reported an HRSN: 17 (15%) reported housing instability, 22 (17%) reported food insecurity, 14 (11%) reported transportation needs, 8 (6%) reported utility needs, and 19 (15%) reported interpersonal safety concerns.In unadjusted analyses, HRSN were not associated with location of enrollment (Fast Track or Pediatrics) or sex, but were associated with language.In a multivariable model adjusting for location and sex, language remained significantly associated with presence of any HRSN ).Conclusions: Almost one-third of ED patients reported an HRSN in this pilot study, with Spanish-speaking patients at significantly higher risk.These data demonstrate the importance of HRSN screening in the ED, while also highlighting the significance of ensuring that screening programs and referral resources are accessible to non-English-speaking patients.
reported an HRSN: 17 (15%) reported housing instability, 22 (17%) reported food insecurity, 14 (11%) reported transportation needs, 8 (6%) reported utility needs, and 19 (15%) reported interpersonal safety concerns.In unadjusted analyses, HRSN were not associated with location of enrollment (Fast Track or Pediatrics) or sex, but were associated with language.In a multivariable model adjusting for location and sex, language remained significantly associated with presence of any HRSN ).Conclusions: Almost one-third of ED patients reported an HRSN in this pilot study, with Spanish-speaking patients at significantly higher risk.These data demonstrate the importance of HRSN screening in the ED, while also highlighting the significance of ensuring that screening programs and referral resources are accessible to non-English-speaking patients.
Pulmonary embolism (PE) is an important cause of morbidity and mortality. Guidelines for the diagnosis and treatment of PE in adults use D-dimer testing to aid in risk stratification. Currently, the usefulness of D-dimer assays for PE in children is unknown. This study aims to evaluate the use of D-dimer in pediatric patients with a radiographically diagnosed PE and suspected PE. This is a sub-analysis of a retrospective chart-review of patients ≤ 21 years, presenting with a PE diagnosed by CTA or high-probability VQ. Data was collected from 1 ED/hospital from 1996 to 2016 and from another 3 ED/hospitals across 2 states from 2013-2016. D-dimer results from pediatric patients with a PE were compared with a control group of high-risk pediatric patients being evaluated for suspected PE by CTA. Out of 144 patients, 45.1% (65/144) had a radiographically confirmed PE and 54.9% (79/144) had suspected but negative PE by CTA. Of patients with a radiographically confirmed PE, 96.9% (63/65) were diagnosed by CTA and 3.08% (2/65) high-probability VQ. There were no significant differences in demographics for PE versus suspected PE patients: median age 19.3 (range 13.5-21.9) versus 18.9 (range 10.0-21.9), female 70.8% (46/65) versus 69.6% (55/79), Caucasian 56.9% (37/65) versus 53.2% (42/79), African American 36.9% (24/65) versus 27.8% (22/79), and other 4.62% (3/65) versus 3.80% (3/79). D-dimers drawn less than 4 days from onset of symptoms were obtained in 69.2% (45/65) of patients with PE and 98.7% (78/79) patients without PE. Elevated D-dimers (>500 ng/mL FEU) were found in 88.9% (40/45) of patients with PE and 87.2% (68/78) with suspected PE. Median D-dimer with PE 1,825 (range 99-19,980) versus no PE 721 (range 99-6,140) (p=0.0002*). D-dimers were falsely-negative in 11.1% (5/45) patients with PE. PE were located in the central pulmonary artery in 31.1% (14/45) and peripheral arteries 68.9% (31/45). Central PE D-dimer 4,075 median (range 460-35,201) versus peripheral 3,160 (range 99-19,980) (p=0.0015*) versus No PE 715 (range 99-6,140) (p=<0.001*). Ultrasound was ordered for 67.7% (44/65) of patients with PE. DVT concurrent with PE was present in 20.5% (9/44). Unilateral extremity DVT was present in 66.7% (6/9) and 33.3% (3/9) had bilateral extremity DVT. D-dimer in pediatric patients with PE had a sensitivity and specificity of 88.9% and 12.8% respectively with a positive predictive value of 37.0% compared to a negative predictive value of 66.7%. Although D-dimers were higher in pediatric patients with PE than in high-risk suspected PE patients, there was a high incidence of false-negative (11.1%) as well as false-positives (87.2%). Patients with central PE had higher D-dimers than those with peripheral PE. D-dimer in pediatric patients with PE is sensitive but not specific.Tabled 1Characteristics of patients with a false-negative D-dimerD-dimer ng/mL FEUAge (years)SexChief complaintHistory9916.1FAcute onset SOBOCP 20-year-old cousin died from a blood clot13721.3FAcute onset pleuritic CP, palpitationsCongenital adrenal hyperplasia19021.9FAcute SOB, non-pleuritic CP, hemoptysisInjectable hormonal birth-control46018.5FNon-pleuritic CP, hemoptysisOCP Brother: sickle-cell trait49916.9MAcute onset SOBCongenital pulmonary stenosisGrandfather died of HCM Open table in a new tab
Venous thromboembolism (VTE) in hospitalized acute medically ill patients is a leading preventable cause of in-hospital morbidity and mortality in the US. Advancing age (>70 y) is one of the risk factors for VTE, and guidelines for diagnosis of VTE in these patients incorporate D-dimer for risk stratification. The DAMIACT study has previously described that the majority of acute medically ill patients without suspected VTE had elevated D-dimer levels, 74.4% of patients, with levels ≥2xULN in 48.8% of patients. Age adjusted elevations (≥age*10) were found in 62.2% of patients. The goal of this analysis was to evaluate D-dimer levels across the three common age ranges utilized for VTE risk assessment. DAMIACT was a prospective observational study of hospitalized acute medically ill patients admitted Feb 14-Nov 15, 2016, across 9 US hospitals. Eligibility criteria were ≥60 y and acute medical illness; exclusion criteria were suspected or diagnosed VTE, anticoagulation prior to enrollment, or surgery within 30 d of presentation. After consent, a single D-dimer sample was drawn within 24 h of admission and before receiving anticoagulation. Samples were analyzed in a single central laboratory. Results were stratified across three age groups: 60-64, 65-74, ≥75 y. Outcomes included assessments of D-dimer levels, presence of VTE, and anticoagulation therapy. Of 995 patients included (60-64 y, n=322; 65-74 y, n=415; ≥75 y, n=258), 49% were male; patients ≥75 vs. <75 y were mostly Caucasian (82% vs. 68%) while fewer were African-American (16% vs. 30%). D-dimer levels ranged from <220 ng/mL to >20,000 ng/mL, and increased significantly with age (Table). The increase in D-dimer levels with advancing age remained significant between patients <75 and ≥75 y when using an age-adjusted D-dimer cutoff. There was no difference in the proportion of patients who had in-hospital VTE event across all age groups (Table). Preliminary analyses showed that there was no difference in the proportion of patients receiving any anticoagulant during hospitalization (Table). More patients ≥75 vs. <75 y received heparin, 59.3% vs. 49.4% (p=0.006; 95% CI, 1.12-1.99). In hospitalized acute medically ill patients without suspected VTE, D-dimer levels increased with advancing age, without an increase in in-hospital VTE events. Proportion of patients who received anticoagulation was similar across all age groups, but older patients (≥75 y) were more likely to receive heparin. Further analyses may provide more insights into understanding the relationship between D-dimer levels, age, anticoagulation therapy, and VTE events.TableD-dimer levels, VTE events, and anticoagulation therapy in hospitalized patientsAge 60-64 y (n=322)Age 65-74 y (n=415)Age ≥75 y (n=258)P-value (95% CI) 60-64 vs. 65-74P-value (95% CI) 65-74 vs. ≥75P-value (95% CI) <75 vs. ≥75Median D-dimer levels, ng/mL (25th, 75th percentile)720 (370, 1680)970 (490, 2000)1280 (690, 2380)0.00040.0008<0.0001D-dimer above normal (≥500 ng/mL), n (%)206 (64.0)310 (74.7)224 (86.8)0.002 (1.21-2.28)0.0002 (1.46-3.41)<0.0001 (1.90-4.18)D-dimer above 2xULN (≥1000 ng/mL), n (%)126 (39.1)206 (49.6)154 (59.7)0.005 (1.14-2.06)0.011 (1.10-2.06)<0.0001 (1.35-2.41)D-Dimer age adjusted (≥age*10), n (%)180 (55.9)262 (63.1)177 (68.6)0.047 (1.00-1.82)0.15 (0.92-1.78)0.014 (1.08-1.97)In-hospital VTE events, n (%)4 (1.2)6 (1.5)5 (1.9)1.00 (0.33-4.17)0.76 (0.41-4.46)0.55 (0.49-4.24)Post-admission anticoagulant, n (%)209 (64.9)276 (66.5)182 (70.5)0.65 (0.79-1.46)0.27 (0.86-1.69)0.16 (0.91-1.69)Post-admission heparin, n (%)154 (47.8)211 (50.8)153 (59.3)0.42 (0.84-1.51)0.032 (1.03-1.93)0.006 (1.12-1.99) Open table in a new tab
Observation units (OUs) improve patient outcomes, decrease cost, and increase ED efficiency. Unlike adults, characteristics of OUs have not been well delineated for the pediatric population. This study characterizes pediatric OUs (POUs). Telephone/email survey sent July-December 2016 to 194 US pediatric residency programs. Sub-analysis of AHA database information also done. Survey response rate 60%(116/194). Results: median (range): ED census 53,500 (7,300-207,377), ED admissions 12% (4%-25%). 56% diverted ambulances, 77% rarely, 15% sometimes, 8% daily. 75% used midlevel providers (MLPs), 17% nurse practitioners (NPs), 12% physician assistants (PAs), 71% both. 24% (28/116) of hospitals placed pediatric patients in an OU or plan to open POU: pediatric patients only (POU) 12%, combined pediatric/adult patients OU (COU) 6%, planned POU 6%. If no POU, pediatric observation status patients were placed in ED (7%), scattered throughout inpatient floors (93%). Reasons for not having POU: lack administrative support (34%), space (32%), staff (7%), finances (3%), combination (24%). Of hospitals with POUs, median 7% (1%-10%) of ED patients placed in POU. Location: within/next to ED (71%), inpatient floor (29%). POU beds median 12 (4-27), patient to nurse ratio 4:1 (3:1-6:1). 50% used MLPs (66% NPs, 33% both). POU existed median 5 years (range 0-26 years): < 1 year (8%), 1-5 years (38%), 5-10 years (31%), 10-15 years (8%) >24 years (15%). 46% of POUs have existed <5 years. Patients cared for: ED (29%), pediatrics (21%), ED/pediatrics (43%), pediatric medical/surgical (7%). 80% used residents. Administration: ED (71%), pediatrics (29%). Top 5 conditions: respiratory distress (15%), asthma (11%), gastroenteritis (11%), appendicitis (9%), bronchiolitis (9%). Age exclusions: newborns (24%), infants (24%). 92% other exclusions: 64% psychiatric, 27% psychiatric/surgical, 9% surgical; 50% held inpatients; 92% sometimes, 8% rarely. Hospitals with POU vs no POU: ED inpatient admissions median 17% (10%-20%) vs. 10% (4%-25%) (p=0.0099*), annual ED census 47,500 (12,775-90,000) vs. 52,500 (7,300-127,000) (p=0.57, NS). 40% used MLP vs. 83% (p=0.0295*). AHA database available for 92 of 116 hospitals. 83% (69/92) hospitals provided primarily general medical care (GH): 7% (5/69) dedicated POU, 6% (4/69) COU. GH with dedicated POU vs no POU: inpatient beds median 835 (528-926) vs. 630 (268-973) (p=0.013*), annual admissions 39,804 (28,535-62,342) vs. 30,790 (16,940-47,988) (p=0.0004*). 17% (20/92) hospitals provided primarily children’s general medical/surgical services (CGH): 25% (5/20) POU. CGH with POU vs no POU: outpatient census median 515,164 (301,203-1,116,771) vs. 206,864 (133,758-447,619) (p=0.014*). Total hospital personnel median 5,025 (2,038-7,408) vs. 2,566 (1,593-4,853) (p=0.030*). Nearly 1/3 of pediatric residency program associated hospitals place pediatric patients in a dedicated OU or plan to open one.
Study ObjectivesThe expansion of health care coverage has increased discussions about inappropriate emergency department (ED) utilization. Little is known about the ED referral patterns of patients by health care professionals (HCP) [physician office clinic, on-call hotline, or nurse on-call] and the appropriateness of the referral by the HCP or the appropriateness of patient self-referral among those with and without a primary care provider (PCP). We sought to determine whether ED patients contacted a HCP prior to ED presentation or if they self-referred as well as ascertain whether there were any differences in admission rates (hospital or ED observation unit) between HCP referred and self-referred patients.MethodsThis was a convenience sample of patients who presented to an urban, academic, tertiary care ED of a large integrated health system. Patients were enrolled in June 2014 by trained research assistants present in the ED during the business hours of local clinics/offices (Monday through Friday, 8a-5p). Inclusion criteria were English speaking, non-psychiatric patients >18 years of age, willing to consent, and not pregnant or critically ill. A standard survey form was used to record whether patients had a PCP and were referred by a HCP for their presenting problem. Information about acuity, demographics, and disposition were obtained from the electronic medical record (EMR). All analysis was descriptive.ResultsThere were 672 patients who met inclusion criteria, and 511 (76%) consented. Mean age was 53 (SD 19), 57% were female and 50% were black. Overall, 242/511 (47%) reported contacting a HCP prior to their ED visit and 202/242 (83%) were referred by the HCP to the ED. Of these, 106/202 (53%) were admitted, compared to 90/309 (29%) of self-referred patients. The majority (95%) of HCP referred patients had an emergency severity index (ESI) of 2 or 3, compared to 74% in self-referred patients. There were 40/242 (17%) patients who contacted an HCP and were not referred to the ED, yet who subsequently self-referred. Of these, 12/40 (30%) were admitted. Most patients, 414/511 (81%) reported having a PCP. Of these, 215/414 (52%) contacted a HCP prior to the ED visit and 183/414 (44%) were referred by the HCP to the ED. Of those without a PCP, 27/97 (28%) contacted a HCP prior to the ED visit, 19/27 (70%) were referred to the ED, and 8/27 (30%) were not referred, and subsequently self-referred. Patients with a PCP had an admission rate of 43% compared to 19% in those without. Of those with a PCP, 73% of HCP-referred patients and 68% of self-referred patients saw a HCP within the past 3 months.ConclusionIn this study conducted when outpatient clinics were open, nearly one-half of all patients contacted a HCP prior to their ED visit. Importantly, almost one-third of patients without a PCP also contacted a HCP prior to their ED visit. Based on admission rates and acuity it appears that HCPs appropriately refer to the ED; however, some patients should have been referred and were not. It is unlikely that these patients could have been treated in an alternate venue such as a walk-in clinic or PCP office. Despite popular sentiment to the contrary, many ED patients (with and without a PCP) attempt to use available resources prior to ED presentation. In addition, when indicated, patients appropriately seek timely emergent care unavailable in other settings. ED patients belong in the ED. Study ObjectivesThe expansion of health care coverage has increased discussions about inappropriate emergency department (ED) utilization. Little is known about the ED referral patterns of patients by health care professionals (HCP) [physician office clinic, on-call hotline, or nurse on-call] and the appropriateness of the referral by the HCP or the appropriateness of patient self-referral among those with and without a primary care provider (PCP). We sought to determine whether ED patients contacted a HCP prior to ED presentation or if they self-referred as well as ascertain whether there were any differences in admission rates (hospital or ED observation unit) between HCP referred and self-referred patients. The expansion of health care coverage has increased discussions about inappropriate emergency department (ED) utilization. Little is known about the ED referral patterns of patients by health care professionals (HCP) [physician office clinic, on-call hotline, or nurse on-call] and the appropriateness of the referral by the HCP or the appropriateness of patient self-referral among those with and without a primary care provider (PCP). We sought to determine whether ED patients contacted a HCP prior to ED presentation or if they self-referred as well as ascertain whether there were any differences in admission rates (hospital or ED observation unit) between HCP referred and self-referred patients. MethodsThis was a convenience sample of patients who presented to an urban, academic, tertiary care ED of a large integrated health system. Patients were enrolled in June 2014 by trained research assistants present in the ED during the business hours of local clinics/offices (Monday through Friday, 8a-5p). Inclusion criteria were English speaking, non-psychiatric patients >18 years of age, willing to consent, and not pregnant or critically ill. A standard survey form was used to record whether patients had a PCP and were referred by a HCP for their presenting problem. Information about acuity, demographics, and disposition were obtained from the electronic medical record (EMR). All analysis was descriptive. This was a convenience sample of patients who presented to an urban, academic, tertiary care ED of a large integrated health system. Patients were enrolled in June 2014 by trained research assistants present in the ED during the business hours of local clinics/offices (Monday through Friday, 8a-5p). Inclusion criteria were English speaking, non-psychiatric patients >18 years of age, willing to consent, and not pregnant or critically ill. A standard survey form was used to record whether patients had a PCP and were referred by a HCP for their presenting problem. Information about acuity, demographics, and disposition were obtained from the electronic medical record (EMR). All analysis was descriptive. ResultsThere were 672 patients who met inclusion criteria, and 511 (76%) consented. Mean age was 53 (SD 19), 57% were female and 50% were black. Overall, 242/511 (47%) reported contacting a HCP prior to their ED visit and 202/242 (83%) were referred by the HCP to the ED. Of these, 106/202 (53%) were admitted, compared to 90/309 (29%) of self-referred patients. The majority (95%) of HCP referred patients had an emergency severity index (ESI) of 2 or 3, compared to 74% in self-referred patients. There were 40/242 (17%) patients who contacted an HCP and were not referred to the ED, yet who subsequently self-referred. Of these, 12/40 (30%) were admitted. Most patients, 414/511 (81%) reported having a PCP. Of these, 215/414 (52%) contacted a HCP prior to the ED visit and 183/414 (44%) were referred by the HCP to the ED. Of those without a PCP, 27/97 (28%) contacted a HCP prior to the ED visit, 19/27 (70%) were referred to the ED, and 8/27 (30%) were not referred, and subsequently self-referred. Patients with a PCP had an admission rate of 43% compared to 19% in those without. Of those with a PCP, 73% of HCP-referred patients and 68% of self-referred patients saw a HCP within the past 3 months. There were 672 patients who met inclusion criteria, and 511 (76%) consented. Mean age was 53 (SD 19), 57% were female and 50% were black. Overall, 242/511 (47%) reported contacting a HCP prior to their ED visit and 202/242 (83%) were referred by the HCP to the ED. Of these, 106/202 (53%) were admitted, compared to 90/309 (29%) of self-referred patients. The majority (95%) of HCP referred patients had an emergency severity index (ESI) of 2 or 3, compared to 74% in self-referred patients. There were 40/242 (17%) patients who contacted an HCP and were not referred to the ED, yet who subsequently self-referred. Of these, 12/40 (30%) were admitted. Most patients, 414/511 (81%) reported having a PCP. Of these, 215/414 (52%) contacted a HCP prior to the ED visit and 183/414 (44%) were referred by the HCP to the ED. Of those without a PCP, 27/97 (28%) contacted a HCP prior to the ED visit, 19/27 (70%) were referred to the ED, and 8/27 (30%) were not referred, and subsequently self-referred. Patients with a PCP had an admission rate of 43% compared to 19% in those without. Of those with a PCP, 73% of HCP-referred patients and 68% of self-referred patients saw a HCP within the past 3 months. ConclusionIn this study conducted when outpatient clinics were open, nearly one-half of all patients contacted a HCP prior to their ED visit. Importantly, almost one-third of patients without a PCP also contacted a HCP prior to their ED visit. Based on admission rates and acuity it appears that HCPs appropriately refer to the ED; however, some patients should have been referred and were not. It is unlikely that these patients could have been treated in an alternate venue such as a walk-in clinic or PCP office. Despite popular sentiment to the contrary, many ED patients (with and without a PCP) attempt to use available resources prior to ED presentation. In addition, when indicated, patients appropriately seek timely emergent care unavailable in other settings. ED patients belong in the ED. In this study conducted when outpatient clinics were open, nearly one-half of all patients contacted a HCP prior to their ED visit. Importantly, almost one-third of patients without a PCP also contacted a HCP prior to their ED visit. Based on admission rates and acuity it appears that HCPs appropriately refer to the ED; however, some patients should have been referred and were not. It is unlikely that these patients could have been treated in an alternate venue such as a walk-in clinic or PCP office. Despite popular sentiment to the contrary, many ED patients (with and without a PCP) attempt to use available resources prior to ED presentation. In addition, when indicated, patients appropriately seek timely emergent care unavailable in other settings. ED patients belong in the ED.
The purpose of this report is to describe the scope of clinical services provided by emergency medicine (EM) pharmacists in a tertiary academic medical center. The primary objective is to describe and categorize pharmacist interventions and clinical activities. Secondary objectives are to categorize drug therapy recommendations based on therapeutic class of medication and to determine the percentage of emergency department (ED) patients for whom an intervention was documented. This was a retrospective, single-center, chart review conducted in the emergency department of an urban tertiary care center with approximately 65,000 patient visits per year. EM pharmacists provided dedicated support daily within two shift assignments from 0700 to 2300 and documented interventions and clinical activities in the electronic health record (EHR). As part of the usual care process and departmental procedures, all interventions and clinical activities by EM pharmacists are documented electronically within discrete fields in the EHR. All interventions and clinical activities from January 1, 2015 through March 31, 2015 were abstracted via electronic data pull for further analysis by a trained reviewer. All data were analyzed descriptively. A total of 3739 interventions and clinical activities were documented by EM pharmacists, with a mean of 41.5 ± 13.3 (mean ± standard deviation) documented per day. Categorization of interventions and clinical activities is summarized in Table 1. Of the 1165 drug therapy recommendations, a total of 986 were linked within the EHR to a therapeutic class of medication. For these 986 drug therapy recommendations, the most frequently implicated therapeutic classes were antimicrobial agents (31.9%), cardiovascular agents (16.2%), analgesic agents (12.6%), central nervous system agents (8.1%), and antihyperglycemic agents (6.2%). EM pharmacists documented interventions for 11.7% of emergency department patients during the study period. EM pharmacists documented multiple types of interventions and clinical activities in a tertiary medical center with 66% of documentation relating to drug therapy recommendations and medication histories. These documented interventions demonstrate the role of EM pharmacists in optimizing medication therapy to improve patient safety.
Study ObjectivesPrior research has documented that health care providers often provide inadequate anesthesia for patients with painful conditions and fail to use anesthetics before doing painful procedures. Patients in the emergency department (ED) often undergo painful procedures, such as the placement of a peripheral intravenous line (PIV). The study objective is to determine if topical anesthetics are effective and safe in ED patients. We hypothesize that a topical anesthetic spray will decrease the pain associated with PIV placement and is safe with no permanent skin discoloration.MethodsThis was a prospective, blinded, randomized, placebo-controlled efficacy and safety trial of vapocoolant spray on pain in adults ≥ 21 years undergoing PIVs in a large urban tertiary care hospital ED. Numeric rating scale (NRS) from 1 - 10 was done after spray application and PIV placement in adults (randomized to normal saline (S) placebo or vapocoolant (V) spray (1,1,1,3,3 pentafluoropropane and 1,1,1,2 tetrafluoroethane, Gebauer Pain-Ease). Safety assessment included vital signs; a checklist for pallor, redness, etc, and photographs of the site before and after spray application/PIV. Side effects were noted. NRS for (S) versus (V) was compared by the Mann-Whitney test. Preliminary findings are reported. The trial is ongoing with anticipated enrollment of 300.ResultsWe have enrolled 155 adults (age ≥ 21 years) undergoing PIV in the ED: 77 (S), 78 (V). The demographics and vital signs were not significantly different for the two groups: mean age in years: (S) 48 versus (V) 54, % male: (S) 43% versus 40% (V), Caucasian (S) 40% versus 42% (V), African-American: (S) 60% versus 58% (V). The results post spray/post venipuncture were mean (±SD): NRS 4.4 (±3.0) (S) versus NRS 1.9 (±2.4) (V) (P<0.001) with a [P25, P75] of [2, 7] for (S) versus [0, 3] for (V). The skin checklist and before/after photographs of the skin revealed no redness, pallor or other skin abnormalities in either the (S) or the (V) groups. The mean (± SD) NRS post spray was (S) 0.8 (± 3.1) versus (V) 2.1 (± 2.2) (P< 0.001). There were only 6 minor complaints that all resolved quickly. Four patients felt cool: two (S) patients (2.6% = 2/77) and two (V) patients (2/78 = 2.6%) and two other (V) patients (2/78 = 2.6%) complained of redness.discomfort. Total side effects were (S) 2.6% and (V) 5.2% (4/78).ConclusionVapocoolant is safe and effective in decreasing the pain due to IV cannulation in adults in the ED underging placement of a peripheral IV line with a significant decrease of 2.5 in the NRS compared to saline placebo spray (saline 4.4 NRS versus vapocoolant 1.9 NRS). There were no skin abnormalities noted post spray/post PIV by checklist and by photograph. Study ObjectivesPrior research has documented that health care providers often provide inadequate anesthesia for patients with painful conditions and fail to use anesthetics before doing painful procedures. Patients in the emergency department (ED) often undergo painful procedures, such as the placement of a peripheral intravenous line (PIV). The study objective is to determine if topical anesthetics are effective and safe in ED patients. We hypothesize that a topical anesthetic spray will decrease the pain associated with PIV placement and is safe with no permanent skin discoloration. Prior research has documented that health care providers often provide inadequate anesthesia for patients with painful conditions and fail to use anesthetics before doing painful procedures. Patients in the emergency department (ED) often undergo painful procedures, such as the placement of a peripheral intravenous line (PIV). The study objective is to determine if topical anesthetics are effective and safe in ED patients. We hypothesize that a topical anesthetic spray will decrease the pain associated with PIV placement and is safe with no permanent skin discoloration. MethodsThis was a prospective, blinded, randomized, placebo-controlled efficacy and safety trial of vapocoolant spray on pain in adults ≥ 21 years undergoing PIVs in a large urban tertiary care hospital ED. Numeric rating scale (NRS) from 1 - 10 was done after spray application and PIV placement in adults (randomized to normal saline (S) placebo or vapocoolant (V) spray (1,1,1,3,3 pentafluoropropane and 1,1,1,2 tetrafluoroethane, Gebauer Pain-Ease). Safety assessment included vital signs; a checklist for pallor, redness, etc, and photographs of the site before and after spray application/PIV. Side effects were noted. NRS for (S) versus (V) was compared by the Mann-Whitney test. Preliminary findings are reported. The trial is ongoing with anticipated enrollment of 300. This was a prospective, blinded, randomized, placebo-controlled efficacy and safety trial of vapocoolant spray on pain in adults ≥ 21 years undergoing PIVs in a large urban tertiary care hospital ED. Numeric rating scale (NRS) from 1 - 10 was done after spray application and PIV placement in adults (randomized to normal saline (S) placebo or vapocoolant (V) spray (1,1,1,3,3 pentafluoropropane and 1,1,1,2 tetrafluoroethane, Gebauer Pain-Ease). Safety assessment included vital signs; a checklist for pallor, redness, etc, and photographs of the site before and after spray application/PIV. Side effects were noted. NRS for (S) versus (V) was compared by the Mann-Whitney test. Preliminary findings are reported. The trial is ongoing with anticipated enrollment of 300. ResultsWe have enrolled 155 adults (age ≥ 21 years) undergoing PIV in the ED: 77 (S), 78 (V). The demographics and vital signs were not significantly different for the two groups: mean age in years: (S) 48 versus (V) 54, % male: (S) 43% versus 40% (V), Caucasian (S) 40% versus 42% (V), African-American: (S) 60% versus 58% (V). The results post spray/post venipuncture were mean (±SD): NRS 4.4 (±3.0) (S) versus NRS 1.9 (±2.4) (V) (P<0.001) with a [P25, P75] of [2, 7] for (S) versus [0, 3] for (V). The skin checklist and before/after photographs of the skin revealed no redness, pallor or other skin abnormalities in either the (S) or the (V) groups. The mean (± SD) NRS post spray was (S) 0.8 (± 3.1) versus (V) 2.1 (± 2.2) (P< 0.001). There were only 6 minor complaints that all resolved quickly. Four patients felt cool: two (S) patients (2.6% = 2/77) and two (V) patients (2/78 = 2.6%) and two other (V) patients (2/78 = 2.6%) complained of redness.discomfort. Total side effects were (S) 2.6% and (V) 5.2% (4/78). We have enrolled 155 adults (age ≥ 21 years) undergoing PIV in the ED: 77 (S), 78 (V). The demographics and vital signs were not significantly different for the two groups: mean age in years: (S) 48 versus (V) 54, % male: (S) 43% versus 40% (V), Caucasian (S) 40% versus 42% (V), African-American: (S) 60% versus 58% (V). The results post spray/post venipuncture were mean (±SD): NRS 4.4 (±3.0) (S) versus NRS 1.9 (±2.4) (V) (P<0.001) with a [P25, P75] of [2, 7] for (S) versus [0, 3] for (V). The skin checklist and before/after photographs of the skin revealed no redness, pallor or other skin abnormalities in either the (S) or the (V) groups. The mean (± SD) NRS post spray was (S) 0.8 (± 3.1) versus (V) 2.1 (± 2.2) (P< 0.001). There were only 6 minor complaints that all resolved quickly. Four patients felt cool: two (S) patients (2.6% = 2/77) and two (V) patients (2/78 = 2.6%) and two other (V) patients (2/78 = 2.6%) complained of redness.discomfort. Total side effects were (S) 2.6% and (V) 5.2% (4/78). ConclusionVapocoolant is safe and effective in decreasing the pain due to IV cannulation in adults in the ED underging placement of a peripheral IV line with a significant decrease of 2.5 in the NRS compared to saline placebo spray (saline 4.4 NRS versus vapocoolant 1.9 NRS). There were no skin abnormalities noted post spray/post PIV by checklist and by photograph. Vapocoolant is safe and effective in decreasing the pain due to IV cannulation in adults in the ED underging placement of a peripheral IV line with a significant decrease of 2.5 in the NRS compared to saline placebo spray (saline 4.4 NRS versus vapocoolant 1.9 NRS). There were no skin abnormalities noted post spray/post PIV by checklist and by photograph.
When anesthesia/procedural sedation is administered for elective procedures, patients are NPO for > 8-hours in order to limit complications based on recommendations from anesthesiology. Should this 8 hour rule be applied to emergency department (ED) patients? ED patients in need of procedural sedation such as relocation of a displaced fracture often have recently eaten and are not usually NPO for 8 hours when they arrive in the ED. Should we make patients in the ED wait up to this 8-hour rule or should we proceed without meeting this requisite 8-hour time frame.
Patients with various dysrhythmias may undergo electrical cardioversion (CV). Historically, CV has been done by cardiologists, often on inpatients and electively. Patients who present to the emergency department (ED) may need CV on an emergent basis requiring procedural sedation. Some have recommended that CV be done only by cardiologists in a cardiology procedural suite. The study objective was to evaluate a series of CV done by emergency physicians in the ED. We hypothesize that CV can be done safely and effectively by emergency physicians even in critically ill patients. This was a retrospective analysis of a prospective procedural sedation registry of ED patients undergoing CV in a large, urban, tertiary care hospital ED. Spearman correlation coefficients were calculated using SPSS statistical software package. Of the 507 patients requiring CVs with procedural sedation in the ED, the mean age (± SD), was 59.0 years (± 16.4), 60.7% male, 50.6% adult (21-64 years), 40.8% geriatric ≥ 65 years. 71.4% were ASA class 3 or 4 with 46.5% being ASA Class 3 and 24.9 % being ASA Class 4 or 5. The primary sedatives were etomidate (57.0%) and propofol (25.6%). There were no deaths and no major morbidity related to CV. 87.2% (441/506) of CVs were successful upon first attempt; 26.4% of CV patients experienced an adverse event, which is comparable to that reported for CV done by cardiologists. Complications occurred in 19.9% of CVs. Of these complications 67.9% were systolic BP < 90 mm Hg and 32.1% were respiratory with a respiratory rate < 8 and/or pulse oxygen saturation < 90%. Hypotensive complications were likely due to patients presenting with arrhythmia-related cardiogenic shock. Following CV, the BPs of patients in cardiogenic shock (systolic BP < 90 mm Hg) improved significantly with symptomatic relief (resolution of dyspnea and/or chest pain), although some BPs may have still remained < 90 due to underlying heart disease including heart failure and/or acute MI. Side effects (eg, emesis, coughing) occurred in 6.5%. Incidence of adverse events versus ASA class was statistically significant (P<.001). Incidence of unsuccessful CVs versus ASA class was also statistically significant (P=.015) (Table). CV under procedural sedation can be done safely in the ED, even in critically ill patients (with nearly three-fourths of patients ASA class ≥ 3) and has a very high success rate.TableSide effects,+ Complications = Adverse events versus ASAASA ClassSide EffectsComplicationsAdverse Events1-26.9% (10/144)6.3% (9/144)13.2% (19/144)35.5% (13/237)20.7% (49/237)26.2% (62/237)4-57.9% (10/126)34.1% (43/126)42.1% (53/126)P value.7208<.0001<.0001Total6.5% (33/507)19.9% (101/507)26.4% (134/507) Open table in a new tab
To evaluate the association between emergency department (ED) length of stay (LOS) for pediatric patients and demographic variables, clinical factors, intensity of service (laboratory tests done, radiology studies done, consults obtained, medications given, IV fluids administered), disposition (admitted or transferred vs. discharged), hospital type (general ED vs. pediatric ED at a Children’s hospital), region of the country and diagnosis, especially psychiatric diagnosis. Prospective, multicenter, observational, cohort study of all pediatric ED patients seen in 6 hospitals on 1 day. The 6 hospitals included were from all regions of the country and included different types of EDs including general hospitals where both adults and children are seen and pediatric EDs at children’s hospitals. All pediatric (age≤ 21 years) patients in the ED on the given day. LOS as a function of patient (demographic, clinical, diagnosis, disposition), intensity of service (tests, consults, medicines given, IV fluids administered), and ED/hospital variables were evaluated. Statistical analyses included Kruskal-Wallis and Wilcoxon rank sum tests There were 641 patients from 6 sites. Psychiatric patients median LOS 5 hours [P25=3.8, P75=10.3]) was significantly higher (p<0.001) than nonpsychiatric patients (median 2.7 [P25=2, P75=3.7]). Median LOS (hours) was a low of 2.3 dermatologic or musculoskeletal- trauma to high of 5 (psychiatric), next highest major medical (eg, diabetes, sickle cell) 4.2 then gastrointestinal 3.6 and fever 3.5. Comparison of psychiatric with nonpsychiatric patients revealed: lab test 24.3% vs. 57.1% (p= .01), any radiology study 37.74% vs. 7.1% (p= 0.04), consult requested 14% vs.84.6% (p< 0.001), admit or transfer 35.7% vs. 10.6% (p =0.015) received medication 58.3% vs. 28.6% (p= 0.051). No significant difference existed between psychiatric and nonpsychiatric patients for sex, ethnicity, arrival mode, or insurance status. 8% of all patients, 7.2% of nonpsychiatric, 42.9% psychiatric patients have a LOS > 6 hours. Sex, ethnicity, insurance status, and mode of arrival had no significant effect on LOS. Testing, consultations and diagnosis especially psychiatric diagnosis did significantly increase LOS. These correlations persisted no matter what the type of ED (children’s hospital or general ED) or the region of the country. Psychiatric patients were more likely to be older, have a laboratory test, and have a consult but less likely to have any radiology study. Even adjusting for these variables, psychiatric patients still have a significantly longer LOS (p< 0.001). Pediatric ED LOS is highly variable. LOS is increased if testing is done, consults obtained, if patients are admitted/transferred and by diagnostic category, with psychiatric patients having the longest LOS.
Background: It is important to assess factors contributing to ED length of stay (LOS), a key marker of emergency department (ED) throughput.Study Objectives: To evaluate whether various factors are associated with LOS; namely, patient disposition, number of lab tests, age group, type of ED, receiving a patient consult, and receiving a radiology study.Methods: A prospective, observational, multisite cohort study of a 24-hour consecutive sample of pediatric ED patients was conducted on 11/14/11 at 6 U.S. EDs: 3 children's hospitals, 3 general EDs of which 2 had separate pediatric areas, and 1 integrated adult and pediatric area.Demographic information was collected.A mixed models approach was used to model total LOS as a function of disposition (admitted or discharged), number of lab tests (none, 1 -2, > 3), age group (< 28 days, 1 month -<2 years, 2 -<5 years, 5 -<13 years, 13 -21 years), type of ED (General ED, Children's ED), receiving a patient consult (yes, no) and receiving a radiology study (yes, no).Results: A total of 641 pediatric patients were screened, with a final sample size of 628 eligible patients (6 with unknown admission/discharge status; 6 transferred, 1 with disposition decision time before admission); 67 admitted and 561 discharged.Ages ranged from 0-21 years, with a mean age of 7.54 (AE 6.12).Subjects were Caucasian (36.81%),African American (25.28%),Hispanic (22.75%),Asian (3.48%) and other/ unknown (11.58%); and 52.35% male.Most subjects arrived by private vehicle (91.63%), basic life support (5.53%) and advanced life support ambulances (2.21%).Total LOS was significantly associated with number of lab tests (P < 0.0001), patient consults (P < 0.0002) and radiology study (P < 0.0001).The effects of disposition (P < 0.0546), age group (P < 0.2051) and type of ED (P < 0.4382) were not significant.Subjects with at least one lab test had a significantly longer LOS as compared to those with no lab tests.Subjects with 1 -2 lab tests (mean 227.93 minutes, standard error (SE): 29.00) and > 3 lab tests (mean 312.61 min, SE: 29.28) stayed, on average, 23 and 107 minutes longer than subjects with no lab tests (mean 205.14 min, SE: 28.48), respectively.Subjects with a patient consult (mean 268.94 min, SE: 29.10) stayed, on average, 41 minutes longer than subjects with no patient consult (mean 228.18 min, SE: 28.19).Subjects with a radiology study (mean 270.26 min, SE: 28.39) stayed, on average, 43 minutes longer than subjects with no radiology study (mean 226.86 min, SE: 28.40).Conclusions: Patients stayed in the ED longer when they received a patient consult, radiology study, or at least one lab test, than those who did not.Focusing on addressing factors contributing to increased LOS may help improve overall patient satisfaction and care.
Length of stay (LOS) is a key marker of emergency department (ED) throughput. To describe ED LOS and various throughput metrics in admitted and discharged pediatric patients. A prospective, observational, multisite cohort study, 24-hour consecutive sample of pediatric ED patients was conducted on 11/14/11 at 6 U.S. EDs: 3 children's hospitals, 3 general EDs (2 had separate pediatric areas, and 1 integrated adult/pediatric). Demographic information and time intervals were collected. Primary outcome variables were total LOS and time interval from door to provider and disposition decision to departure. Descriptive statistics (median, first quartile (Q1) (25th percentile), third quartile (Q3) (75th percentile)) were used for time intervals overall and by disposition. A mixed model was also used to compare the mean time from disposition decision to departure. A total of 641 pediatric patients were screened, with 628 eligible patients (6 unknown admission/discharge status; 6 transferred, 1 disposition decision time before admission); 67 admitted and 561 discharged. Ages ranged from 0-21 years, mean age 7.54 (± 6.12). Subjects were Caucasian (36.81%), African-American (25.28%), Hispanic (22.75%), Asian (3.48%) and other/unknown (11.58%); and 52.35% male. Most subjects arrived by private vehicle (91.63%), Basic Life Support (5.53%) and Advanced Life Support ambulances (2.21%). Overall, the median total LOS was 163 minutes (min) (Q1 = 117, Q3 = 226). Admitted patients had a longer total LOS (median = 239 min, Q1 = 181, Q3 = 341) than discharged patients (median = 157 min, Q1 = 113, Q3 = 217). Overall, the median time from door to provider was 51 min (Q1 = 21, Q3 = 88). Discharged patients had a longer wait time from door to provider (median = 56 min, Q1 = 22, Q3 = 90) than admitted patients (median = 29 min, Q1 = 13, Q3 = 54.5) The median and mean time from admission decision to ED departure among admitted patients was 76.5 min (Q1 = 53, Q3 = 112.5) and 80.36 min (SE: 8.94) respectively (information was only available for 36 of the 67). The median and mean from discharge decision to departure was 14 min (Q1 = 9, Q3 = 23) and 10.66 (SE: 7.98), respectively for discharged patients. Admitted subjects waited, on average, 70 minutes longer from disposition decision to departure as compared to discharged (P < 0.0001). Admitted patients had a longer total LOS than discharged patients. Discharged patients had a longer wait time from door to provider as compared to admitted patients. Focusing on ways to improve the time from door to provider for lower acuity patients as well as final departure from the ED may improve overall ED LOS and patient satisfaction.
Study Objectives: Pain is the most common chief complaint for patients seeking care in the emergency department (ED). Up to 70% of ED visits are related to pain as the rationale for the ED visit. Ketorolac is effective in relieving pain, is nonaddicting, avoids many opioid side effects including respiratory depression, hypotension, constipation, nausea, and vomiting. Compared with starting an intravenous (IV) line, intranasal (IN) drug administration is less painful, faster (starting an IV takes time) which allows for earlier onset of drug administration and earlier onset of pain relief), easier to administer, and with a lesser cost than IV (since it takes less ED staff time to administer). It is also less painful than the intramuscular (IM) route. IN has a much quicker onset and less variable absorption than the oral (po) route. Although the use of ketorolac via the IV/IM/po routes is well established, IN ketorlac use has not been well studied. This study determined if IN ketorolac is effective and safe in ED patients with acute pain. Methods: A prospective, open label efficacy, safety and feasibility trial of IN ketorolac in adults (18 -64 years) with acute pain in the ED of a large urban tertiary care referral hospital. Numeric rating scales (NRS) (1 to 10) were obtained before and after the IN ketorolac (Luitpold sprix ®). Side effects were documented. The nasal mucosa was examined and vital signs done before and after the IN ketorolac spray (IK) was given. Side effects were documented. Results: Twenty-six adults were evaluated. Mean age was 37.2 (± SD 11.5) yrs, 42.3% males, 73.1% African-American, 23.1% white , 3.8% Hispanic. Chief complaints were chest pain (CP) (N= 7), back pain (N=5), flank pain (N=5), extremity pain (N=3), abdominal pain (N=2), head pain (N=2), groin pain (N=1), sore throat (N=1). Final diagnoses were musculoskeletal (MS) CP (N=7), kidney stone (N= 4), UTI (N=1), MS back pain (N=5), MS extremity pain (N=3), dysmenorrhea (N=2), MS groin pain (N=1), pharyngitis (N=1), scalp boil (N=1), MS head/neck pain (N=1). There were 4 side effects (4/26, 15.4%) which consisted of watery eyes/throat burning (N=1), throat irritation/dry heaves (N=1), bad taste in mouth (N=1), and burning in nose (N=1); all resolved within minutes after drug administration. Post IN ketorolac, the nasal mucosa appeared normal. Mean NRS pre IN ketorolac was 7.6 (SD ±1.6) (range 4 to 10), post IN ketorolac 2.2 (SD ± 2.0) (range 0 to 6) which was significant at p= 0.02. The mean decrease in NRS (pre IN ketorolac baseline NRS - post IN ketorolac lowest NRS) = 4.7 (SD±2.0). Conclusion: Intranasal ketorolac is effective and safe for the treatment of acute pain in ED patients with a variety of different chief complaints and diagnoses and was well tolerated with a few minor side effects. Nasopharyngeal burning/irritation is the most common side effect, occurring in 7.7% of patients. The administration of IN ketorlac was well tolerated with no visible abnormalities of the nasal mucosa following IN ketorolac.
Study Objective: This study aims to evaluate if there is a correlation between the age of the child and the number of laboratory tests performed in the emergency department (ED). Studying patterns of laboratory testing on pediatric patients may help better understand factors influencing length of stay (LOS), since laboratory testing has been shown to extend ED LOS. Methods: A prospective, observational, 24-hour consecutive sample study of pediatric emergency medicine patients was conducted on November 14, 2011 at 6 U.S. emergency departments. Data was collected at 3 children's hospitals with pediatric EDs, 2 hospitals with separate pediatric areas within their EDs, and one hospital with an integrated ED that sees both adult and pediatric patients in the same area. Demographic information, mode of arrival and insurance information were collected. The frequency of main laboratory and point-of-care testing (POCT) testing was assessed. If subjects had the same test done in both the main laboratory and POCT, the test was only counted once. The relationship between subject's age and the number of tests was examined using Spearman's correlation coefficient. Results: A total of 643 subjects were enrolled. The ages ranged from 0-21 years; the mean age was 7.54 (± 6.12). The sample was 52.35% male. The subjects were white (36.81%), African-American (25.28%), Hispanic (22.75%), Asian (3.48%) and other/unknown (11.58%). Most subjects arrived by private vehicle (91.63%). Other modes of arrival included advanced life support ambulances (2.21%) and basic life support ambulances (5.53%). Managed care insurance (43.23%) was the most common payment option; other options included private insurance (26.75%), Medicaid (32.97%), self-pay (5.29%) and military insurance (3.27%). The number of laboratory tests ranged from 0-15 per subject; the majority of subjects had no laboratory tests (66.87%). There were 22 subjects with the same test conducted in the main laboratory and POCT. These tests included urinalysis, D-dimer, pregnancy test (urine), rapid strep test and “other” lab tests. There was a significant correlation between the number of laboratory tests and age (ρ = 0.2314, P < 0.0001). As age increased, the number of laboratory tests increased. Conversely, as age decreased, the number lab tests decreased. Conclusion: In the ED, older children had more laboratory tests performed than younger children. These results suggest the need for future research to look at how acuity and chief complaint may also impact the frequency of testing as well as LOS.
Study ObjectivesGeriatric patients have been found to be a high risk group of patients in various settings. For example, geriatric trauma patients have a significantly higher morbidity and mortality than non-geriatric adult patients. This is also true for elderly patients presenting to the emergency department (ED) with undifferentiated abdominal pain and those with cardiac disease. Procedural sedation is commonly performed in the ED for various procedures including fracture reduction, cardioversion, reduction of dislocated joints, foreign body removal, and wound care. Whether geriatric patients are at a higher risk for ED procedural sedation is unknown. The objective of this study was to evaluate ED procedural sedation including adverse events with comparisons based on age, focusing on the geriatric patient.MethodsThis was a prospective data collection on a standardized hospital-wide quality improvement (QI) form of all patients (pediatric and adult) undergoing procedural sedation in the ED over 10 years. Pediatric patients were age ≤ 21 years, adults were ≥ 22 years of age and geriatric patients were ≥ 65 years of age. Geriatric patients were further subdivided into “younger” geriatric (65 to 79 years of age) and “older” geriatric patients (age 80 years and above). The setting was the ED of a academic, urban, tertiary-care hospital.ResultsThere were 2460 procedural sedations done over ten years in ED patients from 2 weeks of age to 102 years with 45% female, 55% male. There were 857 chidren and infants and 1603 adults, with 940 non-geriatric adults, and 663 geriatric adults. There were 476 “younger” geriatric (65 to 79 years) and 187 “older” geriatric patients (age 80 years and above). The most common adverse events were hypotension, oxygen saturation < 90%, bradynpea/apnea, dysrhythmia, hypertension, and allergic reactions. The incidence of adverse events were pediatric patients 4.6%, nongeriatric adults 18.2%, geriatric adults 24.0%, younger geriatric patients 21.6% vs. older geriatric patients 31%. The results between the 3 age groups and between the younger and older geriatric patients were all highly significant (p<0.01). Older patients tended to have higher American Society of Anesthesia (ASA) classes but these age differences remained irrespective of other parameters including the ASA class, procedure being done, and sedative used. Multivariate analysis confirmed that the significant differences based on age (pediatric vs. nongeriatric adult vs. geriatric) and within the elderly (eg, younger vs. older geriatric patients) remained irrespective of other variables.ConclusionThe elderly represent a high-risk group of patients undergoing procedural sedation in the ED even when other factors such as ASA class, sedative used and procedure being done are considered. Furthermore, there are also important differencs within the geriatric population with a significantly greater incidence of adverse events occurring in the “older” geriatric patient (age ≥ 80 years) compared to the “younger” geriatric patient (age < 80 years). Study ObjectivesGeriatric patients have been found to be a high risk group of patients in various settings. For example, geriatric trauma patients have a significantly higher morbidity and mortality than non-geriatric adult patients. This is also true for elderly patients presenting to the emergency department (ED) with undifferentiated abdominal pain and those with cardiac disease. Procedural sedation is commonly performed in the ED for various procedures including fracture reduction, cardioversion, reduction of dislocated joints, foreign body removal, and wound care. Whether geriatric patients are at a higher risk for ED procedural sedation is unknown. The objective of this study was to evaluate ED procedural sedation including adverse events with comparisons based on age, focusing on the geriatric patient. Geriatric patients have been found to be a high risk group of patients in various settings. For example, geriatric trauma patients have a significantly higher morbidity and mortality than non-geriatric adult patients. This is also true for elderly patients presenting to the emergency department (ED) with undifferentiated abdominal pain and those with cardiac disease. Procedural sedation is commonly performed in the ED for various procedures including fracture reduction, cardioversion, reduction of dislocated joints, foreign body removal, and wound care. Whether geriatric patients are at a higher risk for ED procedural sedation is unknown. The objective of this study was to evaluate ED procedural sedation including adverse events with comparisons based on age, focusing on the geriatric patient. MethodsThis was a prospective data collection on a standardized hospital-wide quality improvement (QI) form of all patients (pediatric and adult) undergoing procedural sedation in the ED over 10 years. Pediatric patients were age ≤ 21 years, adults were ≥ 22 years of age and geriatric patients were ≥ 65 years of age. Geriatric patients were further subdivided into “younger” geriatric (65 to 79 years of age) and “older” geriatric patients (age 80 years and above). The setting was the ED of a academic, urban, tertiary-care hospital. This was a prospective data collection on a standardized hospital-wide quality improvement (QI) form of all patients (pediatric and adult) undergoing procedural sedation in the ED over 10 years. Pediatric patients were age ≤ 21 years, adults were ≥ 22 years of age and geriatric patients were ≥ 65 years of age. Geriatric patients were further subdivided into “younger” geriatric (65 to 79 years of age) and “older” geriatric patients (age 80 years and above). The setting was the ED of a academic, urban, tertiary-care hospital. ResultsThere were 2460 procedural sedations done over ten years in ED patients from 2 weeks of age to 102 years with 45% female, 55% male. There were 857 chidren and infants and 1603 adults, with 940 non-geriatric adults, and 663 geriatric adults. There were 476 “younger” geriatric (65 to 79 years) and 187 “older” geriatric patients (age 80 years and above). The most common adverse events were hypotension, oxygen saturation < 90%, bradynpea/apnea, dysrhythmia, hypertension, and allergic reactions. The incidence of adverse events were pediatric patients 4.6%, nongeriatric adults 18.2%, geriatric adults 24.0%, younger geriatric patients 21.6% vs. older geriatric patients 31%. The results between the 3 age groups and between the younger and older geriatric patients were all highly significant (p<0.01). Older patients tended to have higher American Society of Anesthesia (ASA) classes but these age differences remained irrespective of other parameters including the ASA class, procedure being done, and sedative used. Multivariate analysis confirmed that the significant differences based on age (pediatric vs. nongeriatric adult vs. geriatric) and within the elderly (eg, younger vs. older geriatric patients) remained irrespective of other variables. There were 2460 procedural sedations done over ten years in ED patients from 2 weeks of age to 102 years with 45% female, 55% male. There were 857 chidren and infants and 1603 adults, with 940 non-geriatric adults, and 663 geriatric adults. There were 476 “younger” geriatric (65 to 79 years) and 187 “older” geriatric patients (age 80 years and above). The most common adverse events were hypotension, oxygen saturation < 90%, bradynpea/apnea, dysrhythmia, hypertension, and allergic reactions. The incidence of adverse events were pediatric patients 4.6%, nongeriatric adults 18.2%, geriatric adults 24.0%, younger geriatric patients 21.6% vs. older geriatric patients 31%. The results between the 3 age groups and between the younger and older geriatric patients were all highly significant (p<0.01). Older patients tended to have higher American Society of Anesthesia (ASA) classes but these age differences remained irrespective of other parameters including the ASA class, procedure being done, and sedative used. Multivariate analysis confirmed that the significant differences based on age (pediatric vs. nongeriatric adult vs. geriatric) and within the elderly (eg, younger vs. older geriatric patients) remained irrespective of other variables. ConclusionThe elderly represent a high-risk group of patients undergoing procedural sedation in the ED even when other factors such as ASA class, sedative used and procedure being done are considered. Furthermore, there are also important differencs within the geriatric population with a significantly greater incidence of adverse events occurring in the “older” geriatric patient (age ≥ 80 years) compared to the “younger” geriatric patient (age < 80 years). The elderly represent a high-risk group of patients undergoing procedural sedation in the ED even when other factors such as ASA class, sedative used and procedure being done are considered. Furthermore, there are also important differencs within the geriatric population with a significantly greater incidence of adverse events occurring in the “older” geriatric patient (age ≥ 80 years) compared to the “younger” geriatric patient (age < 80 years).
Establishing intravenous (IV) access can be difficult in dehydrated children, who often have small, volume-depleted veins. Hyaluronidase-facilitated subcutaneous (HFSC) rehydration therapy with recombinant human hyaluronidase (rHuPH20) represents an alternative to IV in children with mild to moderate dehydration. A previously published multicenter, open-label, single-arm study (N=51) provided safety, efficacy, and tolerability data on HFSC rehydration therapy with rHuPH20 in children with mild to moderate dehydration. The objective of the INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration II (INFUSE-Peds II) study was to evaluate whether in a pediatric population with mild to moderate dehydration, HFSC fluid administration with rHuPH20 can be given safely and effectively in clinically-appropriate volumes, no less than that delivered via IV administration. Children aged 1 month to 10 years presenting to emergency departments with mild to moderate dehydration were enrolled in a Phase IV, multicenter, randomized, open-label, noninferiority, company-sponsored clinical trial. Patients were stratified by baseline dehydration severity and body weight and randomized to receive 20 mL/kg isotonic fluid via HFSC or IV over 1 hour and additional fluid, as needed, until clinically rehydrated for up to 72 hours. The primary outcome was total fluid volume administered at a single infusion site; secondary outcomes included dehydration symptoms, Gorelick dehydration score, ease of use measures, and safety evaluations. Enrollment (November 2008 to December 2009, 24 sites, N=148) is complete. Interim analysis is reported on 74 patients (37 HFSC, 37 IV), mean (SD) age 1.98 (1.56) years. Mean (SD) volume infused was 374 (292.1) mL HFSC versus 491 (645.3) mL IV. Mean (SD) duration of infusion at a single site was 2.8 (3.29) hours HFSC versus 6.0 (13.75) hours IV. When analysis of covariance was performed to adjust for duration of infusion, mean volume infused was 445 mL HFSC versus 419 mL IV. Mean improvement in dehydration score (95% CI) was −2.8 (−3.2, −2.4) HFSC and −2.4 (−3.0, −1.8) IV; mean weight change did not differ between groups. Initial catheter placement was successful in 97% HFSC versus 49% IV (OR=38.0; 4.7-306.9); median placement time (95% CI) was 0.6 minutes (0.25, 0.92) HFSC versus 5.0 minutes (1.0, 9.92) IV. Crossover for rescue treatment occurred in 0/37 HFSC versus 8/37 IV patients. Adverse events were mild to moderate in severity: pain (73% HFSC, 86% IV), erythema (73% HFSC, 6.9% IV), swelling (80% HFSC, 0% IV), and extravasation (0% HFSC, 3% IV). In this interim analysis duration-adjusted mean fluid volume and resolution of dehydration signs and symptoms were comparable for the HFSC and IV routes, catheter placement took less time and was more often successful on the first attempt with HFSC versus IV, and HFSC infusions with rHuPH20 were generally well tolerated. These data suggest that the HFSC route represents a useful alternative to IV for isotonic fluid administration in this patient population. Final analysis of the complete data to be presented at the American College of Emergency Physicians' 2010 Research Forum will provide more definitive results from this trial.
Study Objectives: The Increased Flow Utilizing Subcutaneously Enabled Pediatric Rehydration Study II (INFUSE II) evaluates whether recombinant human hyaluronidase (rHuPH20)-facilitated subcutaneous (SC) fluids are safe and effective in volumes no less than delivered via the intravenous (i.v.) route in mildly to moderately dehydrated infants and children. Methods: In this ongoing phase-4, open-label, randomized, stratified study, patients are children aged 1 month to < 3 years in emergency or pediatric inpatient departments with mild to moderate dehydration. Stratified based on body weight and dehydration severity, patients are randomly assigned to rehydration therapy (20 mL/kg isotonic fluid over 1 h and additional fluid as needed until deemed clinically rehydrated up to 72 h) via rHuPH20-facilitated SC or i.v. One mL rHuPH20 (150 U) is administered SC followed by SC isotonic fluids. Total fluid volume administered at a single infusion site is the primary study endpoint. Secondary endpoints include percentage successfully hydrated, time to urine output, total volume infused, and safety and health care provider ease-of-use assessments. Results: Interim data analysis was conducted on 41 patients (20 SC; 21 i.v.); mean age 1.6 years. Baseline Gorelick score indicated mild dehydration in 45% vs. 71%, and moderate in 55% vs. 29% in SC vs. i.v. groups, respectively. The primary efficacy outcome—mean total volume (standard deviation [SD]) infused at a single site—was 329 (216.7) mL SC vs. 560 (799.4) mL i.v. (Table 1). Least squares mean (LSM) (SD) for total volume infused, adjusted for infusion duration, was 466 (176.1) mL SC vs. 429 (175.9) mL i.v. Mean volume/body weight (SD) was 28 (17.2) mL/kg SC vs. 52 (77.2) mL/kg i.v.; LSM (SD), adjusted for infusion duration, was 42 (11.9) mL/kg SC vs. 39 (11.9) mL/kg i.v. Table 2 summarizes secondary endpoint results. Conclusions: Interim results suggest rHuPH20-facilitated SC infusion is safe and effective; duration-adjusted mean fluid volume infused was comparable for both routes, and a higher percentage of patients were successfully rehydrated via SC vs. i.v.