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. 2023 Aug 29;8(8):CD004950.
doi: 10.1002/14651858.CD004950.pub4.

Breastfeeding or breast milk for procedural pain in neonates

Prakeshkumar S Shah  1 , Ranjit Torgalkar  2 , Vibhuti S Shah  1
Affiliations

Breastfeeding or breast milk for procedural pain in neonates

Prakeshkumar S Shah et al. Cochrane Database Syst Rev. .

Abstract

Background: Pain in the neonate is associated with acute behavioural and physiological changes. Cumulative pain is associated with morbidities, including adverse neurodevelopmental outcomes. Studies have shown a reduction in changes in physiological parameters and pain score measurements following pre-emptive analgesic administration in neonates experiencing pain or stress. Non-pharmacological measures (such as holding, swaddling and breastfeeding) and pharmacological measures (such as acetaminophen, sucrose and opioids) have been used for analgesia. This is an update of a review first published in 2006 and updated in 2012.

Objectives: The primary objective was to evaluate the effectiveness of breastfeeding or supplemental breast milk in reducing procedural pain in neonates. The secondary objective was to conduct subgroup analyses based on the type of control intervention, gestational age and the amount of supplemental breast milk given.

Search methods: We searched CENTRAL, MEDLINE, Embase, CINAHL and trial registries (ICTRP, ISRCTN and clinicaltrials.gov) in August 2022; searches were limited from 2011 forwards. We checked the reference lists of included studies and relevant systematic reviews.

Selection criteria: We included randomised controlled trials (RCTs) or quasi-RCTs of breastfeeding or supplemental breast milk versus no treatment/other measures in neonates. We included both term (≥ 37 completed weeks postmenstrual age) and preterm infants (< 37 completed weeks' postmenstrual age) up to a maximum of 44 weeks' postmenstrual age. The study must have reported on either physiological markers of pain or validated pain scores.

Data collection and analysis: We assessed the methodological quality of the trials using the information provided in the studies and by personal communication with the authors. We extracted data on relevant outcomes, estimated the effect size and reported this as a mean difference (MD). We used the GRADE approach to assess the certainty of evidence.

Main results: Of the 66 included studies, 36 evaluated breastfeeding, 29 evaluated supplemental breast milk and one study compared them against each other. The procedures conducted in the studies were: heel lance (39), venipuncture (11), intramuscular vaccination (nine), eye examination for retinopathy of prematurity (four), suctioning (four) and adhesive tape removal as procedure (one). We noted marked heterogeneity in the control interventions and pain assessment measures amongst the studies. Since many studies included multiple arms with breastfeeding/supplemental breast milk as the main comparator, we were not able to synthesise all interventions together. Individual interventions are compared to breastfeeding/supplemental breast milk and reported. The numbers of studies/participants presented with the findings are not taken from pooled analyses (as is usual in Cochrane Reviews), but are the overall totals in each comparison. Overall, the included studies were at low risk of bias except for masking of intervention and outcome assessment, where nearly one-third of studies were at high risk of bias. Breastfeeding versus control Breastfeeding may reduce the increase in heart rate compared to holding by mother, skin-to-skin contact, bottle feeding mother's milk, moderate concentration of sucrose/glucose (20% to 33%) with skin-to-skin contact (low-certainty evidence, 8 studies, 784 participants). Breastfeeding likely reduces the duration of crying compared to no intervention, lying on table, rocking, heel warming, holding by mother, skin-to-skin contact, bottle feeding mother's milk and moderate concentration of glucose (moderate-certainty evidence, 16 studies, 1866 participants). Breastfeeding may reduce percentage time crying compared to holding by mother, skin-to-skin contact, bottle feeding mother's milk, moderate concentration sucrose and moderate concentration of sucrose with skin-to-skin contact (low-certainty evidence, 4 studies, 359 participants). Breastfeeding likely reduces the Neonatal Infant Pain Scale (NIPS) score compared to no intervention, holding by mother, heel warming, music, EMLA cream, moderate glucose concentration, swaddling, swaddling and holding (moderate-certainty evidence, 12 studies, 1432 participants). Breastfeeding may reduce the Neonatal Facial Coding System (NFCS) score compared to no intervention, holding, pacifier and moderate concentration of glucose (low-certainty evidence, 2 studies, 235 participants). Breastfeeding may reduce the Douleur Aigue Nouveau-né (DAN) score compared to positioning, holding or placebo (low-certainty evidence, 4 studies, 709 participants). In the majority of the other comparisons there was little or no difference between the breastfeeding and control group in any of the outcome measures. Supplemental breast milk versus control Supplemental breast milk may reduce the increase in heart rate compared to water or no intervention (low-certainty evidence, 5 studies, 336 participants). Supplemental breast milk likely reduces the duration of crying compared to positioning, massage or placebo (moderate-certainty evidence, 11 studies, 1283 participants). Supplemental breast milk results in little or no difference in percentage time crying compared to placebo or glycine (low-certainty evidence, 1 study, 70 participants). Supplemental breast milk results in little or no difference in NIPS score compared to no intervention, pacifier, moderate concentration of sucrose, eye drops, gentle touch and verbal comfort, and breast milk odour and verbal comfort (low-certainty evidence, 3 studies, 291 participants). Supplemental breast milk may reduce NFCS score compared to glycine (overall low-certainty evidence, 1 study, 40 participants). DAN scores were lower when compared to massage and water; no different when compared to no intervention, EMLA and moderate concentration of sucrose; and higher when compared to rocking or pacifier (low-certainty evidence, 2 studies, 224 participants). Due to the high number of comparator interventions, other measures of pain were assessed in a very small number of studies in both comparisons, rendering the evidence of low certainty. The majority of studies did not report on adverse events, considering the benign nature of the intervention. Those that reported on adverse events identified none in any participants. Subgroup analyses were not conducted due to the small number of studies.

Authors' conclusions: Moderate-/low-certainty evidence suggests that breastfeeding or supplemental breast milk may reduce pain in neonates undergoing painful procedures compared to no intervention/positioning/holding or placebo or non-pharmacological interventions. Low-certainty evidence suggests that moderate concentration (20% to 33%) glucose/sucrose may lead to little or no difference in reducing pain compared to breastfeeding. The effectiveness of breast milk for painful procedures should be studied in the preterm population, as there are currently a limited number of studies that have assessed its effectiveness in this population.

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Conflict of interest statement

PSS is an Associate Editor for Cochrane Neonatal; however, he was not involved in the editorial process for this review.

RT declares there is no conflict of interest.

VS is an Associate Editor for Cochrane Neonatal; however, she was not involved in the editorial process for this review.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Breastfeeding vs control, Outcome 1: Heart rate change (beats per minute)
1.2
1.2. Analysis
Comparison 1: Breastfeeding vs control, Outcome 2: Heart rate (beats per minute)
1.3
1.3. Analysis
Comparison 1: Breastfeeding vs control, Outcome 3: Oxygen saturation change
1.4
1.4. Analysis
Comparison 1: Breastfeeding vs control, Outcome 4: Oxygen saturation
1.5
1.5. Analysis
Comparison 1: Breastfeeding vs control, Outcome 5: Blood pressure changes (mmHg)
1.6
1.6. Analysis
Comparison 1: Breastfeeding vs control, Outcome 6: Systolic blood pressure change (mmHg)
1.7
1.7. Analysis
Comparison 1: Breastfeeding vs control, Outcome 7: Diastolic blood pressure change (mmHg)
1.8
1.8. Analysis
Comparison 1: Breastfeeding vs control, Outcome 8: Latency to first cry
1.9
1.9. Analysis
Comparison 1: Breastfeeding vs control, Outcome 9: Duration of first cry (seconds)
1.10
1.10. Analysis
Comparison 1: Breastfeeding vs control, Outcome 10: Duration of crying (seconds)
1.11
1.11. Analysis
Comparison 1: Breastfeeding vs control, Outcome 11: Percentage of time crying
1.12
1.12. Analysis
Comparison 1: Breastfeeding vs control, Outcome 12: Time to first calming (seconds)
1.13
1.13. Analysis
Comparison 1: Breastfeeding vs control, Outcome 13: Neonatal Infant Pain Scale (NIPS)
1.14
1.14. Analysis
Comparison 1: Breastfeeding vs control, Outcome 14: Premature Infant Pain Profile Score
1.15
1.15. Analysis
Comparison 1: Breastfeeding vs control, Outcome 15: Neonatal Facial Coding System (NFCS)
1.16
1.16. Analysis
Comparison 1: Breastfeeding vs control, Outcome 16: Douleur Aigue Nouveau‐né (DAN) Scale
1.17
1.17. Analysis
Comparison 1: Breastfeeding vs control, Outcome 17: COMFORTneo scale
1.18
1.18. Analysis
Comparison 1: Breastfeeding vs control, Outcome 18: Composite score
1.19
1.19. Analysis
Comparison 1: Breastfeeding vs control, Outcome 19: ALPS‐Neo scale
2.1
2.1. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 1: Heart rate change (beats per minute)
2.2
2.2. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 2: Heart rate (beats per minute)
2.3
2.3. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 3: Oxygen saturation change
2.4
2.4. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 4: Oxygen saturations
2.5
2.5. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 5: Respiratory rate
2.6
2.6. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 6: Systolic blood pressure
2.7
2.7. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 7: Diastolic blood pressure
2.8
2.8. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 8: Duration of first cry (seconds)
2.9
2.9. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 9: Duration of crying (seconds)
2.10
2.10. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 10: Percentage of time crying
2.11
2.11. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 11: Neonatal Infant pain scale (NIPS)
2.12
2.12. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 12: Premature infant pain profile (PIPP)
2.13
2.13. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 13: Neonatal Facial Coding System score at 3 minutes
2.14
2.14. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 14: Neonatal Facial Coding System score at 2 minutes
2.15
2.15. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 15: Douleur Aigue du Nouveau‐né (DAN) scale
2.16
2.16. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 16: Body pain score
2.17
2.17. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 17: Neonatal Pain, Agitation and Sedation Scale (N‐PASS)
2.18
2.18. Analysis
Comparison 2: Supplemental breast milk vs control, Outcome 18: Premature Infant Pain Profile ‐ Revised scale
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References

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    1. Sahoo JP, Rao S, Nesargi S, Ranjit T, Ashok C, Bhat S. Expressed breast milk vs 25% dextrose in procedural pain in neonates, a double blind randomized controlled trial. Indian Pediatrics 2013;50(2):203-7. [DOI: 10.1007/s13312-013-0067-3] [PMID: ] - DOI - PubMed
Shendurnikar 2005 (Heel lance) {published and unpublished data}
    1. Shendurnikar N, Gandhi K. Analgesic effects of breastfeeding on heel lancing. Indian Pediatrics 2005;42(7):730-2. [PMID: ] - PubMed
Simonse 2012 (Heel lance) {published data only}
    1. Simonse E, Mulder PG, Beek RH. Analgesic effect of breast milk versus sucrose for analgesia during heel lance in late preterm infants. Pediatrics 2012;129(4):657-63. [DOI: 10.1542/peds.2011-2173] [PMID: ] - DOI - PubMed
Singh 2017 (Heel lance) {published data only}
    1. Singh RK, Simalti A, Singh D. Breast feeding as analgesia in neonates: a randomized controlled trial. Journal of Nepal Paediatric Society 2017;36(3):238-42. [DOI: 10.3126/jnps.v36i3.15688] - DOI
Skogsdal 1997 (Heel lance) {published and unpublished data}
    1. Skogsdal Y, Eriksson M, Schollin J. Analgesia in newborns given oral glucose. Acta Paediatrica 1997;86(2):217-20. [DOI: 10.1111/j.1651-2227.1997.tb08872.x] [PMID: ] - DOI - PubMed
Soltani 2018 (Heel lance) {published data only}
    1. Soltani S, Zohoori D, Adineh M. Comparison the effectiveness of breastfeeding, oral 25% dextrose, kangaroo-mother care method, and EMLA cream on pain score level following heal pick sampling in newborns: a randomized clinical trial. Electronic Physician 2018;10(5):6741-8. [DOI: 10.19082/6741] [PMID: ] - DOI - PMC - PubMed
Sujatha 2018 (Intradermal) {published data only}
    1. Sujatha S, Samson R, Sundaresan. Breast milk for neonatal vaccination pain. Nursing Journal of India 2018;109(6):248. [DOI: 10.22376/IJPBS.2017.8.2.B949-955] - DOI
Taplak 2017 (Eye examination) {published data only}
    1. Şener Taplak A, Erdem E. A comparison of breast milk and sucrose in reducing neonatal pain during eye exam for retinopathy of prematurity. Breastfeeding Medicine 2017;12(5):305-10. [DOI: 10.1089/bfm.2016.0122] [PMID: ] - DOI - PubMed
Tavlar 2021 (Heel lance) {published data only}
    1. Tavlar M, Karakoc A. The effect of breastfeeding, breast milk odour and mother's heartbeat sound on pain level in newborns: a randomized trial. International Journal of Nursing Practice 2022;28(6):e13067. [DOI: 10.1111/ijn.13067] [PMID: ] - DOI - PubMed
Turan 2021 (Eye examination) {published data only}
    1. Turan O, Akkoyun I, Ince DA, Doganay B, Tugcu AU, Ecevit A. Effect of breast milk and sucrose on pain and perfusion index during examination for retinopathy of prematurity. Journal of Maternal-Fetal & Neonatal Medicine 2021;34(7):1138-42. [DOI: 10.1080/14767058.2019.1628209] [PMID: ] - DOI - PubMed
Upadhyay 2004 (Venipuncture) {published data only}
    1. Upadhyay A, Aggarwal R, Narayan S, Joshi M, Paul VK, Deorari AK. Analgesic effect of expressed breast milk in procedural pain in term neonates: a randomized, placebo-controlled, double-blind trial. Acta Paediatrica 2004;93(4):518-22. [DOI: 10.1080/08035250410022792] [PMID: ] - DOI - PubMed
Uyan 2005 (Heel lance) {published data only}
    1. Uyan ZS, Ozek E, Bilgen H, Cebeci D, Akman I. Effect of foremilk and hindmilk on simple procedural pain in newborns. Pediatrics International 2005;47(3):252-7. [DOI: 10.1111/j.1442-200x.2005.02055.x] [PMID: ] - DOI - PubMed
Velumula 2022 (Heel lance) {published data only}
    1. Velumula PK, Elbakoush F, Tabb C 2nd, Farooqi A, Lulic-Botica M, Jani S, et al. Breast milk vs 24% sucrose for procedural pain relief in preterm neonates: a non-inferiority randomized controlled trial. Journal of Perinatology 2022;42(7):914-9. [DOI: 10.1038/s41372-022-01352-2] [PMID: ] - DOI - PubMed
Weissman 2009 (Heel lance) {published data only}
    1. Weissman A, Aranovitch M, Blazer S, Zimmer EZ. Heel-lancing in newborns: behavioral and spectral analysis assessment of pain control methods. Pediatrics 2009;124(5):e921-6. [DOI: 10.1542/peds.2009-0598] [PMID: ] - DOI - PubMed
Wu 2021 (Heel lance) {published data only}
    1. Wu H, Zhang J, Ding Q, Wang S, Li J. Effect analysis of embracing breast milk sucking to relieve pain of neonatal heel blood sampling: a randomized controlled trial. Annals of Palliative Medicine 2021;10(4):4384-90. [DOI: 10.21037/apm-21-329] [PMID: ] - DOI - PubMed
Yilmaz 2011 (Heel lance) {published data only}
    1. Yilmaz F, Arikan D. The effects of various interventions to newborns on pain and duration of crying. Journal of Clinical Nursing 2011;20:1008-17. [DOI: 10.1111/j.1365-2702.2010.03356.x] [PMID: ] - DOI - PubMed
Yilmaz 2020 (Heel lance) {published data only}
    1. Yilmaz D, Inal S. Effects of three different methods used during heel lance procedures on pain level in term neonates. Japan Journal of Nursing Science 2020;17(4):e12338. [DOI: 10.1111/jjns.12338] [PMID: ] - DOI - PubMed
Zargham‐Boroujeni 2017 (Venipuncture) {published data only}
    1. Zargham-Boroujeni A, Elsagh A, Mohammadizadeh M. The effects of massage and breastfeeding on response to venipuncture pain among hospitalized neonates. Iranian Journal of Nursing and Midwifery Research 2017;22(4):308-12. [DOI: 10.4103/ijnmr.IJNMR_119_13] [PMID: ] - DOI - PMC - PubMed
Zhu 2015 (Heel lance) {published data only}
    1. Zhu J, Hong-Gu H, Zhou X, Wei H, Gao Y, Ye B, et al. Pain relief effect of breast feeding and music therapy during heel lance for healthy-term neonates in China: a randomized controlled trial. Midwifery 2015;31(3):365-72. [DOI: 10.1016/j.midw.2014.11.001] [PMID: ] - DOI - PubMed

References to studies excluded from this review

Bilgen 2001 {published data only}
    1. Bilgen H, Ozek E, Cebeci D, Ors R. Comparison of sucrose, expressed breast milk, and breast-feeding on the neonatal response to heel prick. Journal of Pain 2001;2(5):301-5 (Retracted J Pain. 2003 Sep;4(7):415). [DOI: 10.1054/jpai.2001.23140.] [PMID: ] - DOI - PubMed
Cirik 2020 {published data only}
    1. Cirik VA, Efe E. The effect of expressed breast milk, swaddling and facilitated tucking methods in reducing the pain caused by orogastric tube insertion in preterm infants: a randomized controlled trial. International Journal of Nursing Studies 2020;104:103532. [DOI: 10.1016/j.ijnurstu.2020.103532] [PMID: ] - DOI - PubMed
Efe 2007a {published data only}
    1. Efe E, Ozer ZC. The use of breast-feeding for pain relief during neonatal immunization injections. Applied Nursing Research 2007;20(1):10-6. [DOI: 10.1016/j.apnr.2005.10.005] [PMID: ] - DOI - PubMed
Erkul 2017 {published data only}
    1. Erkul M, Efe E. Efficacy of breastfeeding on babies' pain during vaccinations. Breastfeeding Medicine 2017;12:110-15. [DOI: 10.1089/bfm.2016.0141] [PMID: ] - DOI - PubMed
Hsieh 2018 {published data only}
    1. Hsieh KH, Chen SJ, Tsao PC, Wang CC, Huang CF, Lin CM, et al. The analgesic effect of non-pharmacological interventions to reduce procedural pain in preterm neonates. Pediatrics & Neonatology 2018;59(1):71-6. [DOI: 10.1016/j.pedneo.2017.02.001] [PMID: ] - DOI - PubMed
Iturriaga 2009 {published data only}
    1. Iturriaga GS, Unceta-Barrenechea AA, Zárate KS, Olaechea IZ, Núñez AR, Rivero MM. Analgesic effect of breastfeeding when taking blood by heel-prick in newborns [Efecto analgesico de la lactancia materna en la toma sanguinea del talón en el recien nacido]. Anales de Pediatria 2009;71(4):310-3. [DOI: 10.1016/j.anpedi.2009.06.023] [PMID: ] - DOI - PubMed
Osinaike 2007 {published data only}
    1. Osinaike BB, Oyedeji AO, Adeoye OT, Dairo MD, Aderinto DA. Effect of breastfeeding during venepuncture in neonates. Annals of Tropical Paediatrics 2007;27(3):201-5. [DOI: 10.1179/146532807X220316] [PMID: ] - DOI - PubMed
Shukla 2018 {published data only}
    1. Shukla VV, Bansal S, Nimbalkar A, Chapla A, Phatak A, Patel D, et al. Pain control interventions in preterm neonates: a randomized controlled trial. Indian Pediatrics 2018;55(4):292-6. [PMID: ] - PubMed
Wu 2020 {published data only}
    1. Wu HP, Yin T, Hsieh KH, Lan HY, Feng RC, Chang YC, et al. Integration of different sensory interventions from mother's breast milk for preterm infant pain during peripheral venipuncture procedures: a prospective randomized controlled trial. Journal of Nursing Scholarship 2020;52(1):75-84. [DOI: 10.1111/jnu.12530] [PMID: ] - DOI - PubMed

References to ongoing studies

NCT00908401 {unpublished data only}
    1. NCT00908401. Analgesic effect of breastmilk for procedural pain in preterm infants (BMoS). clinicaltrials.gov/ct2/show/NCT00908401 (first received 25 May 2009).
NCT01355640 {unpublished data only}
    1. NCT01355640. Two methods of analgesia for Chinese term infants receiving heel lance. clinicaltrials.gov/ct2/show/NCT01355640 (first received 18 May 2011).

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References to other published versions of this review

Aliwalas 2004
    1. Aliwalas LL, Shah V, Shah PS. Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database of Systematic Reviews 2004, Issue 4. Art. No: CD004950. [DOI: 10.1002/14651858.CD004950] - DOI - PMC - PubMed
Shah 2006
    1. Shah PS, Aliwalas L, Shah V. Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database of Systematic Reviews 2006, Issue 3. Art. No: CD004950. [DOI: 10.1002/14651858.CD004950.pub2] - DOI - PubMed
Shah 2012
    1. Shah PS, Herbozo C, Aliwalas LL, Shah VS. Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database of Systematic Reviews 2012, Issue 12. Art. No: CD004950. [DOI: 10.1002/14651858.CD004950.pub3] - DOI - PMC - PubMed

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