Wisconsin — Targeted Issue

Description

The CHaMP Research Node held an EMS Grant Workshop in which investigators were able to meet with federal representatives to gain feedback on their ideas and learn about pathways to obtaining funding. The goal was to give researchers focused on pediatric EMS an understanding of the NIH process and insight on how to turn their concepts into federally funded research. Below is a list of the lectures that were provided and their key messages, along with links to available lecture slides.

Author(s)/Presenter(s)

Jonathan R Studnek, Lorin R Browne, Manish I Shah, Nicole Fumo, Matthew Hansen, E Brooke Lerner

Abstract/Description

Introduction: The pediatric early warning score (PEWS) and the bedside pediatric early warning score (BPEWS) are validated tools that help determine the need for critical care in children with acute medical conditions. These tools could be used by EMS and have not been evaluated outside of the hospital. This study retrospectively tested the validity of these tools in the prehospital setting to identify children who needed a hospital with higher level pediatric resources. Methods: This was a multi-center retrospective validation of screening tools using prehospital and in-hospital data obtained from 3 EMS agencies. EMS patient records from April 1, 2013 to April 30, 2015 were used to identify subjects for this analysis. Pediatric patients were retrospectively classified using the PEWS based on the clinical information documented in the EMS medical record. Those with PEWS scores greater than 4 were matched to a subject with scores less than 4 based on age, gender, and paramedic primary impression. Hospital medical record review was then used to determine whether the patient required a hospital with higher level pediatric resources. These classifications were used to calculate sensitivity, specificity, and resultant 95% confidence intervals. The analysis was repeated for included subjects who had sufficient data to calculate BPEWS. Results: There were 386 patients enrolled. A PEWS ≥ 4 demonstrated a sensitivity of 62.8 (95% CI 53.6-71.4) and a specificity of 55.9 (95% CI 49.6-61.9) in identifying a patient who required a hospital with higher level pediatric resources. There were 44 pairs of patients that had sufficient EMS data documented to calculate a BPEWS. A BPEWS ≥ 7 demonstrated a sensitivity of 46.4 (95% CI 27.5-66.1) and a specificity of 76.7 (95% CI 64.0-86.6) to correctly classify a patient who required a hospital with higher level pediatric resources. Conclusion: In the prehospital setting neither PEWS nor BPEWS exhibited sufficient sensitivity for clinical use to accurately identify children who need a hospital with higher level pediatric resources. Further research should be conducted to identify variables that are captured by prehospital care providers and are associated with children who need a hospital with higher level pediatric resources.

Author(s)/Presenter(s)

John M Carey, Jonathan R Studnek, Lorin R Browne, Daniel G Ostermayer, Thomas Grawey, Stephanie Schroter, E Brooke Lerner, Manish I Shah

Abstract/Description

Background: Seizures have the potential to cause significant morbidity and mortality, and are a common reason emergency medical services (EMS) are requested for a child. An evidence-based guideline (EBG) for pediatric prehospital seizures was published and has been implemented as protocol in multiple EMS systems. Knowledge translation and protocol adherence in medicine can be incomplete. In EMS, systems-based factors and providers' attitudes and beliefs may contribute to incomplete knowledge translation and protocol implementation. Objective: The purpose of this study was to identify paramedic attitudes and beliefs regarding pediatric seizure management and regarding potential barriers to and enablers of adherence to evidence-based pediatric seizure protocols in multiple EMS systems. Methods: This was a qualitative study utilizing semi-structured interviews of paramedics who recently transported actively seizing 0-17 year-old patients in 3 different urban EMS systems. Interviewers explored the providers' decision-making during their recent case and regarding seizures in general. Interview questions explored barriers to and enablers of protocol adherence. Two investigators used the grounded theory approach and constant comparison to independently analyze transcribed interview recordings until thematic saturation was reached. Findings were validated with follow-up member-checking interviews. Results: Several themes emerged from the 66 interviewed paramedics. Enablers of protocol adherence included point-of-care references, the availability of different routes for midazolam and availability of online medical control. Systems-level barriers included equipment availability, controlled substance management, infrequent pediatric training, and protocol ambiguity. Provider-level barriers included concerns about respiratory depression, provider fatigue, preferences for specific routes, febrile seizure perceptions, and inaccurate methods of weight estimation. Paramedics suggested system improvements to address dose standardization, protocol clarity, simplified controlled substance logistics, and equipment availability. Conclusions: Paramedics identified enablers of and barriers to adherence to evidence-based pediatric seizure protocols. The identified barriers existed at both the provider and systems levels. Paramedics identified multiple potential solutions to overcome several barriers to protocol adherence. Future research should focus on using the findings of this study to revise seizure protocols and to deploy measures to improve protocol implementation. Future research should also analyze process and outcome measures before and after the implementation of revised seizure protocols informed by the findings of this study.

Author(s)/Presenter(s)

Brooke Lerner, Jonathan Studnek, Nicole Fumo, Anjishnu Banerjee, Igli Arapi, Lorin Browne, Daniel Ostermayer, Stacy Reynolds, Manish Shah

Abstract/Description

Background: Although all emergency departments (EDs) should be ready to treat children, some may have illnesses or injuries that require higher-level pediatric resources that are not available at all hospitals. There are no national guidelines for emergency medical services (EMS) providers about when to directly transport children to hospitals with higher-level pediatric resources, with the exception of severe trauma. Variability exists in EMS protocols about when children warrant transport to hospitals with higher-level pediatric care. Objective: The objective was to determine how frequently pediatric patients are transported by EMS to hospitals with higher-level pediatric resources and to evaluate distribution patterns based on illness and injury severity. Methods: We conducted a retrospective analysis of all pediatric (age 0-18 years) transports in three large EMS systems between November 2014 and November 2016. Each community had a hospital with higher-level pediatric resources that was within a 30-minute transport time from any location. Patients were included if they were transported by ground ambulance and the request originated in the 9-1-1 system. We assessed the frequency of transports to a hospital with higher-level pediatric resources. Data were stratified by chief complaint of illness or injury and severity. Potential risk for severe injury was defined as meeting the physiologic step of the field triage guidelines and potential risk for severe illness was defined as having an abnormal vital sign after adjusting for patient age. Results: A total of 41,345 pediatric patients were transported by a participating EMS agency to an ED and had complete destination data. A total of 55% of all EMS-transported pediatric patients were transported to a hospital with higher-level pediatric resources. There was variation by site (range = 45%-71%) in the percentage of children who went to a hospital with higher-level pediatric resources. Patients over 15 years of age went to general EDs (57%) more often than younger patients. When stratified by severity, 60% of those with potentially severe illness and 74% of those with potentially severe trauma were transported to a hospital with higher-level pediatric resources. Conclusions: EMS providers commonly transport children to hospitals with higher-level pediatric resources. However, more than one-quarter of children with potentially severe injuries and illnesses are transported to general EDs.

Author(s)/Presenter(s)

Jonathan Studnek, Brooke Lerner, Manish Shah, Lorin Browne, David Brousseau, Jeremy Cushman, Peter Dayan, Patrick Drayna, Amy Drendel, Matthew Gray, Christopher Kahn, Michael Meyer, Rachel Stanley

Abstract/Description

Background: Emergency medical services (EMS) providers must be able to identify the most appropriate destination facility when treating children with potentially severe medical illnesses. Currently, no validated tool exists to assist EMS providers in identifying children who need transport to a hospital with higher-level pediatric care. For such a tool to be developed, a criterion standard needs to be defined that identifies children who received higher-level pediatric medical care. Objective: The objective was to develop a consensus-based criterion standard for children with a medical complaint who need a hospital with higher-level pediatric resources. Methods: Eleven local and national experts in EMS, emergency medicine (EM), and pediatric EM were recruited. Initial discussions identified themes for potential criteria. These themes were used to develop specific criteria that were included in a modified Delphi survey, which was electronically delivered. The criteria were refined iteratively based on participant responses. To be included, a criterion required at least 80% agreement among participants. If an item had less than 50% agreement, it was removed. A criterion with 50% to 79% agreement was modified based on participant suggestions and included on the next survey, along with any new suggested criteria. Voting continued until no new criteria were suggested and all criteria received at least 80% agreement. Results: All 11 recruited experts participated in all seven voting rounds. After the seventh vote, there was agreement on each item and no new criteria were suggested. The recommended criterion standard included 13 items that apply to patients 14 years old or younger. They included IV antibiotics for suspicion of sepsis or a seizure treated with two different classes of anticonvulsive medications within 2 hours, airway management, blood product administration, cardiopulmonary resuscitation, electrical therapy, administration of specific IV/IO drugs or respiratory assistance within 4 hours, interventional radiology or surgery within 6 hours, intensive care unit admission, specific comorbid conditions with two or more abnormal vital signs, and technology-assisted children seen for device malfunction. Conclusion: We developed a 13-item consensus-based criterion standard definition for identifying children with medical complaints who need the resources of a hospital equipped to provide higher-level pediatric services. This criterion standard will allow us to create a tool to improve pediatric patient care by assisting EMS providers in identifying the most appropriate destination facility for ill children.

Author(s)/Presenter(s)

Stacy L. Reynolds, MD, Kathleen K. Bryant, MD, Jonathan R. Studnek, PhD, Melanie Hogg, Connell Dunn, Megan A. Templin, MS, Charity G. Moore, PhD, MSPH, James R. Young, MD, Katherine Rivera Walker, BSN, and Michael S. Runyon, MD, MPH

Abstract/Description

Objectives: We compared the tolerability and efficacy of intranasal subdissociative ketamine to intranasal fentanyl for analgesia of children with acute traumatic pain and investigated the feasibility of a larger noninferiority trial that could investigate the potential opioid-sparing effects of intranasal ketamine.

Methods: This randomized controlled trial compared 1 mg/kg intranasal ketamine to 1.5 μg/kg intranasal fentanyl in children 4 to 17 years old with acute pain from suspected isolated extremity fractures presenting to an urban Level II pediatric trauma center from December 2015 to November 2016. Patients, parents, treating physicians, and outcome assessors were blinded to group allocation. The primary outcome, a tolerability measure, was the frequency of cumulative side effects and adverse events within 60 minutes of drug administration. The secondary outcomes included the difference in mean pain score reduction at 20 minutes, the proportion of patients achieving a clinically significant reduction in pain in 20 minutes, total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the emergency department (ED) stay, and the feasibility of enrolling children presenting to the ED in acute pain into a randomized trial conducted under U.S. regulations. All patients were monitored until 6 hours after their last dose of study drug or until admission to the hospital ward or operating room.

Results: Of 629 patients screened, 87 received the study drug and 82 had complete data for the primary outcome (41 patients in each group). The median (interquartile range) age was 8 (6-11) years and 62% were male. Baseline pain scores were similar among patients randomized to receive ketamine (73 ± 26) and fentanyl (69 ± 26; mean difference [95% CI] = 4 [-7 to 15]). The cumulative number of side effects was 2.2 times higher in the ketamine group, but there were no serious adverse events and no patients in either group required intervention. The most common side effects of ketamine were bad taste in the mouth (37; 90.2%), dizziness (30; 73.2%), and sleepiness (19; 46.3%). The most common side effects of fentanyl were sleepiness (15; 36.6%), bad taste in the mouth (9; 22%), and itchy nose (9; 22%). No patients experienced respiratory side effects. At 20 minutes, the mean pain scale score reduction was 44 ± 36 for ketamine and 35 ± 29 for fentanyl (mean difference = 9 [95% CI = -4 to 23]). Procedural sedation with ketamine occurred in 28 ketamine patients (65%) and 25 fentanyl patients (57%) prior to completing the study.

Conclusions: Intranasal ketamine was associated with more minor side effects than intranasal fentanyl. Pain relief at 20 minutes was similar between groups. Our data support the feasibility of a larger, noninferiority trial to more rigorously evaluate the safety, efficacy, and potential opioid-sparing benefits of intranasal ketamine analgesia for children with acute pain.

Author(s)/Presenter(s)

Stacy L Reynolds, Jonathan R Studnek, Kathleen Bryant, Kelly VanderHave, Eric Grossman, Charity G Moore, James Young, Melanie Hogg, Michael S Runyon

Abstract/Description

Introduction: Fentanyl is the most widely studied intranasal (IN) analgesic in children. IN subdissociative (INSD) ketamine may offer a safe and efficacious alternative to IN fentanyl and may decrease overall opioid use during the emergency department (ED) stay. This study examines the feasibility of a larger, multicentre clinical trial comparing the safety and efficacy of INSD ketamine to IN fentanyl and the potential role for INSD ketamine in reducing total opioid medication usage.

Methods and analysis: This double-blind, randomised controlled, pilot trial will compare INSD ketamine (1 mg/kg) to IN fentanyl (1.5 μg/kg) for analgesia in 80 children aged 4-17 years with acute pain from a suspected, single extremity fracture. The primary safety outcome for this pilot trial will be the frequency of cumulative side effects and adverse events at 60 min after drug administration. The primary efficacy outcome will be exploratory and will be the mean reduction of pain scale scores at 20 min. The study is not powered to examine efficacy. Secondary outcome measures will include the total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the ED stay, number and reason for screen failures, time to consent, and the number and type of protocol deviations. Patients may receive up to 2 doses of study drug.

Ethics and dissemination: This study was approved by the US Food and Drug Administration, the local institutional review board and the study data safety monitoring board. This study data will be submitted for publication regardless of results and will be used to establish feasibility for a multicentre, non-inferiority trial.

Keywords

ketamine; pediatric orthopaedics; pain management