatic complaints. The primary outcome was defined as the unanticipated subsequent use of critical care resources during the encounter or admission to an ICU. We investigated potential predictors for this outcome with generalized estimating equations. RESULTS: We identified 31,364 eligible patient encounters (median age 38 years; 71% men; median breath alcohol concentration 234 mg/dL); 325 encounters (1%) used critical care resources. The most common diagnoses per 1,000 ED encounters were acute hypoxic respiratory failure (3.1), alcohol withdrawal (1.7), sepsis or infection (1.1), and intracranial hemorrhage (1.0). Three patients sustained a cardiac arrest. Presence of the following had an increased adjusted odds ratio (aOR) of developing critical illness: hypoglycemia (aOR 9.2), hypotension (aOR 3.8), tachycardia (aOR 1.8), fever (aOR 7.6), hypoxia (aOR 3.8), hypothermia (aOR 4.2), and parenteral sedation (aOR 2.4). The initial blood alcohol concentration aOR was 1.0. CONCLUSION: Critical care resources were used for 1% of ED patients with alcohol intoxication who were initially assessed by physicians to have low risk. Abnormal vital signs, hypoglycemia, and chemical sedation were associated with increased odds of critical illness.

Intramuscular Midazolam, Olanzapine, Ziprasidone, or Haloperidol for Treating Acute Agitation in the Emergency Department.

STUDY OBJECTIVE: Agitation in the emergency department (ED) can pose a threat to patient and provider safety; therefore, treatment is indicated. The purpose of this study is to compare haloperidol, olanzapine, midazolam, and ziprasidone to treat agitation. METHODS: This was a prospective observational study of consecutive patients receiving intramuscular medication to treat agitation in the ED. Medications were administered according to an a priori protocol in which the initial medication given was predetermined in the following 3-week blocks: haloperidol 5 mg, ziprasidone 20 mg, olanzapine 10 mg, midazolam 5 mg, and haloperidol 10 mg. The primary outcome was the proportion of patients adequately sedated at 15 minutes, assessed with the Altered Mental Status Scale. RESULTS: Seven hundred thirty-seven patients were enrolled (median age 40 years; 72% men). At 15 minutes, midazolam resulted in a greater proportion of patients adequately sedated (Altered Mental Status Scale <1) compared with ziprasidone (difference 18%; 95% confidence interval [CI] 6% to 29%), haloperidol 5 mg (difference 30%; 95% CI 19% to 41%), haloperidol 10 mg (difference 28%; 95% CI 17% to 39%), and olanzapine (difference 9%; 95% CI -1% to 20%). Olanzapine resulted in a greater proportion of patients adequately sedated at 15 minutes compared with haloperidol 5 mg (difference 20%; 95% CI 10% to 31%), haloperidol 10 mg (difference 18%; 95% CI 7% to 29%), and ziprasidone (difference 8%; 95% CI -3% to 19%). Adverse events were uncommon: cardiac arrest (0), extrapyramidal adverse effects (2; 0.3%), hypotension (5; 0.5%), hypoxemia (10; 1%), and intubation (4; 0.5%), and occurred at similar rates in each group. CONCLUSION: Intramuscular midazolam achieved more effective sedation in agitated ED patients at 15 minutes than haloperidol, ziprasidone, and perhaps olanzapine. Olanzapine provided more effective sedation than haloperidol. No differences in adverse events were identified.

Etiologies of altered mental status in patients with presumed ethanol intoxication.

BACKGROUND: Altered mental status is a commonly evaluated problem in the ED. Ethanol intoxication is common, and prehospital history may bias emergency physicians to suspect this as the cause of altered mental status. Quantitative ethanol measurement can rapidly confirm the diagnosis, or if negative, prompt further evaluation. Our objective was to identify the etiologies of altered mental status in ED patients initially presumed to be intoxicated with ethanol but found to have negative quantitative ethanol levels. METHODS: This was a 5-year (2012-2016) electronic medical record review of ED patients presenting with altered mental status. Patients were included if they presented with presumed ethanol intoxication and had an initial ethanol concentration of zero. Etiologies of altered mental status were categorized into medical, traumatic, psychiatric, and drug-related causes. RESULTS: 29,322 patients presented during the study period with presumed alcohol intoxication, 1875 patients had negative ethanol levels. The etiology of altered mental status was due to illicit substances in 1337 patients (71%), psychiatric causes in 354 patients (19%), medical causes in 166 patients (9%) and trauma in 18 patients (1%). A total of 179 patients (10%) were admitted to the hospital; 19 patients (1%) to the ICU. CONCLUSIONS: The presumptive diagnosis of ethanol intoxication in patients presenting to the ED with altered mental status was inaccurate in 5% of patients. The etiology of altered mental status was serious and required hospitalization in 10% of the cohort. Rapid assessment of quantitative ethanol levels should be performed, breathalyzers may be preferred over serum testing.

Emergency department length of stay for ethanol intoxication encounters.

BACKGROUND: Emergency Department (ED) encounters for ethanol intoxication are becoming increasingly common. The purpose of this study was to explore factors associated with ED length of stay (LOS) for ethanol intoxication encounters. METHODS: This was a multi-center, retrospective, observational study of patients presenting to the ED for ethanol intoxication. Data were abstracted from the electronic medical record. To explore factors associated with ED LOS, we created a mixed-effects generalized linear model. RESULTS: We identified 18,664 eligible patients from 6 different EDs during the study period (2012-2016). The median age was 37years, 69% were male, and the median ethanol concentration was 213mg/dL. Median LOS was 348min (range 43-1658). Using a mixed-effects generalized linear model, independent variables associated with a significant increase in ED LOS included use of parenteral sedation (beta=0.30, increase in LOS=34%), laboratory testing (beta=0.21, increase in LOS=23%), as well as the hour of arrival to the ED, such that patients arriving to the ED during evening hours (between 18:00 and midnight) had up to an 86% increase in LOS. Variables not significantly associated with an increase in LOS included age, gender, ethanol concentration, psychiatric disposition, using the ED frequently for ethanol intoxication, CT use, and daily ED volume. CONCLUSION: Variables such as diagnostic testing, treatments, and hour of arrival may influence ED LOS in patients with acute ethanol intoxication. Identification and further exploration of these factors may assist in developing hospital and community based improvements to modify LOS in this population.

A brief assessment of capacity to consent instrument in acutely intoxicated emergency department patients.

OBJECTIVE: The aim of this study was to determine to what extent acute alcohol intoxication effects capacity to assent, consent, or refuse research participation. METHODS: This was a prospective, observation study performed at our inner city, county hospital with >100,000 annual emergency department visits. Non-pregnant, English speaking patients older than 18 with evidence of acute alcohol intoxication were considered eligible. After medical screening, a trained research associate presented the study version of the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) tool. The primary outcome was the number of patients able to correctly respond to all 10 questions. RESULTS: Of 642 screened patients, 415 patients were enrolled and completed the tool. The mean alcohol concentration was 227mg/dL (range 25-500mg/dL). Sixteen patients (3.9%) answered all 10 questions correctly; by definition of the UBACC, these patients were deemed to possess capacity to consent. Mean alcohol concentrations in the capacity group were lower than in those lacking capacity; 182mg/dL (SD 6.7) versus 229mg/dL, (SD 7.9). Of the 287 patients who were interviewed upon sobriety at discharge, 182 patients (63.4%) did not recall completing the questionnaire. CONCLUSIONS: While intoxicated emergency department patients are able to complete the questionnaire, the majority do not possess capacity to provide informed consent to research. A minority of participants remember involvement once they have achieved sobriety, exception from informed consent protocols are needed to perform emergency research in this population.

Developing a Medical Scribe Program at an Academic Hospital: The Hennepin County Medical Center Experience.

BACKGROUND: Medical scribes are frequently incorporated into the patient care model to improve provider efficiency and enable providers to refocus their attention to the patient rather than the electronic health record (EHR). The medical scribe program was based on four pillars (objectives): (1) provider satisfaction, (2) standardized documentation, (3) documentation components for risk adjustment, and (4) revenue enhancement. METHODS: The medical scribe program was deployed in nine non-resident-supported clinics (internal medicine, ophthalmology, orthopedics, hematology/oncology, urology), with the medical scribes (who have no clinical duties) supporting both physicians and advanced practice providers (nurse practitioners and physician assistants). This paper describes a prospective quasi-experimental study conducted at an academic, inner-city, hospital-based clinic system, RESULTS: A pre-post analysis showed positive results; of the 51 providers, 44 responded to the survey pre and 41 responded post. Respondents in the post-scribe group felt that a scribe was valuable (90.2%), that documentation time at the office improved (75.0% poor or marginal pre-scribe, vs. 24% post; p <0.0001), and that time spent on the EHR at home declined (63.6% with excessive or moderately high home EHR time pre vs. 31.7% post; p = 0.003). More providers felt satisfied with their role in clinic with the use of scribes, and more providers felt that with scribes they could listen sufficiently to patients (p <0.05). CONCLUSION: Scribe support was well received across the institution in multiple clinical settings. Benefits for providers were seen in documentation time and ability to listen to patients. Scribes appear to be an effective intervention for improving clinician work life.

A Prospective Observational Study of Patients Receiving Intravenous and Intramuscular Olanzapine in the Emergency Department.

STUDY OBJECTIVE: Parenteral olanzapine is an emerging therapy for a variety of conditions in the emergency department (ED). Intramuscular administration is standard; however, intravenous administration has been proposed as a safe alternative route. We investigate the safety and efficacy of both intramuscular and intravenous olanzapine in the ED when used for a variety of indications. METHODS: This was a prospective observational study of patients presenting to an urban Level I trauma center ED. Trained research associates screened the ED for patients receiving parenteral olanzapine. The primary outcome of the study was incidence of respiratory depression measured with standard markers. Secondary outcomes included use of additional doses or sedatives, corrected QT interval (QTc) data, time to nadir sedation, adverse events, and physician assessment of efficacy. RESULTS: There were 784 patients included in the final analysis. Intravenous olanzapine was administered to 295 patients; 489 received intramuscular olanzapine. Respiratory depression occurred in 11 of 295 patients (3.7%; 95% confidence interval [CI] 1.6% to 5.9%) receiving intravenous olanzapine and 10 of 489 (2.0%; 95% CI 0.8% to 3.3%) receiving intramuscular olanzapine. Seven patients required intubation, 2 in the intravenous group and 5 in the intramuscular group. Nonrespiratory complications occurred in 8 patients, 6 of 295 (2.0%; 95% CI 0.4% to 3.6%) in the intravenous group and 2 of 489 (0.4%; 95% CI 0% to 0.96%) in the intramuscular group. Dysrhythmias were isolated to 2 episodes of bradycardia requiring only supportive care. CONCLUSION: These data suggest that, with proper monitoring, administration of olanzapine, both intramuscular and intravenous, is safe for several indications in the ED.

Erector Spinae Plane Block in the Emergency Department for Upper Extremity: A Case Report.

INTRODUCTION: The erector spinae plane block (ESPB) has been described as an effective analgesic modality in the emergency department (ED) for thoracic pain. It has not previously been described to treat ED patients with pain in the upper extremity. CASE REPORT: We present a case of a 52-year-old female who presented to the ED with an acute exacerbation of her chronic radicular left arm pain originating after a fall she sustained one year prior. After a variety of analgesic modalities failed to control her pain, an ESPB was used to successfully treat her pain and facilitate discharge from the ED. CONCLUSION: A significant portion of patients who present to the ED have underlying chronic pain; however, opioids are a potentially dangerous and ineffective modality to treat chronic pain. In addition to avoiding opiates, the ESPB has the advantage of preserving motor function, thus avoiding the complications associated with brachial plexus blockade.

Randomized Double-blind Trial of Intramuscular Droperidol, Ziprasidone, and Lorazepam for Acute Undifferentiated Agitation in the Emergency Department.

BACKGROUND: The optimal agent to treat acute agitation in the emergency department (ED) has not been determined. The objective of this study was to compare the effectiveness and safety of intramuscular droperidol, ziprasidone, and lorazepam for acute agitation in the ED. METHODS: This was a randomized, double-blind trial of ED patients with acute agitation requiring parenteral sedation. The study was conducted under exception from informed consent (21 CFR 50.24) from July 2004 to March 2005. Patients were randomized to receive 5 mg of droperidol, 10 mg of ziprasidone, 20 mg of ziprasidone, or 2 mg of lorazepam intramuscularly. We recorded Altered Mental Status Scale (AMSS) scores, nasal end-tidal carbon dioxide (ETCO2 ), and pulse oximetry (SpO2 ) at 0, 15, 30, 45, 60, 90, and 120 minutes as well as QTc durations and dysrhythmias. Respiratory depression was defined as a change in ETCO2 consistent with respiratory depression or SpO2  < 90%. The primary outcome was the proportion of patients adequately sedated (AMSS ≤ 0) at 15 minutes. RESULTS: We enrolled 115 patients. Baseline AMSS scores were similar between groups. For the primary outcome, adequate sedation at 15 minutes, droperidol administration was effective in 16 of 25 (64%) patients, compared to seven of 28 (25%) for 10 mg of ziprasidone, 11 of 31 (35%) for 20 mg of ziprasidone, and nine of 31 (29%) for lorazepam. Pairwise comparisons revealed that droperidol was more effective that the other medications, with 39% (95% confidence interval [CI] = 3% to 54%) more compared to 20 mg of ziprasidone and 33% (95% CI = 8% to 58%) more compared to lorazepam. There was no significant difference between groups in need of additional rescue sedation. Numerically, respiratory depression was lower with droperidol (3/25 [12%]) compared to 10 mg of ziprasidone (10/28 [36%]), 20 mg of ziprasidone (12/31 [39%]), or lorazepam (15/31 [48%]). One patient receiving 20 mg of ziprasidone required intubation to manage an acute subdural hematoma. No patients had ventricular dysrhythmias. QTc durations were similar in all groups. CONCLUSIONS: Droperidol was more effective than lorazepam or either dose of ziprasidone for the treatment of acute agitation in the ED and caused fewer episodes of respiratory depression.

The Incidence of QT Prolongation and Torsades des Pointes in Patients Receiving Droperidol in an Urban Emergency Department.

INTRODUCTION: Droperidol carries a boxed warning from the United States Food and Drug Administration for QT prolongation and torsades des pointes (TdP). After a six-year hiatus, droperidol again became widely available in the US in early 2019. With its return, clinicians must again make decisions regarding the boxed warning. Thus, the objective of this study was to report the incidence of QT prolongation or TdP in patients receiving droperidol in the ED. METHODS: Patients receiving droperidol at an urban Level I trauma center from 1997-2001 were identified via electronic health record query. All patients were reviewed for cardiac arrest. We reviewed electrocardiogram (ECG) data for both critically-ill and noncritical patients and recorded Bazett's corrected QT intervals (QTc). ECGs from critically-ill patients undergoing resuscitation were further risk-stratified using the QT nomogram. RESULTS: Of noncritical patients, 15,374 received 18,020 doses of droperidol; 2,431 had an ECG. In patients with ECGs before and after droperidol, the mean QTc was 424.3 milliseconds (ms) (95% confidence interval [CI], 419.7-428.9) before and 427.6 ms (95% CI, 424.3-430.9), after droperidol (n = 170). Regarding critically-ill patients, 1,172 received droperidol and 396 had an ECG. In the critically-ill group with ECGs before and after droperidol mean QTc was 435.7 ms (95% CI, 426.7-444.7) before and 435.8 ms (95% CI, 427.5-444.1) after droperidol (n = 114). Of 337 ECGs suitable for plotting on the QT nomogram, 13 (3.8%) were above the "at-risk" line; 3/136 (2.2%; 95% CI, 0.05-6.3%) in the before group, and 10/202 (4.9%; 95% CI, 2.4%-8.9%) in the after group. A single case of TdP occurred in a patient with multiple risk factors that did not reoccur after a droperidol rechallenge. Thus, the incidence of TdP was 1/16,546 (0.006%; 95% CI, 0.00015 - 0.03367%). CONCLUSION: We found the incidence of QTc prolongation and TdP in ED patients receiving droperidol to be extremely rare. Our data suggest the FDA "black box warning" is overstated, and that close ECG monitoring is useful only in high-risk patients.