Corrie E. Chumpitazi

A multicenter randomized controlled trial of intravenous magnesium for sickle cell pain crisis in children

Magnesium, a vasodilator, anti-inflammatory, and pain reliever, could alter the pathophysiology of sickle cell pain crises. We hypothesized that intravenous magnesium would shorten length of stay, decrease opioid use, and improve health-related quality of life (HRQL) for pediatric patients hospitalized with sickle cell pain crises. The Magnesium for Children in Crisis (MAGiC) study was a randomized, double-blind, placebo-controlled trial of intravenous magnesium vs normal saline placebo conducted at 8 sites within the Pediatric Emergency Care Applied Research Network (PECARN). Children 4 to 21 years old with hemoglobin SS or Sβ(0) thalassemia requiring hospitalization for pain were eligible. Children received 40 mg/kg of magnesium or placebo every 8 hours for up to 6 doses plus standard therapy. The primary outcome was length of stay in hours from the time of first study drug infusion, compared using a Van Elteren test. Secondary outcomes included opioid use and HRQL. Of 208 children enrolled, 204 received the study drug (101 magnesium, 103 placebo). Between-group demographics and prerandomization treatment were similar. The median interquartile range (IQR) length of stay was 56.0 (27.0-109.0) hours for magnesium vs 47.0 (24.0-99.0) hours for placebo (P = .24). Magnesium patients received 1.46 mg/kg morphine equivalents vs 1.28 mg/kg for placebo (P = .12). Changes in HRQL before discharge and 1 week after discharge were similar (P > .05 for all comparisons). The addition of intravenous magnesium did not shorten length of stay, reduce opioid use, or improve quality of life in children hospitalized for sickle cell pain crisis. This trial was registered at www.clinicaltrials.gov as #NCT01197417.

Sedation and anesthesia for CT: emerging issues for providing high-quality care

During the past decades, the use of CT to diagnose conditions and monitor treatment in the pediatric setting has increased. Infants and children often require procedural sedation to maintain a motionless state to ensure high-quality imaging. Various medication regimens have been recommended to achieve satisfactory sedation for this painless procedure. While the incidence of adverse events remains low, procedural sedation carries the risk of serious morbidity and mortality. The use of evidence-based, structured approaches to procedural sedation should be used to reduce variation in clinical practice and improve outcomes.

Intravenous magnesium for pediatric sickle cell vaso‐occlusive crisis: Methodological issues of a randomized controlled trial

Multiple recent Sickle Cell Disease studies have been terminated due to poor enrollment. We developed methods to overcome past barriers and utilized these to study the efficacy and safety of intravenous magnesium for vaso‐occlusive crisis (VOC). We describe the methods of the Intravenous Magnesium in Sickle Vaso‐occlusive Crisis (MAGiC) trial and discuss methods used to overcome past barriers. MAGiC was a multi‐center randomized double‐blind placebo‐controlled trial of intravenous magnesium versus normal saline for treatment of VOC. The study was a collaboration between Pediatric Hematologists and Emergency Physicians in the Pediatric Emergency Care Applied Research Network (PECARN). Eligible patients were randomized within 12 hours of receiving intravenous opioids in the Emergency Department (ED) and administered study medication every 8 hours. The primary outcome was hospital length of stay. Associated plasma studies elucidated magnesiums mechanism of action and the pathophysiology of VOC. Health‐related quality of life was measured. Site‐, protocol‐, and patient‐related barriers from prior studies were identified and addressed. Limited study staff availability, lack of collaboration with the ED, and difficulty obtaining consent were previously identified barriers. Leveraging PECARN resources, forging close collaborations between Sickle Cell Centers and EDs of participating sites, and approaching eligible patients for prior consent helped overcome these barriers. Participation in the PECARN network and establishment of collaborative arrangements between Sickle Cell Centers and their affiliated EDs are major innovative features of the MAGiC study that allowed improved subject capture. These methods could serve as a model for future studies of VOCs. Pediatr Blood Cancer 2014;61:1049–1054.

Procedural Sedation Outside of the Operating Room Using Ketamine in 22,645 Children: A Report From the Pediatric Sedation Research Consortium

Objective: Most studies of ketamine administered to children for procedural sedation are limited to emergency department use. The objective of this study was to describe the practice of ketamine procedural sedation outside of the operating room and identify risk factors for adverse events. Design: Observational cohort review of data prospectively collected from 2007 to 2015 from the multicenter Pediatric Sedation Research Consortium. Setting: Sedation services from academic, community, free-standing children’s hospitals and pediatric wards within general hospitals. Patients: Children from birth to 21 years old or younger. Interventions: None. Measurements and Main Results: Describe patient characteristics, procedure type, and location of administration of ketamine procedural sedation. Analyze sedation-related adverse events and severe adverse events. Identify risk factors for adverse events using multivariable logistic regression. A total of 22,645 sedations performed using ketamine were analyzed. Median age was 60 months (range, < 1 mo to < 22 yr); 72.0% were American Society of Anesthesiologists-Physical Status less than III. The majority of sedations were performed in dedicated sedation or radiology units (64.6%). Anticholinergics, benzodiazepines, or propofol were coadministered in 19.8%, 57.9%, and 35.4%, respectively. The overall adverse event occurrence rate was 7.26% (95% CI, 6.92–7.60%), and the frequency of severe adverse events was 1.77% (95% CI, 1.60–1.94%). Procedures were not completed in 39 of 19,747 patients (0.2%). Three patients experienced cardiac arrest without death, all associated with laryngospasm. Conclusions: This is a description of a large prospectively collected dataset of pediatric ketamine administration predominantly outside of the operating room. The overall incidence of severe adverse events was low. Risk factors associated with increased odds of adverse events were as follows: cardiac and gastrointestinal disease, lower respiratory tract infection, and the coadministration of propofol and anticholinergics.

Impact of emergency department care on outcomes of acute pain events in children with sickle cell disease

The impact of emergency department (ED) treatment on outcomes of sickle cell disease (SCD) acute pain hospitalizations is not well described. We investigated whether length of stay (LOS) and change in health‐related quality of life (HRQL) are affected by initial opioid dose and time to administration. We conducted secondary analyses of data from the randomized‐controlled Magnesium for children in Crisis (MAGiC) trial. The primary outcome was LOS. Secondary outcome was change in HRQL, assessed using PedsQL SCD Pain and Hurt and Pain Impact Domains measured in ED and at discharge. Independent variables were (1) time to first IV opioid, (2) total initial opioid dose (mg/kg/hr of morphine equivalents administered between ED and first study drug), and (3) Time to first oral opioid. Spearman correlations determined the associations with LOS. Using two‐sample t‐tests, we compared mean change in HRQL scores between IV opioid initiated within 60 and >60 min, opioid doses in the highest and lowest tertiles, and oral opioid initiated within 24 and >24 hr. Two hundred and four patients participated at 8 sites. Mean (SD) age was 13.6 (4.7) years. Earlier initiation of oral opioids was strongly correlated with shorter LOS (r = 0.61, P < 0.01). Higher initial opioid dose was weakly correlated with longer LOS (r = 0.34, P < 0.01). Higher initial opioid doses (6 vs −2.2; P = 0.01) and oral opioids initiated within 24 hr (5.7 vs −1.7, P = 0.04) were associated with larger mean change in HRQL at discharge. Prospective trials evaluating the impact of ED care on outcomes of pain hospitalizations could improve SCD pain treatment. Am. J. Hematol. 91:1175–1180, 2016.

Soap Suds Enemas Are Efficacious and Safe for Treating Fecal Impaction in Children With Abdominal Pain.

Objectives: Constipation is a common cause of pediatric abdominal pain and emergency department (ED) presentation. Despite the high prevalence, there is a dearth of clinical information and wide practice variation in childhood constipation management in the ED. The objective of the study was to assess the efficacy and safety of soap suds enema (SSE) in the therapy for fecal impaction in children with abdominal pain within the pediatric ED setting. The primary outcome was stool output following SSE. Secondary outcomes were adverse events, admissions, and return visits within 72 hours. Methods: The present study is a retrospective cross-sectional study performed in the ED at a quaternary care childrens hospital of patients seen during a 12-month period who received an SSE for fecal impaction. Results: Five hundred twelve patients (53% girls, median age 7.8 years, range: 8 months–23 years) received SSE therapy during a 1-year period. Successful therapy (bowel movement) following SSE occurred in 419 (82%). Adverse events included abdominal pain in 24 (5%) and nausea/vomiting in 18 (4%). No SSE-related serious adverse events were identified. Following SSE, 405 (79%) were subsequently discharged, of which 15 (3.7%) returned to the ED for re-evaluation within 72 hours. Conclusions: SSE is an efficacious and safe therapeutic option for the acute treatment of childhood fecal impaction in the ED setting.

A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients

BackgroundOral antipyretics are commonly used to treat pediatric patients who develop fevers. However, patients presenting to the emergency department or undergoing surgery are frequently unable to tolerate oral antipyretics. Rectal formulations are available; however, this route of administration is unpredictable. The main objectives of this randomized controlled study was to evaluate the efficacy and safety of single or multiple doses of intravenous ibuprofen to acetaminophen (oral or suppository) in pediatric patients with fever and to assess plasma ibuprofen concentrations.MethodsThis multi-center study was conducted in hospitalized patients, ≤ 16 years, with a new onset of fever ≥ 38.3°C. Patients were randomly assigned to receive either 10 mg/kg intravenous ibuprofen or acetaminophen. Study drug was administered at hour 0, and thereafter every 4 h as needed, up to 5 days. The primary outcome was to evaluate the effect of a single dose of intravenous ibuprofen compared to acetaminophen in reducing temperature in the first 2 h after administration. Data were compared using an analysis of variance model for continuous measurements and Cochran-Mantel-Haenszel test of general association for categorical data. A two-sided testing was used and a p-value ≤ 0.05 was considered significant.ResultsA total of 103 patients received study medication. Intravenous ibuprofen resulted in a greater reduction in temperature as measured by the area under the change from baseline at 2 h (p = 0.005) and 4 h (<0.001); in a greater reduction in change from baseline temperature compared to treatment with acetaminophen, and it reduced fever throughout a 24 h dosing period. There were no differences in safety parameters or serious adverse events.ConclusionsA single 10 mg/kg dose of intravenous ibuprofen provided a significant reduction of temperature for febrile pediatric patients compared to those that received 10 mg/kg acetaminophen at 2 h and 4 h post-treatment. A reduction in temperature was also demonstrated over 24 h; however the reduction was not considered statically significant. Intravenous ibuprofen provides an effective option for reducing fever in hospitalized pediatric patients.Trial registrationThe study was registered on ClinicalTrials.gov on 26 October 2009, Study Identifier: NCT01002573

Evaluation of opioid prescribing after rescheduling of hydrocodone-containing products

Purpose. Institutional prescribing trends of hydrocodone‐containing products (HCPs) before and after the Drug Enforcement Administrations rescheduling of HCPs were evaluated. Methods. A retrospective evaluation was performed on 6 oral opioid analgesics on the hospital formulary that were prescribed to patients treated at Texas Childrens Hospital and Pavilion for Women for the 6 months before and after the rescheduling of HCPs on October 6, 2014. Patients were eligible for inclusion if they were prescribed any of the following oral agents: HCPs (e.g., hydrocodone with acetaminophen), codeine‐containing products (e.g., codeine, codeine with acetaminophen), morphine, hydromorphone, oxycodone‐containing products (e.g., oxycodone, oxycodone with acetaminophen), and tramadol. Results. During the 12‐month study period, a total of 38,928 inpatient orders and outpatient prescriptions were processed for the studied agents in both locations; the majority were orders for inpatients. An overall reduction in the total number of opioid prescriptions was observed after the rescheduling of HCPs. Substantial increases in the proportional use of codeine were observed in all 4 settings after HCP rescheduling. Data for each of the agents revealed a shift in prescribing patterns centered along the HCP rescheduling date of October 6, 2014, and revealed a decrease in HCP use across all areas with an accompanying increase in codeine‐containing products, oxycodone‐containing products, and tramadol. Conclusion. The rescheduling of HCPs resulted in a reduction in HCP prescriptions but was accompanied by increases in the use of codeine‐containing products and tramadol in all settings.

Diagnostic approach to constipation impacts pediatric emergency department disposition

Objectives: Constipation is a common cause of abdominal pain in children presenting to the emergency department (ED). The objectives of this study were to determine the diagnostic evaluation undertaken for constipation and to assess the association of the evaluation with final ED disposition. Methods: A retrospective chart review of children presenting to the pediatric ED of a quaternary care childrens hospital with abdominal pain that received a soap suds enema therapy. Results: A total of 512 children were included, 270 (52.7%) were female, and the median age was 8.0 (IQR: 4.0–11.0). One hundred and thirty eight patients (27%) had a digital rectal exam (DRE), 120 (22.8%) had bloodwork performed, 218 (43%) had urinalysis obtained, 397 (77.5%) had abdominal radiographs, 120 (23.4%) had abdominal ultrasounds, and 18 (3.5%) had computed tomography scans. Children who had a DRE had a younger median age (6.0, IQR: 3.0–9.25 vs. 8.0, IQR: 4.0–12.0; p < 0.001) and were significantly less likely to have radiologic imaging (OR = 0.50, 95% CI 0.32–0.78; p = 0.002), but did not have an increased odds of being discharged home. After adjusting for gender, ethnicity, and significant past medical history those with an abdominal radiograph were less likely to be discharged to home (aOR = 0.56, 95% CI 0.31–1.01; p = 0.05). Conclusions: The diagnostic evaluation of children diagnosed with fecal impaction in the ED varied. Abdominal imaging may be avoided if children receive a DRE. When children presenting to the ED with abdominal pain had an abdominal radiograph, they were more likely to be admitted.

Creation and Assessment of a Bad News Delivery Simulation Curriculum for Pediatric Emergency Medicine Fellows

Background Bad news in the context of health care has been broadly defined as significant information that negatively alters people’s perceptions of the present or future. Effectively delivering bad news (DBN) in the setting of the emergency department requires excellent communication skills. Evidence shows that bad news is frequently given inadequately. Studies show that trainees need to devote more time to developing this skill through formalized training. This program’s objectives were to utilize trained standardized patients in a simulation setting to assist pediatric emergency medicine (PEM) fellows in the development of effective, sensitive, and compassionate communication with patients and family members when conveying bad news, and to recognize and respond to the patient/parent’s reaction to such news. Methods PEM fellows participated in a novel curriculum utilizing simulated patients (SPs) acting as the patient’s parent and immersive techniques in a realistic and supportive environment. A baseline survey was conducted to ascertain participant demographics and previous experience with simulation and DBN. Experienced, multi-disciplinary faculty participated in a training workshop with the SPs one week prior to course delivery. Three scenarios were developed for bad news delivery. Instructors watched via remote video feed while the fellows individually interacted with the SPs and then participated in a confidential debriefing. Fellows later joined for group debriefing. Fellow characteristics, experience, and self-perceived comfort pre/post-course were collected. Results Baseline data demonstrated that 78% of fellows reported DBN two or more times per month. Ninety-three percent of fellows in this study were present during the delivery of news about the death of a child to a parent or family member in the six-month period preceding this course. Fellows’ self-reported comfort level in DBN to a patient/family and dealing with patient and parent emotions improved significantly (p=0.034 and p=0.046, respectively). Conclusions Pediatric emergency medicine fellows frequently deliver bad news. A course using SPs was well received by trainees and resulted in improvement in self-assessed skills and comfort. This curriculum provides the opportunity for fellows to receive patient/parent feedback of their communication skills and observations from skilled instructors. This methodology should be considered when creating training curricula for bad news delivery skills.