Post-severe Acute Respiratory Syndrome Coronavirus 2 Monoclonal Antibody Treatment Hospitalizations as a Sentinel for Emergence of Viral Variants in New York City.

We partnered with the US Department of Health and Human Services to treat high-risk, nonadmitted coronavirus disease 2019 (COVID-19) patients with bamlanivimab in the Bronx, New York per Emergency Use Authorization criteria. Increasing posttreatment hospitalizations were observed monthly between December 2020 and March 2021 in parallel to the emergence of severe acute respiratory syndrome coronavirus 2 variants in New York City.

Randomized Clinical Trial of Intravenous (IV) Acetaminophen as an Adjunct to IV Hydromorphone for Acute Severe Pain in Emergency Department Patients.

BACKGROUND: A fundamental challenge for emergency department (ED) clinicians is to relieve severe, acute pain while simultaneously avoiding adverse events associated with opioid analgesics. Because there is evidence that intravenous (IV) acetaminophen is an effective adjuvant analgesic in postoperative settings, we examined whether it also has a role in the ED. METHODS: This was a two-arm, double-blind randomized clinical trial. All patients received 1 mg of IV hydromorphone. Patients were then randomized to receive 1 g of IV acetaminophen or placebo. The primary outcome was the between-group difference in change in pain from baseline (before treatment) to 60 minutes after administration of study drugs, measured on an 11-point numeric rating scale (NRS). RESULTS: Of 828 patients screened, 162 were enrolled and 159 had the primary outcome. Patients allocated to acetaminophen + hydromorphone had a mean decline in pain from baseline to 60 minutes of 6.2 NRS units; those receiving placebo + hydromorphone had a mean decline of 5.4, a difference of 0.8 NRS units (95% confidence interval [CI] = -0.01 to 1.8). Two patients in each group received additional analgesics in the first 60 minutes of the study. At 120 minutes the NRS pain difference was 0.6 (95% CI = -0.4 to 1.6). A total of 26.9% of patients who received acetaminophen wanted more analgesia versus 37.7% of those given placebo (difference = -10.8%, 95% CI = -24.3% to 4.4%). The incidence of adverse effects was similar in both groups. CONCLUSIONS: The addition of 1 g of IV acetaminophen to 1 mg of IV hydromorphone provided neither clinically meaningful nor statistically superior analgesia than hydromorphone alone.

A Randomized, Placebo-Controlled Trial of Ibuprofen Plus Metaxalone, Tizanidine, or Baclofen for Acute Low Back Pain.

STUDY OBJECTIVE: Patients with low back pain are often treated with nonsteroidal anti-inflammatory drugs and skeletal muscle relaxants. We compare functional outcomes and pain among patients with acute low back pain who were randomized to a 1-week course of ibuprofen plus placebo versus ibuprofen plus 1 of 3 skeletal muscle relaxants: baclofen, metaxalone, and tizanidine. METHODS: This was a randomized, double-blind, parallel-group, 4-arm study conducted in 2 urban emergency departments (EDs). Patients with nonradicular low back pain for less than or equal to 2 weeks were eligible if they had a score greater than 5 on the Roland-Morris Disability Questionnaire, a 24-item inventory of functional impairment caused by low back pain. All participants received 21 tablets of ibuprofen 600 mg, to be taken 3 times a day as needed. Additionally, they were randomized to baclofen 10 mg, metaxalone 400 mg, tizanidine 2 mg, or placebo. Participants were instructed to take 1 or 2 of these capsules 3 times a day as needed. All participants received a 10-minute educational session. The primary outcome was improvement on the Roland-Morris Disability Questionnaire between ED discharge and 1week later. Secondary outcomes included pain intensity 1 week after ED discharge (severe, moderate, mild, or none). RESULTS: Three hundred twenty patients were randomized. One week later, the mean Roland-Morris Disability Questionnaire score of patients randomized to placebo improved by 11.1 points (95% confidence interval [CI] 9.0 to 13.3), baclofen by 10.6 points (95% CI 8.6 to 12.7), metaxalone by 10.1 points (95% CI 8.0 to 12.3), and tizanidine by 11.2 points (95% CI 9.2 to 13.2). At 1-week follow-up, 30% of placebo patients (95% CI 21% to 41%) reported moderate to severe low back pain versus 33% of baclofen patients (95% CI 24% to 44%), 37% of metaxalone patients (95% CI 27% to 48%), and 33% of tizanidine patients (95% CI 23% to 44%). CONCLUSION: Adding baclofen, metaxalone, or tizanidine to ibuprofen does not appear to improve functioning or pain any more than placebo plus ibuprofen by 1 week after an ED visit for acute low back pain.

Randomized Trial of Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain in the Emergency Department.

STUDY OBJECTIVE: We compare the efficacy and safety of intravenous lidocaine with that of hydromorphone for the treatment of acute abdominal pain in the emergency department (ED). METHODS: This was a randomized, double-blind, clinical trial conducted in 2 EDs in the Bronx, NY. Adults weighing 60 to 120 kg were randomized to receive 120 mg of intravenous lidocaine or 1 mg of intravenous hydromorphone. Thirty minutes after administration of the first dose of the study drug, participants were asked whether they needed a second dose of the investigational medication to which they were randomized. Patients were also stratified according to clinical suspicion of nephrolithiasis. The primary outcome was improvement in pain scores of 0 to 10 between baseline and 90 minutes. An important secondary outcome was need for "off-protocol" parenteral analgesics, including opioids and nonsteroidal anti-inflammatory drugs. RESULTS: We enrolled 154 patients, of whom 77 received lidocaine and 77 received hydromorphone. By 90 minutes, patients randomized to lidocaine improved by a mean of 3.8 points on the 0-to-10 scale, whereas those randomized to hydromorphone improved by a mean of 5.0 points (mean difference 1.2; 95% confidence interval 0.3 to 2.2). Need for off-protocol "rescue" analgesics occurred for 39 of 77 lidocaine patients (51%) and 20 of 77 hydromorphone patients (26%) (difference 25%; 95% confidence interval 10% to 40%). Adverse events were comparable between groups. Among the subset of 22 patients with nephrolithiasis, lidocaine patients reported a mean improvement of 3.4 points on the pain scale, whereas hydromorphone patients reported a mean improvement of 6.4 points (mean difference 3.0; 95% confidence interval 0.5 to 5.5). CONCLUSION: Intravenous hydromorphone was superior to intravenous lidocaine both for general abdominal pain and a subset of patients with nephrolithiasis. A majority of patients randomly allocated to lidocaine required additional analgesics.

Generalizability and Effectiveness of Butterfly Phlebotomy in Reducing Hemolysis.

OBJECTIVES: The objective was to test the hypothesis that exclusive use of butterfly needles for phlebotomy, compared with sample collection via intravenous (IV) catheter, will reduce rates of sample hemolysis. METHODS: This was an observational study of hemolysis rates before and after implementation of a "butterfly-only" phlebotomy protocol. Weekly hemolysis rates, generated by the central laboratory, were collected and the proportion of hemolyzed specimens before and after protocol implementation were compared. RESULTS: Prior to institution of the butterfly-only protocol, 11.3% of specimens sent from the emergency department were reported as hemolyzed. During the postintervention period, only 4.3% of specimens were hemolyzed for a proportionate decrease of 62% and an absolute decrease of 7.0% (95% confidence interval = 6.6% to 7.3%). CONCLUSIONS: Use of a butterfly-only phlebotomy protocol cuts hemolysis rates by more than half when compared with IV catheter phlebotomy.

The association between headache and elevated blood pressure among patients presenting to an ED.

BACKGROUND: Elevated blood pressure (BP) and headache have long been linked in the medical literature, although data on association are conflicting. We used previously collected data to address these related aims: (1) using the National Hospital Ambulatory Medical Care Survey (NHAMCS), we determined whether elevated BP is more likely in patients who present to an emergency department (ED) with headache than in patients who present with other complaints; (2) using data collected in 3 ED-based migraine clinical trials, we determined the association between improvement in headache pain and improvement in BP among patients who present to an ED with migraine and elevated BP; (3) using the data from the migraine clinical trials, we also determined if an elevated baseline BP identifies a group of patients less likely to respond to standard migraine treatment. METHODS: We analyzed 2 distinct data sets. The first, NHAMCS, is a national probability sample of all US ED visits. The second is a compilation of data gathered during 3 ED-based migraine randomized controlled trials. We defined elevated BP as follows: moderate elevation-systolic BP (SBP) ≥150 mm Hg or diastolic BP (DBP) ≥95 mm Hg; marked elevation-SBP ≥165 mm Hg or DBP ≥100 mm Hg; and severe elevation-SBP ≥180 mm Hg or DBP ≥110 mm Hg. We report the association between headache and elevated BP in NHAMCS using odds ratios (ORs) with 95% confidence intervals (CI). We report the correlation coefficient and r(2) for the association between improvement in BP and improvement in headache pain in our clinical trials data set. Finally, using our clinical trials database, we determined the influence of elevated BP at baseline on response to migraine medication by constructing a linear regression model in which the dependent variable was improvement in 0 to 10 pain score between baseline and 1 hour, and the primary predictor variable was presence or absence of elevated BP at baseline. RESULTS: Headache was the primary complaint in 3.7% (95% CI, 3.4-4.0%) of all US ED visits, corresponding to 4.8 million (95% CI, 4.2-5.4 million) patient visits. Among US ED patients, those with headache were more likely than patients with other chief complaints to have markedly (OR, 1.37; 95% CI, 1.16-1.61) or severely elevated BP (OR, 1.49; 95% CI, 1.17-1.90). In our clinical trials data set of patients with migraine with moderately elevated BP, there was no correlation between improvement in pain score and improvement in SBP (r = -0.07, r(2) = 0, P = .465) or DBP (r = -0.03, r(2) = 0, P = .75). Similarly, there was no correlation between improvement in headache and improvement in BP among patients with migraine with markedly elevated BP (for SBP, r = -0.19, r(2) = 0.04, P = .89; for DBP, r = -0.02, r(2) = 0, P = .87), nor among patients with severely elevated BP (for SBP, r = 0.06, r(2) = 0, P = .81; for DBP, r = 0.03, r(2) = 0, P = .90). Patients with moderately elevated BP had slightly less improvement in their 0 to 10 pain score than patients with BPs below this cutoff (-0.6; 95% CI, -1.2 to -0.1; P = .03). This was more pronounced among patients with markedly elevated BP (-0.9; 95% CI, -1.7 to -0.2). CONCLUSIONS: Although there is an association between elevated BP and headache among patients presenting to an ED, improvement in headache is not associated with improvement in BP.

Randomized trial of IV valproate vs metoclopramide vs ketorolac for acute migraine.

OBJECTIVE: We compared the efficacy of IV valproate with metoclopramide and with ketorolac in patients presenting to an emergency department (ED) with acute migraine. METHODS: This was a double-blind comparative efficacy trial. Patients were randomized to 1,000 mg sodium valproate, 10 mg metoclopramide, or 30 mg ketorolac, each administered as an IV drip over 15 minutes. The primary outcome was improvement in headache by 1 hour, measured on a verbal 0 to 10 scale, at baseline and 60 minutes later. Important secondary outcomes included (1) need for rescue medication in the ED, and (2) sustained headache freedom. RESULTS: Three hundred thirty patients were enrolled over 30 months beginning in October 2010. Baseline characteristics were comparable among the 3 arms. On the primary outcome, patients receiving IV valproate improved by a mean of 2.8 (95% confidence interval [CI]: 2.3, 3.3) on the 0 to 10 scale; those receiving IV metoclopramide improved by 4.7 (95% CI: 4.2, 5.2); and those receiving IV ketorolac improved by 3.9 (95% CI: 3.3, 4.5). On the secondary endpoints, 69% (95% CI: 60%, 78%) of patients receiving valproate required rescue medication, compared with 33% (95% CI: 24%, 42%) of metoclopramide patients and 52% (95% CI: 42%, 63%) of those assigned to ketorolac. Sustained headache freedom was achieved in 4% (95% CI: 0%, 7%) of those randomized to valproate, 11% (95% CI: 5%, 17%) of metoclopramide patients, and 16% (95% CI: 9%, 23%) receiving ketorolac. In the metoclopramide arm, 6% (95% CI: 3%, 12%) of patients reported feeling "very restless" after investigational medication administration. CONCLUSIONS: Valproate was less efficacious than either metoclopramide or ketorolac. Metoclopramide demonstrated superiority to ketorolac on several endpoints. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that in ED patients with acute migraine, IV valproate is inferior to metoclopramide or ketorolac in improving headache outcomes.

Use of butterfly needles to draw blood is independently associated with marked reduction in hemolysis compared to intravenous catheter.

OBJECTIVES: Hemolysis of blood samples drawn in the emergency department (ED) is a common problem that can interfere with timely diagnosis and appropriate treatment. The objective of this study was to identify the smallest number of remediable factors that independently increases the risk of hemolysis to design an effective strategy to address this issue. METHODS: This was a prospective, observational, cross-sectional study of blood specimens obtained by ED staff in an urban, academic, adult ED in a tertiary care center. The staff member who drew the specimen recorded data on a standardized data collection instrument about device (intravenous [IV] catheter or butterfly needle), needle size, anatomic site, fullness of collection tube, tourniquet time, and difficulty of venipuncture. Specimens were sent to the laboratory by a vacuum-powered tube system. A standard automated process that measures free hemoglobin was used to identify hemolysis. A multivariable logistic regression and a tabular analysis stratified by device were performed. Ninety-five percent confidence intervals (CIs) were calculated around the odds ratios (ORs) and around the difference between hemolysis rates. RESULTS: Data were collected on 5,118 blood specimens. There were 4,513 specimens with complete data on all characteristics of the blood draw included in the analyses. The overall hemolysis rate was 12.5% (95% CI = 11.6% to 13.5%), 14.6% in blood drawn from IV catheters and 2.7% from butterfly needles (difference = 11.9%; 95% CI = 10.2% to 13.4%). Device was the strongest independent predictor of hemolysis (OR = 7.7; 95% CI = 4.9 to 12.0). In specimens drawn by IV catheter, hemolysis was significantly higher when blood was drawn from locations other than the antecubital fossa, with small-gauge catheters, collection tubes ≤ half full, tourniquet time ≥ 1 minute, and difficult venipuncture. In contrast, none of these factors was associated with hemolysis when blood was drawn by butterfly needle. CONCLUSIONS: The device used to collect blood was the strongest independent predictor of hemolysis in blood samples drawn in the ED in this study. This finding suggests that the most effective strategy to reduce the rate of hemolysis in the ED is to use butterfly needles for phlebotomy rather than IV catheters.

Failure to validate the San Francisco Syncope Rule in an independent emergency department population.

STUDY OBJECTIVE: We conduct a prospective independent validation of the San Francisco Syncope Rule to identify emergency department (ED) syncope patients with short-term serious outcomes. METHODS: This was a prospective observational cohort study of adult patients presenting to a university hospital ED with acute syncope or near syncope. Patients meeting inclusion criteria as defined in the San Francisco Syncope Rule derivation were evaluated for 5 previously derived predictor variables: abnormal ECG result, shortness of breath, hematocrit level less than 30%, triage systolic blood pressure less than 90 mm Hg, and history of congestive heart failure. Hospital admission occurred at the discretion of the emergency physician, independent of the decision rule. Follow-up occurred through contact with the inpatient attending physician for admitted patients and by telephone contact with patients not hospitalized or those hospitalized and discharged before day 7. Predetermined outcome measures as defined by the San Francisco Syncope Rule were death, myocardial infarction, arrhythmia, pulmonary embolism, stroke, subarachnoid hemorrhage, significant hemorrhage, or any condition causing or likely to cause a return ED visit and hospitalization for a related event. RESULTS: Complete predictor and follow-up data were available for 713 of 743 (96%) enrolled patients. Sixty-one of 713 (9%) patients met predetermined criteria for serious outcome. Sixteen of 61 (26%; 95% confidence interval [CI] 16% to 39%) patients with a serious outcome were not identified as high risk by the rule. Rule performance to predict serious outcomes was sensitivity 74% (95% CI 61% to 84%), specificity 57% (95% CI 53% to 61%); negative likelihood ratio 0.5 (95% CI 0.3 to 0.7) and positive likelihood ratio 1.7 (95% CI 1.4 to 2.0). CONCLUSION: In this independent validation study, sensitivity and negative likelihood ratio of the San Francisco Syncope Rule were substantially lower than reported in the original studies and suggest that the rule has limited generalizability.