Improving the Management ofVaso-Occlusive Episodes in thePediatric Emergency DepartmentPatricia L. Kavanagh, MDa, Philippa G. Sprinz, MD, MSca, Tahlia L. Wolfgang, MPHa, Kelly Killius, PharmDb,Maria Champigny, LICSWc, Amy Sobota, MD, MPHa, David Dorfman, MDa, Karan Barry, BSNd, Renee Miner, BSNd,James M. Moses, MD, MPHa

abstract OBJECTIVES: Vaso-occlusive episodes (VOEs) account for the majority of emergencydepartment (ED) visits for children with sickle cell disease (SCD). We hypothesizedthat addressing key barriers to VOE care would improve receipt of analgesicsand outcomes.

METHODS: A quality improvement (QI) initiative was conducted from September 2010to April 2014 to streamline VOE care in an urban pediatric ED. Four interventionswere used: a standardized time-specific VOE protocol; intranasal fentanyl as the firstparenteral pain medication; an SCD pain medication calculator; and provider andpatient/family education. Data were collected for 3 outcome measures (mean timefrom triage to first parenteral opioid and admission/discharge decision, andproportion discharged from the ED); 1 process measure (mean time from triage toinitiation of patient-controlled analgesia); and 4 balancing measures (mean timefrom triage to second intravenous opioid dose, 24-hour ED readmission, respiratorydepression, and length of stay).

RESULTS: There were 289 ED visits in the study period. Improvements were seen inmean time to: first dose of parenteral opioid (56 to 23 minutes); second opiateintravenous dose (106 to 83 minutes); admission and discharge decisions (163 to109 minutes and 271 to 178 minutes, respectively); and initiation of patient-controlled analgesia (216 to 141 minutes). The proportion discharged from the EDincreased from 32% to 48% (x2 = 6.5402, P = .01). No increase in 24-hourreadmission, respiratory depression, or inpatient length of stay was observed.

CONCLUSIONS: Using VOE-specific interventions, we significantly improved VOE carefor children. Studies are needed to determine if these results can be replicated.

Approximately 100 000 people areliving with sickle cell disease (SCD) inthe United States.1,2 Vaso-occlusiveepisodes (VOEs) are a significant causeof morbidity for subjects with SCD andaccount for the majority of emergencydepartment (ED) visits andhospitalizations among both adults3,4

and children.5 The National Heart,Lung, and Blood Institute and theAmerican Pain Society recommendrapid evaluation and treatment of VOEsin the acute care setting, with timelypain assessments and repeat analgesiaas needed to control pain.6,7 In

addition, quality-of-care indicators forchildren with SCD include the receiptof parenteral analgesia within30 minutes of triage in the ED orcomparable setting to treat VOEs.8

Despite these recommendations,studies of children with SCD presentingto the ED for VOE managementhave reported wait times of 65 to90 minutes for the first dose ofparenteral analgesia.9–11 These findingsare supported by a qualitative study ofadolescents with SCD and parents ofchildren with SCD, who reported delays

aDepartment of Pediatrics, Boston University School ofMedicine/Boston Medical Center, Boston, Massachusetts;and Departments of bPharmacy, cSocial Work, anddNursing, Boston Medical Center, Boston, Massachusetts

Drs Kavanagh and Moses conceptualized anddesigned the study; were involved in the design,revision, and implementation of the interventions;performed data analyses; and drafted the initialmanuscript and its revision. Ms Wolfgang assisted inthe design and revisions of the interventions used;performed data collection and data analyses; andcontributed to the final manuscript. Dr Killius,Dr Sprinz, Dr Sobota, Ms Champigny, Ms Miner,Ms Barry, and Dr Dorfman assisted in designing andrevising the interventions used; provided feedbackon data analyses; and contributed to the finalmanuscript as submitted. All authors approved thefinal version of the manuscript.

www.pediatrics.org/cgi/doi/10.1542/peds.2014-3470

DOI: 10.1542/peds.2014-3470

Accepted for publication Apr 14, 2015

Address correspondence to Patricia L. Kavanagh,MD, Boston University School of Medicine/BostonMedical Center, 88 E. Newton St, Vose Hall, 3rd Floor,Boston, MA 02118. E-mail: patricia.kavanagh@bmc.org

PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online,1098-4275).

Copyright © 2015 by the American Academy ofPediatrics

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in receiving pain medications in theED.12 According to a report fromthe Institute of Medicine, 1 reason forthe suboptimal management of pain isinadequate provider knowledge.13

Other studies have shown thatunfounded provider beliefs aboutaddiction also contribute to delays inproviding analgesia, including for SCD-related pain.14

To address these concerns, weconducted a quality improvement(QI) initiative to improve thetimeliness of VOE management forchildren with SCD in the pediatric ED.Our specific aims were to decreasethe mean time to first parenteral painmedication to #30 minutes, improvethe timeliness of subsequent painmedications, and decrease the time todisposition decision.

METHODS

Setting

This QI initiative was conducted inan urban pediatric ED designated asa Level II trauma center. The centerreceives 28 000 visits annually inpatients aged #21 years, including∼180 children and young adults withSCD followed up in our institution’spediatric hematology clinic. Amultidisciplinary team was createdthat met biweekly, consisting of:pharmacy, nursing, and physicianstaff from the pediatric ED; pediatrichematologists and a social worker;a pediatric hospitalist with QIexpertise; the parent of a child withSCD; and a project coordinator.

Patient Population

For this initiative, patients with SCDpresenting with moderate or severeVOE pain (eg, $5 of 10 on theNumeric Pain Rating Scale15) wereincluded. Patients were excluded ifthey presented with non-VOE pain,headache, atypical (non-VOE) chestpain or asthma exacerbation,abdominal pain, extremity pain orswelling concerning for deep veinthrombosis, pain due to trauma or

musculoskeletal causes, or fever.Also excluded were visits forpatients who had an implanted port(because they followed a separateprotocol), patients withindividualized pain plans addressingboth VOE pain and concomitantpsychosocial issues, and thosetransferred from outside EDs.

Interventions

Key drivers of streamlined care forVOEs in the pediatric ED wereidentified (Fig 1). Four rate-limitingsteps were identified: (1) lack ofknowledge and wide variation of carefor VOEs; (2) establishing intravenous(IV) access; (3) calculating andconfirming appropriate painmedication doses; and (4)misconceptions about thepresentation and treatment of VOEsand future behaviors in thispopulation regarding painmanagement. Using Plan-Do-Study-Act cycles based on the Model forImprovement,16 4 interventions weredeveloped: (1) a standardized time-specific VOE protocol; (2) intranasalfentanyl as the first parenteral painmedication; (3) an SCD painmedication calculator; and (4)provider and patient/familyeducation.

Standardized VOE Algorithm

We developed a standardizedalgorithm for those presenting withmoderate to severe VOE pain:2 doses of intranasal fentanyl 5 to10 minutes apart, followed by 2doses of IV opioids every 20 to 30minutes (Appendix). For childrenaged $7 years requiring admission,patient-controlled analgesia (PCA)was initiated in the ED, which was anaccepted practice but not uniformlyimplemented before this QI initiative.Those discharged were observed for1 hour after receiving oral opioids toensure appropriate pain control.Physicians were permitted to tailorcare for individual patients but wereasked to explain any deviationsmade.

Intranasal Fentanyl

Intranasal fentanyl was chosen asthe first parenteral pain medicationfor VOE treatment because of delaysassociated with obtaining IV access.Intranasal fentanyl has been shownto be safe and efficacious in thepediatric ED, including our own, forconditions such as long bonefractures.17,18 We believed thatintranasal fentanyl could providerapid relief for VOEs as IV access wasestablished while minimizing therisk of opioid overdose given itsquick onset of action and shortduration.19 This expanded indicationwas approved by our institution’spharmacy and therapeuticscommittee for children with SCDweighing $10 kg to include 2 doses,each 1.5 mg/kg (maximum singledose: 100 mg) administered 5 to10 minutes apart.

SCD Pain Medication Calculator

Subjects with SCD often need higherdoses of opioids to achieve adequateanalgesia due to the higher painintensity associated with VOEs,tolerance to opioids, and increasedrenal and hepatic clearance.7 Duringthis initiative, the electronic healthrecord used in the pediatric ED didnot provide age- and weight-baseddosing for children with SCD.Through a collaborative effort of thepediatric ED, hematology, andpharmacy staff, an online SCD painmedication calculator wastherefore developed for theanalgesics commonly used for VOEs;an age- and weight-based dosingscheme was employed (Appendix).This tool was completed at thetime of care initiation and thenused by nurses to check medicationdosing.

Provider and Patient/Family Education

The Institute of Medicine has citedthe limited education of US medicalstudents and physicians as a majorchallenge in the treatment of pain.13

We therefore held trainings forpediatric ED providers on the VOE

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protocol, the use of the painmedication calculator, and useful tipson the assessment and treatment ofVOEs. These sessions also addressedcommon misperceptions, such asassuming that a sleeping child withVOE had adequately controlled painor that normal vital signs could notbe present in those experiencingsignificant pain. We also discussedthat self-reported pain scores werethe gold standard and debunkedmyths, including that there is noincreased risk of addiction oraberrant drug-seeking behavior inthis population.20,21 Education wasalso provided to patients and parentsin the pediatric hematology clinicand ED to explain the care steps forVOEs, especially the use of intranasalfentanyl as the first treatmentprovided. In addition, from Maythrough September 2011, thepediatric hematology social workersurveyed a convenience sample ofpatients and/or parents to assesstheir experiences and providefeedback to the multidisciplinaryteam.

Project Timeline

This initiative lasted from September2010 to April 2014. At baseline(September 2010–May 2011), dataon the timing of first and subsequentpain medications for childrenwith SCD presenting with VOEwere collected. In phase 1(May–November 2011), intranasalfentanyl as the first-line parenteralopioid was introduced. In phase 2(December 2011–November 2012),the goal was to streamline VOE carefrom triage to disposition decision.We revised the VOE algorithm torecommend 2 doses of intranasalfentanyl, 2 doses of IV opioids,and then a disposition decision; wethen introduced the SCD painmedication calculator. In phase 3(December 2012–April 2014), thesustainability of the improvementsseen in phase 2 was determined.We also revised the VOE algorithmin May 2013 to initiate PCA forpatients with severe pain ($7 of 10on the Numeric Pain RatingScale15) following the first dose ofIV opioid after determining that

95% of these patients requiredadmission.

Outcome, Process, and BalancingMeasures

Our primary outcome measures weremean time from triage to firstparenteral (IV or intranasal) opioidand mean time from triage toadmission or discharge decision. Inaddition, mean time from triage toPCA initiation was tracked forpatients requiring admission asa process measure to limit the gapbetween receipt of intermittent IVopioids and PCA. Finally, theproportion of visits for VOEs that ledto discharge before and afterstreamlined care (baseline + phase 1vs phase 2 + phase 3) wasdetermined.

Our balancing measures includedmean time from triage to the secondIV opioid dose to ensure that the useof intranasal fentanyl as the first-lineintervention was not delayingsubsequent IV dosing. In addition,we monitored the safety of ourefforts by collecting data on 3

FIGURE 1Streamlined care for uncomplicated SCD VOE in the pediatric ED. aBaseline data indicated that patients were already being triaged upon arrival andplaced into an acute bed. RN, registered nurse.

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measures: (1) those who returned tothe ED within 24 hours of discharge;(2) episodes of respiratorydepression in the ED or duringhospitalization; and (3) inpatientlength of stay.

Data Analysis

Statistical process control chartswere used to determine howpediatric ED processes of VOE carechanged over time, namely, times to:(1) administration of the firstparenteral opioid; (2) admission ordischarge decision; (3) initiation ofPCA; and (4) second IV opioid dose.These charts consist of upper andlower limits, set at 3 SDs from themean (depicted as the central line onthe graphics). The statistical processcontrol charts displayed variationsnoted in results generated bya process22,23 and quickly identifiedpatterns as changes were made(including sustained improvements)as the sample size increased overtime.22 To assess if significantdifferences existed in the proportiondischarged from the ED andinpatient length of stay between thebefore and after streamlined careperiods, x2 analyses were used. Thisstudy was approved by the BostonUniversity Medical CampusInstitutional Review Board.

RESULTS

From September 2010 to April 2014,a total of 1093 visits were made tothe pediatric ED by children withSCD; 672 (61.5%) visits were for thetreatment of pain. We excluded 247visits for non-VOE pain or paincomplicated by fever. Also excludedwere 61 visits in which the VOEprotocol was not used (eg, mild

pain). Finally, 44 visits for patientswith a port, 18 visits for 4 patientsmanaged with individualizedtreatment plans, and 13 ED transferswere excluded. Thus, 289 visits wereanalyzed for moderate to severeVOEs, representing 83 patients witha median of 2 visits (range: 1–34visits) who ranged in age from 2 to21 years; 64% of visits were made bythose aged $18 years. The meannumber of patients per month andthe percent with hemoglobin SSdisease did not differ for each timeperiod (Table 1).

Outcome Measures

Mean time to first dose of parenteralopioid improved from 56 to 23minutes (Fig 2). The percentage ofvisits in which the first dose ofparenteral opioid was provided in#30 minutes increased from 41% to75%, paralleling the increase ofintranasal fentanyl given as the firstopioid, from 39% to 75%. Mean timeto admission and discharge decisionsdecreased from 163 to 109 minutesand from 271 to 178 minutes,respectively (Figs 3 and 4). Inaddition, the proportion of childrendischarged from the ED before andafter the introduction of streamlinedcare in December 2012 increasedsignificantly, from 32% to 48%(x2 = 6.54, P = .01). Notably, theproportion of young adults aged 18to 21 years, who often have highrates of ED utilization, did notsignificantly differ between theseperiods (70% vs 61%; x2 = 2.28,P = .13).

Process and Balancing Measures

Time to PCA initiation declined from216 to 141 minutes over the study

period. In addition, time to secondopioid IV dose decreased from 106to 83 minutes, despite the additionof intranasal fentanyl (Fig 5). Inaddition, 9 repeat ED visits occurredwithin 24 hours of discharge; 4 weredue to the inability to fillprescriptions for oral painmedications, and only 1 occurredafter the introduction of streamlinedVOE care. Hypoxia occurred in 3 EDvisits in 3 different patients, onceeach at baseline, phase 1, and phase3; none developed respiratorydepression or acute chest syndromeduring their subsequent inpatientstay. Finally, median inpatient lengthof stay before and after streamlinedVOE care remained the same at 5days.

DISCUSSION

In this QI initiative, we reportedsignificant improvements in the careof children with SCD presenting to thepediatric ED with moderate to severeVOEs by using interventions designedto streamline care. Theseinterventions included the use ofa VOE algorithm with explicitlydefined care steps and intranasalfentanyl as the first parenteral opioid,a pain calculator, and education ofpediatric ED providers, patients, andfamily members. These interventionsaddressed key barriers to appropriatepain management, includingobtaining timely IV access,medication dose determination andconfirmation, and a lack of a sharedmental model among providers,patients, and families. By addressingthese barriers, we successfullyprovided initial parenteral painmedication in #30 minutes of triage(per national guidelines)6,7 and

TABLE 1 Demographic Information on the Intervention Population

Characteristic Baseline Phase 1: Introduction of Intranasal Fentanyl Phase 2: Streamlined Care Phase 3: Maintenance

No. of visits 49 51 76 113No. of patients 22 28 41 37Age, median (range), y 18 (10–21) 18 (2–21) 19 (4–21) 20 (2–21)% of children aged $18 y 82 59 57 65HbSS genotype, % 83.7 84.3 80.3 81.4

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observed significant improvements inthe average time to second IV painmedication, disposition decision, andPCA initiation for those admitted.Moreover, these improvements havebeen sustained for .3 years, and wedid not find any change in negativeoutcomes. From these data, we believethat our interventions were botheffective and safe in the managementof VOEs for children with SCD.

Previous studies have demonstratedthe benefit of using guidelines tostandardize care for VOEs, includingdecreasing hospital admissions24 andestablishing more consistent painassessments, use of weight-baseddosing, and time to PCAinitiation.10,25 However, in thesestudies, the timeliness of parenteralpain management did not meetrecommendations by national experts

(eg, first parenteral analgesic in #30minutes).6–8 A key difference in ourstudy was the focus on explicitlydefining the care steps and time goalsfor the entire ED visit. By creatinga standardized approach, we definedthe roles and expectations for allproviders on the care team to ensuretimely and effective pain management.

To our knowledge, there are nopublished studies on the use of

FIGURE 2Mean time from triage to first parenteral opioid (intranasal [IN] or IV route). UCL, upper control limit.

FIGURE 3Mean time from triage to admission decision. There were no admissions in April 2011, July 2012, and June 2013 and only 1 admission in May 2013. Theupper control limit (UCL) was not calculated for these time points. IN, intranasal.

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intranasal fentanyl in the ED forchildren with SCD presenting withVOEs, although a protocol fora randomized trial has beenpublished.26 A single-center studydemonstrated an improvement intime to initial analgesic

administration with the use ofintranasal fentanyl for pediatricpatients presenting with moderate tosevere pain, similar to theimprovement seen with our study.27

We join others in advocating for theuse of alternative routes in those with

SCD to provide rapid analgesia,including intranasal fentanyl, becauseIV access becomes more challengingdue to scarring as these patientsage.28 In addition, intranasalfentanyl’s rapid onset and shortduration19 provide pain relief and

FIGURE 4Mean time from triage to discharge decision. There were no discharges in September 2010, September 2011, November 2011, February 2012, May 2013,July 2013, January 2014, February 2014, and March 2014; and there was only 1 discharge in April. Therefore, no upper control limit (UCL) limit wascalculated after December 2013. IN, intranasal.

FIGURE 5Mean time from triage to second IV opioid (after most received 2 intranasal [IN] and 1 IV dose of opioids). UCL, upper control limit.

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limit the potential “stacking” withsubsequent IV opioids, therebylimiting the occurrence of respiratorydepression associated with repeatdosing.

At the time of the present study, theelectronic health record used in ourpediatric ED did not provide age- orweight-based calculations foranalgesics commonly used in VOEtreatment. By creating a tool thatprovided appropriate age- andweight-based dosing ranges, wefacilitated the ordering process anddose verification. Electronic healthrecords are now used in 95% ofhospitals in the United States.29 Asthese systems continue to be refinedfor care settings and patientpopulations, special attention needsto be paid to the care of children withSCD presenting with VOE so that theirpain is managed appropriately.

There were several limitations to ourstudy. First, our effort was a QIinitiative, and several of the lessonslearned are drawn from 1 local caresetting and context and, therefore, arenot generalizable. However, webelieve the interventions describedhere may be useful in otherinstitutions, as the barriers to timelycare are likely similar. Second, we didnot consistently track when thealgorithm was used for individualpatients throughout this QI initiative.However, the sustained use ofintranasal fentanyl and provision of

timely care suggest that these toolswere used routinely to manage VOE.Third, we did not record any adverseevents in the course of this study;however, we did not power the studyto formally assess this outcome. Closemonitoring is therefore warranted forall children receiving this level ofcare. Fourth, the maximum dosing ofintranasal fentanyl is 100 mg per dosedue to concentration and volumeconstraints; therefore, subtherapeuticdoses were administered to thoseweighing .65 kg. However, we mayhave achieved greater pain capture inthese patients by providing rapidlyacting analgesia sooner during the EDvisit. Finally, we did not use change inpain scores as an outcome measurebecause documentation of pain scoreswas problematic in the first year ofour study, as previously described inpublished reports.30,31 We did finda significant increase in theproportion of children dischargedfrom the ED, and we therefore believethat a clinically significantimprovement in pain was achieved asa result of our interventions.

CONCLUSIONS

We used QI methods to improve thecare of children with SCD presentingto the ED for VOEs. Through the useof a standardized algorithm thatincluded intranasal fentanyl,improving pain medication orderingand verification, and educating

providers, patients, and families, wehave met and exceeded nationalrecommendations and sustainedthese gains over time. Futureresearch is needed to determine ifthese results can be replicated inother pediatric EDs. In addition,examination of each interventionused in this study is needed todetermine how each contributed toour results. Finally, perspectives ofproviders, patients, and families areneeded to understand how theseefforts impact VOE care and toidentify additional areas that requireimprovement.

ACKNOWLEDGMENTS

We acknowledge the patients andfamilies with SCD and all the medicalstaff in the pediatric ED whosupported our efforts and providedinvaluable feedback on this initiativethat contributed to its success. Wealso thank Barry Zuckerman, MD, andRobert Vinci, MD for their support ofthis research.

ABBREVIATIONS

ED: emergency departmentIV: intravenousPCA: patient-controlled analgesiaQI: quality improvementSCD: sickle cell diseaseVOE: vaso-occlusive episode

FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.

FUNDING: Supported by grant U38MC22215 from the Health Resources and Services Administration’s Sickle Cell Disease Newborn Screening Program.

POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.

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APPENDIX STANDARDIZED VOE ALGORITHM

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DOI: 10.1542/peds.2014-3470 originally published online September 21, 2015; 2015;136;e1016Pediatrics Moses

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Emergency DepartmentImproving the Management of Vaso-Occlusive Episodes in the Pediatric

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