21 Thrombotic Events After Vitamin K Antagonist Reversal With 4-Factor Prothrombin Complex Concentrate or Plasma Milling TJ, Jr , Refaai MA, Goldstein JN, Goldberg-Alberts R, Schneider A, Hug B, Sarode R/University Medical Center at Brackenridge, Dell Children’s Medical Center, Austin, TX; University of Rochester Medical Center, Rochester, NY; Massachusetts General Hospital, Boston, MA; CSL Behring LLC, King of Prussia, PA; CSL Behring GmbH, Marburg, Germany, UT Southwestern Medical Center, Dallas, TX Study Objectives: Patients with major bleeding on vitamin K antagonists (VKA) require rapid reversal by supplementation with vitamin K–dependent factors (VKDFs) and intravenous VK. However, due to underlying risk factors, anticoagulation reversal may place the patient at risk for a thrombotic event (TE). We evaluated TEs after VKA reversal in a randomized trial comparing 4-factor prothrombin complex concentrate (4F-PCC) with plasma in patients with major bleeding. Methods: In this phase IIIb, open-label, noninferiority trial, patients on VKAs presenting with acute major bleeding and INR 2 were randomized to receive plasma and VK or 4F-PCC (containing VKDFs II, VII, IX, X, and proteins C and S) and VK. Laboratory measures included plasma levels of VKDFs at multiple time points. As post-transfusion levels were quite different between the 4F-PCC group and the plasma group, we stratified by treatment arm. The study was performed in accordance with local ethics regulations and written informed consent was obtained from all patients. Results: 103 Patients received 4F-PCC and 109 received plasma. The number (%) of patients with a TE was 8 (7.8) in the 4F-PCC group and 7 (6.4) in the plasma group with a risk difference (95% CI) of 1.3 (6.6 to 9.6). Five patients had 6 serious TEs in the 4F-PCC group on days 9, 10, 13, 29 (same patient as event on day 13), 38, and 43. Four patients had serious TEs in the plasma group on days 1 (2 patients), 13, and 22. A blinded safety adjudication board (SAB) confirmed that serious TEs in 2 patients in each group were possibly treatment related. Resumption of anticoagulation treatment was at the discretion of the treating physician and no patients had resumed VKA therapy at the time of these events despite multiple risk factors for thromboembolism. There were no significant differences in median levels of VKDFs and proteins C and S at 30 minutes after start of infusion in the 4F-PCC or the plasma group in those patients with and without a TE. The majority of patients with TEs (6/8 in 4F-PCC group, 5/7 in plasma group) were >70 years old (mean 75; range 54-89), compared with a mean age of 70 years (range 26-96) in the overall study population. Six patients in the 4F-PCC group and 3 in the plasma group had events consistent with the original indication for anticoagulation. There were 4 myocardial events (ischemia [2], infarction [2]) in the plasma group, 3 on day 1 and 1 on day 13, while there was only 1 myocardial infarction event (unconfirmed by the SAB) in the 4F-PCC group, on day 38. There were 2 deaths in the 4F-PCC group in patients with a TE, 1 from sepsis (66- year-old patient with device clot, day 25) and 1 from the assumed myocardial infarction at day 38 (88-year-old patient, with significant underlying risk factors, treated for gastrointestinal bleed discharged without VKA). There were no deaths in the plasma group in patients with a TE. Conclusions: The incidence of TEs following VKA reversal with 4F-PCC or plasma was similar and was independent of post-therapy factor levels. Events typically occurred earlier in the plasma group (days 1-22) than in the 4F-PCC group (days 9-43) in patients >70 years of age. No VKA therapy was reinitiated before TEs in all of these patients. A guideline regarding restart of anticoagulation treatment in such high-risk patients is warranted. At abstract submission, the final product labeling for this 4F-PCC (Kcentra) had not been approved by the FDA. 22 Safety of Intranasal Midazolam: An Analysis of Adverse Events in a Multicenter Cohort Mellion S, Wathen J, Brent A, Adelgais K/Children’s Hospital Colorado/University of Colorado School of Medicine, Aurora, CO Study Objectives: Midazolam is used as a sedative agent for a variety of procedures across institutions. The intranasal (IN) route allows for adequate levels of sedation without the need for parenteral administration. To date, minimal descriptive data are available regarding safety of IN midazolam due to limitations in sample size. Our aim is to describe the utilization of IN midazolam within a multicenter cohort and to characterize adverse events. Methods: This is a secondary analysis of the data set maintained by the Pediatric Sedation Research Consortium (a multicenter consortium of hospitals prospectively collecting data on all pediatric sedation procedures). We analyzed all patients 0 to 18 years old entered into the database from January 2000 to December 2010 who received IN midazolam. Adverse events were defined as respiratory compromise (apnea, airway obstruction, prolonged desaturations, need for airway support), agitation, administration of a reversal medication, vomiting, inadequate sedation, allergic reaction, and cardiac arrest. We examined patient demographic factors, including age, NPO status, type of procedure, location of sedation, and provider type. Univariate analysis was performed to identify factors associated with an adverse event. Results: Of the 4,324 patients who received IN midazolam, 1,983 (44.8%) received IN midazolam in isolation. Median age was 24 months old, 57.8% were male, median NPO time was 5 hours for solids and/or liquids, and median ASA status was 2. The median dose administered was 0.29 mg/kg. The majority (>80%) of patients were cared for by 1 of 3 provider types: pediatric anesthesiologist (48.3%), pediatric intensivists (21.4%), and pediatric emergency medicine physicians (9.4%). The most common site of procedures was sedation units (68.3%, 1,355/1,983), followed by radiology departments (43.1%, 855/1,983). Most patients (73%, 1,447/1,983) underwent radiologic procedures and/or diagnostic imaging. Adverse events occurred in 4.6% (92/1,983) of patients. Among those patients, airway obstruction was the most common respiratory complication (21.7%, 20/92), followed by cough (6.5%, 6/92). Prolonged desaturation (>30 seconds) occurred in 12% (11/92) of patients and a total of 13 patients (14.1%) required airway support with bag-valve-mask ventilation. No deaths were reported; no patients were intubated, received reversal medications, had an allergic reaction, or had a cardiac event. Agitation was the most common nonrespiratory adverse event (8.7%, 8/92) and a total of 6 patients had inadequate sedation. There were no differences in adverse events based on median age, midazolam dose, NPO status, or ASA classification. Complication rates by provider type were 1.3%, 6.6%, and 8.5% with pediatric anesthesiologists, pediatric emergency medicine physicians, and pediatric intensivists, respectively (P<.05). Conclusions: Adverse events for patients who receive IN midazolam in a multicenter cohort are rare. Complications do not appear to be impacted by demographics, including median ASA and NPO time. Comparison by provider type requires further evaluation. Based on these findings, IN midazolam may be an ideal option for sedation across institutions. 23 Multicenter Analysis of Factors Associated With Delayed Analgesia and Response to Pain Medication in Pediatric Renal Colic Patients Lema PC, Radeos M, Kovach C, Corujo O, Ali Z, Franklin J, Ladkany D, Lester Terrence, Romney M, Datta AR/University of Rochester Medical Center, Rochester, NY; New York Hospital Queens, Flushing, NY Background: Adequate analgesia is an important quality measure in the emergency department (ED). Inadequate analgesia among pediatric patients with acute pain has been extensively studied in previous studies. Pediatric patients frequently receive inadequate analgesia. Recently, an increase in the incidence of urolithiasis among pediatric patients has been noted. Adequate analgesia of pediatric patients with renal colic has not been widely studied. Study Objectives: The purpose of this study was to assess if patient age, sex, and type of analgesia affect adequate analgesia among pediatric patients who present to the ED with renal colic. We reviewed patient demographics, degree of pain, and time and type of analgesia administered. Methods: This was a multicenter retrospective analysis of medical records of patients 21 years of age diagnosed with renal colic at 2 regional Level I trauma centers with a pediatric emergency department, each with >27,000 annual visits. Records were identified with a search for specific terms within the chief complaint and final diagnosis. A search of key words (renal colic, ureterolithiasis, flank pain, kidney stone, nephrolithiasis, abdominal pain, and hematuria) was performed. All patients with a positive diagnosis of ureterolithiasis by an objective test such as computed tomography (CT), radiograph, ultrasound, or urinalysis with hematuria were enrolled. Based on previous analgesia studies, patients were categorized into 3 age groups: 15 years old (yo), 16-18 yo, and 19 yo. We dichotomized our outcome, delayed time to analgesia (TTA), as greater than 1 hour. Univariate statistics were presented as chi-squared or Fisher exact test, as appropriate. By convention, we used an alpha of .05 and odds ratios (OR) with 95% confidence intervals (CIs). We created a stepwise logistic regression to determine factors associated with delayed TTA. Results: A total of 200 patients from both institutions from March 2011 through December 2012 with a diagnosis of nephrolithiasis were identified. Patient ages ranged Research Forum Abstracts S10 Annals of Emergency Medicine Volume 62, no. 4s : October 2013