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BMC Pediatrics

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Open Access 01-12-2017 | Study protocol

Individual contextual factors in the validation of the Bernese pain scale for neonates: protocol for a prospective observational study

Authors: Eva Cignacco, Karin Schenk, Bonnie Stevens, Liliane Stoffel, Dirk Bassler, Sven Schulzke, Mathias Nelle

Published in: BMC Pediatrics | Issue 1/2017

Abstract

Background

The Bernese Pain Scale for Neonates (BPSN) is a multidimensional pain assessment tool that is already widely used in clinical settings in the German speaking areas of Europe. Recent findings indicate that pain responses in preterm neonates are influenced by individual contextual factors, such as gestational age (GA), gender and the number of painful procedures experienced. Currently, the BPSN does not consider individual contextual factors. Therefore, the aim of this study is the validation of the BPSN using a large sample of neonates with different GAs. Furthermore, the influence of individual contextual factors on the variability in pain reactions across GA groups will be explored. The results will be used for a modification of the BPSN to account for individual contextual factors in future clinical pain assessment in neonates.

Methods and design

This prospective multisite validation study with a repeated measures design will take place in three university hospital neonatal intensive care units (NICUs) in Switzerland (Bern, Basel and Zurich). To examine the impact of GA on pain responses and their variability, the infants will be stratified into six GA groups ranging from 24 0/7 to 42 0/7. Among preterm infants, 2–5 routine capillary heel sticks within the first 14 days of life, and among full-term infants, two heel sticks during the first days of life will be documented. For each heel stick, measurements will be video recorded for each of three phases: baseline, heel stick, and recovery. The infants’ pain responses will be rated according to the BPSN by five nurses who are blinded as to the number of each heel stick and as to the measurement phases. Individual contextual factors of interest will be extracted from patient charts.

Discussion

Understanding and considering the influence of individual contextual factors on pain responses in a revised version of the BPSN will help the clinical staff to more appropriately assess pain in neonates, particularly preterm neonates hospitalized in NICUs. Pain assessment is a first step toward appropriate and efficient pain management, which itself is an important factor in later motor and cognitive development in this vulnerable patient population.

Trial registration

The study is registered in the database of Clinical Trial gov. Study ID-number: NCT 02749461. Registration date: 12 April 2016.

Carbajal R, Rousset A, Danan C, Coquery S, Nolent P, Ducrocq S, et al. Epidemiology and treatment of painful procedures in neonates in intensive care units. JAMA. 2008;300(1):60–70.CrossRefPubMed

Cignacco E, Hamers J, van Lingen RA, Stoffel L, Büchi S, Müller R, et al. Neonatal procedural pain exposure and pain management in ventilated preterm infants during the first 14 days of life. Swiss Med Wkly. 2009;139(15–16):226–32.PubMed

Johnston C, Barrington KJ, Taddio A, Carbajal R, Filion F. Pain in Canadian NICUs: have we improved over the past 12 years? Clin J Pain. 2011;27(3):225–32.CrossRefPubMed

Amercian Academy of Pediatrics, Committee on Fetus and Newborn, Section on Anesthesiology and Pain Medicine. Prevention and Management of Procedural Pain in the Neonate: An Update. Pediatrics. 2016;137(2):e20154271.

Amercian Academy of Pediatrics, Committee on Fetus and Newborn, Section on Surgery, and Section on Anesthesiology and Pain Medicine, Canadian Paediatric Society, Fetus and Newborn Committee. Prevention and Management of Pain in the neonate: an update. Pediatrics. 2006;118(5):2231–41.CrossRef

Bhutta AT, Anand KJS. Vulnerability of the developing brain: neuronal mechanisms. Clin Perinatol. 2002;29:357–72.CrossRefPubMed

Brummelte S, Grunau RE, Chau V, Poskitt KJ, Brant R, Vinall J, et al. Procedural pain and brain development in premature newborns. Ann Neurol. 2012;71(3):385–96. doi:10.1002/ana.22267.CrossRefPubMedPubMedCentral

Anand KJ, Carr DB. The neuroanatomy, neurophysiology, and neurochemistry of pain, stress, and analgesia in newborns and children. Pediatr Clin N Am. 1989;36(4):795–822.CrossRef

Anand KJS, Scalzo FM. Can adverse neonatal experiences Alter brain development and subsequent behavior? Biol Neonate. 2000;77(2):69–82.CrossRefPubMed

10.

Zwicker JG, Grunau RE, Adams E, Chau V, Brant R, Poskitt KJ, et al. Score for neonatal acute physiology-II and neonatal pain predict corticospinal tract development in premature newborns. Pediatr Neurol. 2013;48:123–9.CrossRefPubMedPubMedCentral

11.

Smith GC, Gutovich J, Smyser C, Pineda R, Newnham C, Tjoeng TH, et al. NICU stress is Asscociated with brain development in preterm infants. Ann Neurol. 2011;70(4):541–9. doi:10.1002/ana.22545.CrossRefPubMedPubMedCentral

12.

Ranger M, Grunau RE. Early repetitive pain in preterm infants in relation to the developing brain. Pain Management. 2014;4(1):57–67. doi:10.2217/pmt.13.61.CrossRefPubMedPubMedCentral

13.

Vinall J, Grunau RE. Impact of repeated procedural pain-related stress in infants born very preterm. Pediatr Res. 2014;75(5):584–7. doi:10.1038/pr.2014.16.CrossRefPubMedPubMedCentral

14.

Taddio A, Katz J. The effects of early pain experience in neonates on pain responses in infancy and childhood. Paediatric Drugs. 2005;7(4):245–57.CrossRefPubMed

15.

Taddio A, Shah V, Gilbert-MacLeod C, Katz J. Conditioning and hyperalgesia in newborns exposed to repeated heel lances. JAMA. 2002;288(7):857–61.CrossRefPubMed

16.

Hermann C, Hohmeister J, Demirakca S, Zohsel K, Flor H. Long-term alteration of pain sensitivity in school-aged children with early pain experiences. Pain. 2006;125:278–85.CrossRefPubMed

17.

Vinall J, Miller SP, Bjornson BH, Fitzpatrick KPV, Poskitt KJ, Brant R, et al. Invasive procedures in preterm children: brain and cognitive development at school age. Pediatrics. 2014;133(3):412–21. doi:10.1542/peds.2013-1863.CrossRefPubMedPubMedCentral

18.

Doesburg SM, Chau CM, Cheung TPL, Moiseev A, Ribary U, Herdman AT, et al. Neonatal pain-related stress, functional cortical activity and visual-perceptual abilities in school-age children born at extremely low gestational age. Pain. 2013;154(10):1946–52. doi:10.1016/j.pain.2013.04.009.CrossRefPubMedPubMedCentral

19.

Grunau RE, Whitfield MF, Petrie-Thomas J, Synnes AR, Cepeda IL, Keidar A, et al. Neonatal pain, parenting stress and interaction, in relation to cognitive and motor development at 8 and 18 months in preterm infants. Pain. 2009;143(1–2):138–46. doi:10.1016/j.pain.2009.02.014.CrossRefPubMedPubMedCentral

20.

Aarnoudse-Moens GSH, Weisglas-Kuperus N, van Goudoever JB, Oosterlaan J. Meta-analysis of neurobehavioral outcomes in very preterm and/or very low birth weight children. Pediatrics. 2009;124(2):717–28.CrossRefPubMed

21.

Grunau RE. Neonatal pain in very preterm infants: long-term effects on brain, neurodevelopment and pain reactivity. Rambam Maimonides medical journal. 2013;4:e0025.PubMedPubMedCentral

22.

Ranger M, Chau CMY, Garg A, Woodward TS, Beg MF, Bjornson B, et al. Neonatal pain-related stress predicts cortical thickness at age 7 years in children born very preterm. PLoS One. 2013;8(10):e76702. doi:10.1371/journal.pone.0076702.CrossRefPubMedPubMedCentral

23.

Lee GY, Stevens BJ. Neonatal and infant pain assessment. In: McGrath PJ, Stevens BJ, Walker SM, Zempsky WT, editors. Oxford textbook of Paediatric pain. Oxford: Oxford University Press; 2014. p. 353–69.

24.

Stevens BJ, Pillai Ridell RR, Oberlander TE, Gibbins S. Assessment of pain in neonates and infants. In: Anand KJS, Stevens BJ, McGrath PJ, editors. Pain in neonates and infants. 3rd ed. Edinburgh: Elsevier; 2007. p. 67–90.

25.

Cong X, McGrath JM, Cusson RM, Zhang D. Pain assessment and measurement in neonates: an updated review. Advances in Neonatal Care. 2013;13(6):379–95.CrossRefPubMed

26.

Stevens BJ, Gibbins S, Yamada RN, Dionne K, Lee G, Johnston C, et al. The premature infant pain profile-revised (PIPP-R) initial validation and feasibility. Clin J Pain. 2014;30(3):238–43.CrossRefPubMed

27.

Brummelte S, Oberlander TF, Craig KD. Biomarkers of pain: physiological indices of pain reactivity in infants and children. In: McGrath PJ, Stevens BJ, Walker SM, Zempsky WT, editors. Oxford textbook of Paediatric pain. Oxford: Oxford University Press; 2014. p. 391–400.

28.

Maimon N, Grunau RE, Cepeda IL, Friger M, Selnovik L, Gilat S, et al. Electroencephalographic activity in response to procedural pain in preterm infants born at 28 and 33 weeks gestational age. Clin J Pain. 2013;29(12):1044–9.CrossRefPubMed

29.

Slater R, Fabrizi L, Worley A, Meek J, Boyd S, Fitzgerald M. Premature infants display increased noxious-evoked neuronal activity in the brain compared to healthy age-matched term-born infants. NeuroImage. 2010;52:583–9.CrossRefPubMed

30.

Williams G, Fabrizi L, Meek J, Jackson D, Tracey I, Robertson N, et al. Functional magnetic resonance imaging can be used to explore tactile and nociceptive processing in the infant brain. Acta Paediatr. 2015;104:158–66.CrossRefPubMed

31.

Ranger M, Grunau RE. How do babies feel pain? elife. 2015;4:e07552.CrossRefPubMedPubMedCentral

32.

Fitzgerald M. What do we really know about newborn infant pain? Exp Physiol. 2015;100(12):1451–7.CrossRefPubMed

33.

Holsti L, Grunau RE, Shany E. Assessing pain in preterm infants in the neonatal intensive care unit: moving to a 'brain-oriented' approach. Pain management. 2011;1(2):171–9. doi:10.2217/pmt.10.19.CrossRefPubMedPubMedCentral

34.

Slater R, Cantarella A, Franck L, Meek J, Fitzgerald M. How well do clinical pain assessment tools reflect pain in infants? PLoS Med. 2008;5(6):e129.CrossRefPubMedPubMedCentral

35.

Lucas-Thompson R, Townsend EL, Gunnar MR, Georgieff MK, Guiang SF, Ciffuentes RF, et al. Developmental changes in the responses of preterm infants to a painful stressor. Infant Behav Dev. 2008;31(4):614–23. doi:10.1016/j.infbeh.2008.07.004.CrossRefPubMedPubMedCentral

36.

Pillai Riddell R, Fitzgerald M, Slater R, Stevens B, Johnston C, Campbell-Yeo M. Using only behaviours to assess infant pain: a painful compromise? Pain. 2016;157(8):1579–80.CrossRefPubMed

37.

Maxwell LG, Malavolta CP, Fraga MV. Assessment of pain in the neonate. Clin Perinatol. 2013;40(3):457–69.CrossRefPubMed

38.

Franck LS, Bruce E. Putting pain assessment into practice: why is it so painful? Pain Research and Management. 2009;14(1):13–20.CrossRefPubMedPubMedCentral

39.

Badr LK. Pain in premature infants: what is conclusive evidence and what is not. Newborn & Infant Nursing Reviews. 2013;13:82–6.CrossRef

40.

Sellam G, Engberg S, Denhaerynck K, Craig KD, Cignacco EL. Contextual factors associated with pain response of preterm infants to heel-stick procedures. Eur J Pain. 2013;17:255–63.CrossRefPubMed

41.

Cignacco E, Mueller R, Hamers JPH, Gessler P. Pain assessment in the neonates using the Bernese pain scale for neonates. Early Hum Dev. 2004;78:125–31.CrossRefPubMed

42.

Cignacco E, Denhaerynck K, Nelle M, Bührer C, Engberg S. Variability in pain response to a non-pharmacological intervention across repeated routine pain exposure in preterm infants: a feasibility study. Acta Paediatr. 2009;98(5):842–6.CrossRefPubMed

43.

Johnston CC, Stevens BJ, Franck LS, Jack A, Stremler R, Platt R. Factors explaining lack of response to heel stick in preterm newborns. JOGNN. 1999;28(7):587–94.CrossRefPubMed

44.

Sellam G, Cignacco EL, Craig KD, Engberg S. Contextual factors influencing pain response to heelstick procedures in preterm infants: What do we know? A systematic review. Eur J Pain. 2011;15:661.e1–661.e15.

45.

Craig KD, Whitfield MF, Grunau RVE, Linton J, Hadjistavropoulos HD. Pain in the preterm neonate: behavioural and physiological indices. Pain. 1993;52:287–99.CrossRefPubMed

46.

Johnston CC, Stevens B. Experience in a neonatal intensive care unit affects pain response. Pediatrics. 1996;98:925–30.PubMed

47.

Andrews K, Fitzgerald M. The cutaneous withdrawal reflex in human neonates: sensitization, receptive fields, and the effects of contralateral stimualtion. Pain. 1994;56:95–101.CrossRefPubMed

48.

Johnston CC, Fernandes AM, Campbell-Yeo M. Pain in neonates is different. Pain. 2011;152(3):S65–73.CrossRefPubMed

49.

Fitzgerald M. The development of nociceptive circuits. Nat Rev Neurosci. 2005;6(7):507–20.CrossRefPubMed

50.

Beggs S, Fitzgerald M. Development of peripheral and spinal nociceptive systems. In: KJS A, Stevens BJ, PJ MG, editors. Pain in Neonates and Infants. 3rd ed. Edinburgh: Elsevier; 2007. p. 11–24.

51.

Johnston CC, Stevens BJ, Yang F, Horton L. Differential response to pain by very premature neonates. Pain. 1995;61(3):471–9.CrossRefPubMed

52.

Morison SJ, Holsti L, Grunau RE, Whitfield MF, Oberlander TF, Chan HWP, et al. Are there developmentally distinct motor indicators of pain in preterm infants? Early Hum Dev. 2003;72:131–46.CrossRefPubMed

53.

Gibbins S, Stevens B. The influence of gestational age on the efficacy and short-term safety of sucrose for procedural pain relief. Advances in Neonatal Care. 2003;3(5):241–9.PubMed

54.

Gibbins S, Stevens B, McGrath PJ, Yamada J, Beyene J, Breau L, et al. Comparison of pain responses in infants of different gestational ages. Neonatology. 2008;93:10–8.CrossRefPubMed

55.

Slater R, Cantarella A, Yoxen J, Patten D, Potts H, Meek J, et al. Latency to facial expression change following noxious stimulation in infants is dependent on postmenstrual age. Pain. 2009;146:177–82.CrossRefPubMed

56.

Gibbins S, Stevens B, Beyene J, Chan PC, Bagg M, Asztalos E. Pain behaviours in extremely low gestational age infants. Early Hum Dev. 2008;84:451–8.CrossRefPubMed

57.

Holsti L, Grunau RE. Initial validation of the behavioral indicators of infant pain (BIIP). Pain. 2007;132(3):264–72.CrossRefPubMedPubMedCentral

58.

Holsti L, Grunau RE, Oberlander TF, Whitfield MF. Specific newborn individualized developmental care and assessment program movements are associated with acute pain in preterm infants in the neonatal intensive care unit. Pediatrics. 2004;114(1):65–72.CrossRefPubMedPubMedCentral

59.

Grunau RE, Oberlander TF, Whitfield MF, Fitzgerald C, Lee SK. Demographic and therapeutic determinants of pain reactivity in very low birth weight neonates at 32 Weeks' postconceptional age. Pediatrics. 2001;107(1):105–12.CrossRefPubMed

60.

Als H, Lawhon G, Brown E, Gibes R, Duffy FH, McAnulty G, et al. Individualized behavioral and environmental care for the very low birth weight preterm infant at high risk for bronchopulmonary dysplasia: neonatal intensive care unit and developmental outcome. Pediatrics. 1986;78:1123–32.PubMed

61.

Als H, Lawhon G, Duffy FH. Individualized developmental Care for the Very low-Birth-Weight Preterm Infant. JAMA. 1994;272(11):853–8.CrossRefPubMed

62.

Fitzgerald C, Millard C, McIntosh N. Cutaneous hypersensitivity following peripheral tissue damage in newborn infants and its reversal with topical anaesthesia. Pain. 1989;39(1):31–6.CrossRefPubMed

63.

Grunau RE, Holsti L, Haley DW, Oberlander T, Weinberg J, Solimano A, et al. Neonatal procedural pain exposure predicts lower cortisol and behavioral reactivity in preterm infants in the NICU. Pain. 2005;113(3):293–300.CrossRefPubMedPubMedCentral

64.

Evans JC, McCartney EM, Lawhon G, Galloway J. Longitudinal comparison of preterm pain responses to repeated heelsticks. Pediatr Nurs. 2005;31:216–21.PubMed

65.

Badr LK, Abdallah B, Hawari M, Sidani S, Kassar M, Nakad P, et al. Determinants of premature infant pain responses to heel sticks. Pediatr Nurs. 2010;36:129–36.PubMed

66.

Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2016;7 doi:10.1002/14651858.CD001069.pub.5.

67.

Bührer C, Grimmer I, Metze B, Obladen M. The CRIB (clinical risk index for babies) score and neurodevelopmental impairment at one year corrected age in very low birth weight infants. Intensive Care Med. 2000;26(3):325–9.CrossRefPubMed

68.

Cignacco E, Hamers J, Stoffel L, Van Lingen RA, Schütz N, Müller R, et al. Routine procedures in NICUs: factors influencing pain assessment and ranking by pain intensity. Swiss Med Wkly. 2008;138:484–91.PubMed

69.

Cignacco EL, Sellam G, Stoffel L, Gerull R, Nelle M, Anand KJS, et al. Oral sucrose and "facilitated tucking" for repeated pain relief in Preterms: a randomized controlled trial. Pediatrics. 2012;129(2):299–308.CrossRefPubMed

Title: Individual contextual factors in the validation of the Bernese pain scale for neonates: protocol for a prospective observational study
Authors: Eva Cignacco
Karin Schenk
Bonnie Stevens
Liliane Stoffel
Dirk Bassler
Sven Schulzke
Mathias Nelle
Publication date: 01-12-2017
Publisher: BioMed Central
Published in: BMC Pediatrics / Issue 1/2017
Electronic ISSN: 1471-2431
DOI: https://doi.org/10.1186/s12887-017-0914-9

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Individual contextual factors in the validation of the Bernese pain scale for neonates: protocol for a prospective observational study

Abstract

Background

Methods and design

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods and design

Discussion

Trial registration

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