There was a significant reduction in electronic SLRs filed about heel sticks after implementation of the Children's Comfort Promise, procedure and nursing time decreased, and average patient wait times decreased. During observations, it was noted that nurses and phlebotomists rarely collaborated during laboratory draws, and babies experienced distress throughout the procedure as evidenced by crying, kicking, increased heart rate, oxygen desaturations, and heel bruising. Nurses raised concerns that our recommendations to be present for all laboratory draws to provide comfort to the infants during the procedure would be too time-consuming. However, time studies were undertaken and were discontinued after only 2 collection periods after implementation because there was compelling evidence that comforting babies after procedure was more time-consuming than time spent when involved in the procedure. Safety learning reports for complications with heel sticks decreased by 50% since implementation of the Comfort Promise measures, with most infants now sleeping through their laboratory draws. Time duration to undertake the needle procedures was not lengthened by implementation of the Comfort Promise. For instance, in the neonatal areas, nurses spent 40% less time in the room, and the total procedure time was decreased by 60%, whereas in the outpatient laboratory, wait and procedure times were reduced by 20% from 20 minutes to 16 minutes in 6 months and sustained over time.
This is the first report of a successful system-wide implementation of a protocol to reduce or eliminate needle pain, including pain from vaccinations, in a children's hospital for all inpatient units, EDs, outpatient laboratories, and ambulatory clinics by offering a bundle of topical anesthesia, sucrose/breastfeeding, positioning, and distraction. An estimated 200,000 children now benefit annually from the Comfort Promise initiative to reduce and eliminate pain caused by elective blood draws, intravenous access, and injections. Wait times decreased and patient satisfaction increased between 2014 and 2016.
Organizational culture has been identified as key to changing pain management practices.6,8,32,67 Published studies indicate that making pain management an organizational priority can improve practices. Quality improvement pain studies to date are promising,49 although generally small scale with change not always being evaluated over a sustained period.16,36,43,53,69 This structured initiative was successful both due to staff and leadership support, which included a letter signed by the Children's Minnesota Chief Executive Officer, Chief Operating Officer, Chief Nursing Officer, and Chief Medical Officer stating that, as an institution, we will offer the bundled services, including topical anesthesia, to all patients and that we will not hold children down for elective needle procedures. The decision of the organization to supply 4% lidocaine in all service areas (removing the burden for families) was critical to the success of the process. This was achieved through early efforts to work with the Minnesota Department of Human Services to secure reimbursement for 4% lidocaine as an essential over-the-counter pain medication. Approval was secured in April 2014. Despite its availability, the 30-minute wait time for the cream was still a deterrent to its use but concerns were reduced after time studies that showed a decrease in wait times and time needed to address adverse reactions to blood draws. Work has been ongoing in the ambulatory setting to educate families about placing cream properly before their visit and to further improvements in workflow to accommodate early placement of the cream.
A framework for implementation was essential because education and policy alone are often insufficient.69 Supporting and encouraging multidisciplinary staff members who created processes and embraced the Comfort Promise was important, as was putting institutional resources behind the change initiative. This included mobilizing a full-time clinical resource team (nurse, child life, and lean staff member) supported by a physician champion. Because change happens through influence rather than by command,22 the main aim of the Comfort Promise team was to establish trust and ensure engagement of the front-line staff, to build a culture that would foster and sustain meaningful change across roles and responsibilities.72 Culture shift takes time and patience. Although over 75% of the children were offered or received the bundled services in nearly all areas within 2 months of rollout, it took 9 months for the first inpatient unit to consistently offer all 4 best practice strategies for 95% of needle procedures. This was a relatively short period, considering the fact that it took our institution 4 years to increase adherence to hand-washing policies from 50% to over 94%.
The rollout of the “Comfort Promise” was associated with increases in patient satisfaction (Figs. 3 and 4). Although we cannot demonstrate causation, there were no other pain-directed, system-wide initiatives implemented in the period. Reasons for a temporary decrease in Q4 2015 may include regression to the mean, expected statistical variation, or uncontrolled covariates (such as possible longer waits in the ED and/or decreased staff willingness to offer the bundled modalities during a busy winter 2015/2016 season).
Resistance toward implementation at the individual staff and unit level presented challenges during the rollout process. We found that the key to overcoming this resistance was providing necessary resources, support, and training to staff: “The new way had to be easier than the old way.” When we could demonstrate that wait times went down instead of up (as often anticipated by staff); that topical anesthetics did not decrease the chance of venous cannulation (there was not a single report of venous constriction impeding cannulation, confirming published data38,48); and—most importantly—that the 4 strategies provided an immediate benefit to patients (eg, fewer tears; more calm and cooperative children), the Comfort Promise was embraced by nearly all staff. The Lean Value Stream process involves regular process audits, implementation of knowledge translation strategies,76 development of educational and outreach materials (see supplemental figure for an example, available at http://links.lww.com/PR9/A24), and utilization of PDSA cycles. After implementing the Children's Comfort Promise for needles institution-wide, we tied leadership performance improvement bonuses to successful achievement of target goals. The new care standard was integrated into all organizational policies, the electronic medical record, and new staff orientation, making nonadherence a performance issue.
Analgesic treatment is mandatory for children undergoing painful procedures, and avoidable suffering is unacceptable, even for the so-called minor interventions.4,13 Findings from this institution-wide QI project targeting pain associated with needle procedures, along with similar findings at other institutions, suggest that QI strategies coupled with knowledge translation strategies are key components of successful pediatric pain management strategies at the institutional level.56,76 The Children's Comfort Promise has become our institution's new standard of care for needle procedures. It has drawn institution-wide, interdisciplinary attention, resulting in increased awareness of the importance of optimal pain management for all patients and families. This in turn will be an important catalyst in the development and rollout of future local and national interventions aimed at minimizing various sources of pain.
None of the authors have any financial or other conflicts of interest to report.
The authors thank all Children's Minnesota employees, the Children's Minnesota Youth Advisory Council, Family Advisory Council, members of the Comfort Promise Core Advisory Team (Maura Fitzgerald, Barbara Symalla, Jeri Kayser, Melissa Haun, Julie Yang, and Mary Hendricks), Alison Kolste for her thorough review of this manuscript, and our executive sponsors, Roxanne Fernandes and Phil Kibort. The authors appreciate their continued support, time, and dedication to making the Children's Comfort Promise initiative a sustainable success.
Supplemental digital content
Supplemental digital content associated with this article can be found online at http://links.lww.com/PR9/A24.
. Anand KJ, Barton BA, McIntosh N, Lagercrantz H, Pelausa E, Young TE, Vasa R. Analgesia and sedation in preterm neonates who require ventilatory support: results from the NOPAIN trial. Neonatal Outcome and Prolonged Analgesia in Neonates. Arch Pediatr Adolesc Med 1999;153:331–8.
. Barker DP, Rutter N. Exposure to invasive procedures in neonatal intensive care unit admissions. Arch Dis Child Fetal Neonatal Ed 1995;72:F47–F48.
. Bellieni CV, Johnston CC. Analgesia, nil or placebo to babies, in trials that test new analgesic treatments for procedural pain
. Acta Paediatr 2016;105:129–36.
. Birnie KA, Chambers CT, Fernandez CV, Forgeron PA, Latimer MA, McGrath PJ, Cummings EA, Finley GA. Hospitalized children continue to report undertreated and preventable pain. Pain Res Manag 2014;19:198–204.
. Botti M, Bucknall T, Manias E. The problem of postoperative pain: issues for future research. Int J Nurs Pract 2004;10:257–63.
. Bovier PA, Charvet A, Cleopas A, Vogt N, Perneger TV. Self-reported management of pain in hospitalized patients: link between process and outcome. Am J Med 2004;117:569–74.
. Bucknall T, Manias E, Botti M. Acute pain management: implications of scientific evidence for nursing practice in the postoperative context. Int J Nurs Pract 2001;7:266–73.
. Carbajal R, Rousset A, Danan C, Coquery S, Nolent P, Ducrocq S, Saizou C, Lapillonne A, Granier M, Durand P, Lenclen R, Coursol A, Hubert P, de Saint Blanquat L, Boelle PY, Annequin D, Cimerman P, Anand KJ, Breart G. Epidemiology and treatment of painful procedures in neonates in intensive care units. JAMA 2008;300:60–70.
. Centre for Pediatric Pain
Research. It doesn't have to hurt. Halifax, Nova Scotia, Canada: Centre for Pediatric Pain
Research, 2016. http://itdoesnthavetohurt.ca
. CHEO's Be Sweet to Babies Research Team and the University of Ottawa's School of Nursing. Be sweet to babies. Ottowa, Ontario, Canada: Children's Hospital of Eastern Ontario, 2014. http://www.cheo.on.ca/en/BeSweet2Babies
. Edwards KM, Hackell JM; Committee on Infectious Diseases, The Committee on Practice and Ambulatory Medicine. Countering vaccine hesitancy. Pediatrics 2016;138:e20162146.
. Ellis JA, McCleary L, Blouin R, Dube K, Rowley B, MacNeil M, Cooke C. Implementing best practice pain management in a pediatric hospital. J Spec Pediatr Nurs 2007;12:264–77.
. Friedrichsdorf SJ. Nitrous gas analgesia and sedation for lumbar punctures in children: has the time for practice change come? Pediatr Blood Cancer 2017;64:e26625.
. Friedrichsdorf SJ, Eull D, CA W. Children's Comfort Promise: how can we do everything possible to prevent and treat pain in children using quality improvement
strategies? (Commentary). Pediatr Pain Lett 2016;18:26–30.
. Friedrichsdorf SJ, Postier A, Eull D, Weidner C, Foster L, Gilbert M, Campbell F. Pain outcomes in a US Children's hospital: a prospective cross-sectional survey. Hosp Pediatr 2015;5:18–26.
. Gao H, Gao H, Xu G, Li M, Du S, Li F, Zhang H, Wang D. Efficacy and safety of repeated oral sucrose
for repeated procedural pain
in neonates: a systematic review. Int J Nurs Stud 2016;62:118–25.
. Graban M. Lean
hospitals: improving quality, patient safety, and employee engagement. New York, NY: CRC Press, 2016.
. Grenny J, Patterson K, Maxfield D, McMillan R, Switzler A. Influencer: the new science of leading change. New York, NY: McGraw-Hill Education Books, 2013.
. Grunau RE, Whitfield MF, Petrie-Thomas J, Synnes AR, Cepeda IL, Keidar A, Rogers M, Mackay M, Hubber-Richard P, Johannesen D. Neonatal pain, parenting stress and interaction, in relation to cognitive and motor development at 8 and 18 months in preterm infants. PAIN 2009;143:138–46.
. Guideline statement: management of procedure-related pain in children and adolescents. J Paediatr Child Health 2006;42(suppl 1):S1–S29.
. Haller G, Agoritsas T, Luthy C, Piguet V, Griesser AC, Perneger T. Collaborative quality improvement
to manage pain in acute care hospitals. Pain Med 2011;12:138–47.
. Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract 1995;41:169–75.
. Hurst K. Top-down and bottom-up quality management [editorial]. Int J Health Care Qual Assur 2010;23:629–30.
. Johnston CC, Collinge JM, Henderson SJ, Anand KJ. A cross-sectional survey of pain and pharmacological analgesia in Canadian neonatal intensive care units. Clin J Pain 1997;13:308–12.
. Jordan-Marsh M, Hubbard J, Watson R, Deon Hall R, Miller P, Mohan O. The social ecology of changing pain management: do I have to cry? J Pediatr Nurs 2004;19:193–203.
. Karlson K, Darcy L, Enskär K. The use of restraint is never supportive (poster). Nordic Society of Pediatric Hematology/Oncology (NOPHO) 34th Annual meeting 2016 and 11th Biannual Meeting of Nordic Society of Pediatric Oncology Nurses (NOBOS); May 27–31, 2016. Reykjavik, Iceland.
. Kelly AM. Patient satisfaction with pain management does not correlate with initial or discharge VAS pain score, verbal pain rating at discharge, or change in VAS score in the Emergency Department. J Emerg Med 2000;19:113–16.
. Kennedy A, Basket M, Sheedy K. Vaccine attitudes, concerns, and information sources reported by parents of young children: results from the 2009 HealthStyles survey. Pediatrics 2011;127(suppl 1):S92–S99.
. Langley GL, Moen R, Nolan KM, Nolan TW, Norman CL, Provost LP. The improvement guide: a practical approach to enhancing organizational performance. San Francisco: Jossey-Bass Publishers, 2009.
. Livingston M, Lawell M, McAllister N. Successful use of nitrous oxide during lumbar punctures: a call for nitrous oxide in pediatric oncology clinics. Pediatr Blood Cancer 2017;64:e26610.
. Lunoe MM, Drendel AL, Brousseau DC. The use of the needle-free jet injection system with buffered lidocaine device does not change intravenous placement success in children in the emergency department. Acad Emerg Med 2015;22:447–51.
. Lunoe MM, Drendel AL, Levas MN, Weisman SJ, Dasgupta M, Hoffmann RG, Brousseau DC. A randomized clinical trial of jet-injected lidocaine to reduce venipuncture pain for young children. Ann Emerg Med 2015;66:466–74.
. McClam Liebengood S, Cooper M, Nagy P. Going to the gemba: identifying opportunities for improvement in radiology. J Am Coll Radiol 2013;10:977–9.
. McMurtry CM, Pillai Riddell R, Taddio A, Racine N, Asmundson GJ, Noel M, Chambers CT, Shah V; HELPinKids&Adults Team. Far from “Just a Poke”: common painful needle procedures and the development of needle fear. Clin J Pain 2015;31(10 suppl):S3–S11.
. McMurtry CM, Taddio A, Noel M, Antony MM, Chambers CT, Asmundson GJ, Pillai Riddell R, Shah V, MacDonald NE, Rogers J, Bucci LM, Mousmanis P, Lang E, Halperin S, Bowles S, Halpert C, Ipp M, Rieder MJ, Robson K, Uleryk E, Votta Bleeker E, Dubey V, Hanrahan A, Lockett D, Scott J. Exposure-based interventions for the management of individuals with high levels of needle fear across the lifespan: a clinical practice guideline and call for further research. Cogn Behav Ther 2016;45:217–35.
. Megens JH, Van Der Werff DB, Knape JT. Quality improvement
: implementation of a pain management policy in a university pediatric hospital. Paediatr Anaesth 2008;18:620–7.
. Moraros J, Lemstra M, Nwankwo C. Lean
interventions in healthcare: do they actually work? A systematic literature review. Int J Qual Health Care 2016;28:150–65.
. Poksinska B. The current state of Lean
implementation in health care: literature review. Qual Manag Health Care 2010;19:319–29.
. Roofthooft DW, Simons SH, Anand KJ, Tibboel D, van Dijk M. Eight years later, are we still hurting newborn infants? Neonatology 2014;105:218–26.
. Schreiber S, Ronfani L, Chiaffoni GP, Matarazzo L, Minute M, Panontin E, Poropat F, Germani C, Barbi E. Does EMLA cream application interfere with the success of venipuncture or venous cannulation? A prospective multicenter observational study. Eur J Pediatr 2013;172:265–8.
. Schurman JV, Deacy AD, Johnson RJ, Parker J, Williams K, Wallace D, Connelly M, Anson L, Mroczka K. Using quality improvement
methods to increase use of pain prevention strategies for childhood vaccination
. World J Clin Pediatr 2017;6:81–8.
. Schwenkglenks M, Gerbershagen HJ, Taylor RS, Pogatzki-Zahn E, Komann M, Rothaug J, Volk T, Yahiaoui-Doktor M, Zaslansky R, Brill S, Ullrich K, Gordon DB, Meissner W. Correlates of satisfaction with pain treatment in the acute postoperative period: results from the international PAIN OUT registry. PAIN 2014;155:1401–11.
. Shah PS, Herbozo C, Aliwalas LL, Shah VS. Breastfeeding
or breast milk for procedural pain
in neonates. Cochrane Database Syst Rev 2012;12:CD004950.
. Shomaker K, Dutton S, Mark M. Pain prevalence and treatment patterns in a US children's hospital. Hosp Pediatr 2015;5:363–70.
. Simons J, MacDonald LM. Changing practice: implementing validated paediatric pain assessment tools. J Child Health Care 2006;10:160–76.
. Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey AS. Sucrose
for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev 2016;7:CD001069.
. Stevens BJ, Harrison D, Rashotte J, Yamada J, Abbott LK, Coburn G, Stinson J, Le May S. Pain assessment and intensity in hospitalized children in Canada. J Pain 2012;13:857–65.
. Stevens BJ, Yamada J, Estabrooks CA, Stinson J, Campbell F, Scott SD, Cummings G; CIHR Team in Children's Pain. Pain in hospitalized children: effect of a multidimensional knowledge translation strategy on pain process and clinical outcomes. PAIN 2014;155:60–8.
. Taddio A, Appleton M, Bortolussi R, Chambers C, Dubey V, Halperin S, Hanrahan A, Ipp M, Lockett D, MacDonald N, Midmer D, Mousmanis P, Palda V, Pielak K, Riddell RP, Rieder M, Scott J, Shah V. Reducing the pain of childhood vaccination
: an evidence-based clinical practice guideline. CMAJ 2010;182:E843–E855.
. Taddio A, Chambers CT, Halperin SA, Ipp M, Lockett D, Rieder MJ, Shah V. Inadequate pain management during routine childhood immunizations: the nerve of it. Clin Ther 2009;31(suppl 2):S152–S167.
. Taddio A, Ipp M, Thivakaran S, Jamal A, Parikh C, Smart S, Sovran J, Stephens D, Katz J. Survey of the prevalence of immunization non-compliance due to needle fears in children and adults. Vaccine 2012;30:4807–12.
. Taddio A, Katz J, Ilersich AL, Koren G. Effect of neonatal circumcision on pain response during subsequent routine vaccination
. Lancet 1997;349:599–603.
. Taddio A, McMurtry CM, Shah V, Riddell RP, Chambers CT, Noel M, MacDonald NE, Rogers J, Bucci LM, Mousmanis P, Lang E, Halperin SA, Bowles S, Halpert C, Ipp M, Asmundson GJ, Rieder MJ, Robson K, Uleryk E, Antony MM, Dubey V, Hanrahan A, Lockett D, Scott J, Votta Bleeker E; HELPinKids&Adults. Reducing pain during vaccine injections: clinical practice guideline. CMAJ 2015;187:975–82.
. Taddio A, Parikh C, Yoon EW, Sgro M, Singh H, Habtom E, Ilersich AF, Pillai Riddell R, Shah V. Impact of parent-directed education on parental use of pain treatments during routine infant vaccinations: a cluster randomized trial. PAIN 2015;156:185–91.
. Taddio A, Pillai Riddell R, Ipp M, Moss S, Baker S, Tolkin J, Malini D, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. Relative effectiveness of additive pain interventions during vaccination
in infants. CMAJ 2016;190:e227–e234.
. Taddio A, Shah V, McMurtry CM, MacDonald NE, Ipp M, Riddell RP, Noel M, Chambers CT; HELPinKids&Adults Team. Procedural and physical interventions for vaccine injections: systematic review of randomized controlled trials and quasi-randomized controlled trials. Clin J Pain 2015;31(10 suppl):S20–S37.
. Taylor EM, Boyer K, Campbell FA. Pain in hospitalized children: a prospective cross-sectional survey of pain prevalence, intensity, assessment and management in a Canadian pediatric teaching hospital. Pain Res Manag 2008;13:25–32.
. Treadwell MJ, Franck LS, Vichinsky E. Using quality improvement
strategies to enhance pediatric pain
assessment. Int J Qual Health Care 2002;14:39–47.
. Twycross A, Collis S. How well is acute pain in children managed? A snapshot in one English hospital. Pain Manag Nurs 2013;14:e204–e215.
. Twycross A, Dowden SJ. 2010 Do organizational quality improvement
strategies improve pain management? Pediatric Pain
Letter Special Interest Group on Pain in Childhood 2010;12:7–10.
. Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR. Psychological interventions for needle-related procedural pain
and distress in children and adolescents. Cochrane Database Syst Rev 2013:CD005179.
. Valeri BO, Ranger M, Chau CM, Cepeda IL, Synnes A, Linhares MB, Grunau RE. Neonatal invasive procedures predict pain intensity at school age in children born very preterm. Clin J Pain 2015.
. VitalSmarts. Children's Minnesota: using the influencer model to create a new standard of pediatric care. Provo, UT: VitalSmarts, 2018. YouTube. https://youtu.be/ZXKaLdMNDlc
. Walther-Larsen S, Pedersen MT, Friis SM, Aagaard GB, Romsing J, Jeppesen EM, Friedrichsdorf SJ. Pain prevalence in hospitalized children: a prospective cross-sectional survey in four Danish university hospitals. Acta Anaesthesiol Scand 2017;61:328–37.
. Watterberg KL, Cummings JJ, Benitz WE, Eichenwald EC, Poindexter BB, Stewart DL, Aucott SW, Goldsmith JP, Puopolo KM, Wang KS, Tobias JD, Agarwal R, Anderson CT, Hardy CA, Honkanen A, Rehman MA, Bannister CF. Prevention and management of procedural pain
in the neonate: an update. Pediatrics 2016;137:e20154271.
. Womack JP, Jone JT. Lean
thinking: Banish waste and create wealth in your corporation. United Kingdom: Simon and Schuster, 2003.
. Zhu LM, Stinson J, Palozzi L, Weingarten K, Hogan ME, Duong S, Carbajal R, Campbell FA, Taddio A. Improvements in pain outcomes in a Canadian pediatric teaching hospital following implementation of a multifaceted knowledge translation initiative. Pain Res Manag 2012;17:173–9.
. Zier JL, Liu M. Safety of high-concentration nitrous oxide by nasal mask for pediatric procedural sedation: experience with 7802 cases. Pediatr Emerg Care 2011;27:1107–12.