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Guideline Summary
Guideline Title
Non-pharmacologic management of procedure-related pain in the breastfeeding infant.
Bibliographic Source(s)
Academy of Breastfeeding Medicine Protocol Committee. ABM clinical protocol #23: Non-pharmacologic management of procedure-related pain in the breastfeeding infant. Breastfeed Med. 2010 Dec;5(6):315-9. [59 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

Academy of Breastfeeding Medicine (ABM) protocols expire 5 years from the date of publication. Evidence-based revisions are made within 5 years or sooner if there are significant changes in the evidence.

Scope

Disease/Condition(s)

Procedure-related pain

Guideline Category
Counseling
Management
Clinical Specialty
Family Practice
Nursing
Nutrition
Obstetrics and Gynecology
Pediatrics
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Nurses
Physician Assistants
Physicians
Guideline Objective(s)
  • To provide healthcare professionals with evidence-based guidelines on how to incorporate non-pharmacologic or behavioral interventions to relieve procedure-induced pain in the breastfeeding infant
  • To develop clinical protocols for managing common medical problems that may impact breastfeeding success
Target Population

Newborns and young infants

Interventions and Practices Considered

Management

  1. Soothing the newborn
    • Breastfeeding or human milk
    • Skin-to-skin contact
    • Sucrose (or glucose) and sucking (in combination or separately)
      • Sucrose and pacifier
      • Sucrose by syringe
      • Pacifier alone
  2. Soothing the premature newborn
    • Skin-to-skin contact
    • A pacifier dipped in sucrose or in water
    • Breastfeeding (not established as pain reducer in premature newborns)
    • Skin-to-skin contact plus sucrose
  3. Soothing the older infant
    • Sucrose
    • Maternal/caretaker behavior
    • Breastfeeding
Major Outcomes Considered
  • Pain reduction
  • Reduction of infants' cry time, recovery time, and change in heart rate

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

An initial search of relevant published articles written in English in the past 20 years in the fields of medicine, psychiatry, psychology, and basic biological science was undertaken for a particular topic. Once the articles are gathered, the papers are evaluated for scientific accuracy and significance. In addition, older sentinel articles were included.

The databases searched included: PubMed, Ovid, and the National Institute of Child Health and Human Development (NICHD) Early Child Care Research Network. The search terms included: affect dysregulation in the mother–child relationship in the toddler years; antecedents and consequences; breastfeeding; lactation; pain; pain management; treatment of pain in infants; and non-pharmacologic pain management.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus (Committee)
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Levels of Evidence

I Evidence obtained from at least one properly randomized controlled trial.

II-1 Evidence obtained from well-designed controlled trials without randomization.

II-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.

II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence.

III Opinions of respected authorities, based on clinical experience, descriptive studies and case reports; or reports of expert committees.

Methods Used to Analyze the Evidence
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

An expert panel is identified and appointed to develop a draft protocol using evidence based methodology. An annotated bibliography (literature review), including salient gaps in the literature, are submitted by the expert panel to the Protocol Committee.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Not stated

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

The draft protocol is peer reviewed by individuals outside of contributing author/expert panel, including specific review for international applicability. The Protocol Committee's sub-group of international experts recommends appropriate international reviewers. The Chair and/or protocol resource person institutes and facilitates this process. Reviews are submitted to the committee Chair and resource person.

The contributing author/expert panel and/or designated members of protocol committee work to amend the protocol as needed.

The draft protocol is submitted to the Academy of Breastfeeding Medicine (ABM) Board for review and approval. Comments for revision will be accepted for three weeks following submission. The Chair, resource person and protocol contributor(s) amend the protocol as needed.

Following all revisions, the protocol has the final review by original contributor(s) to make final suggestions and ascertain whether to maintain contributing authorship.

The final protocol is submitted to the Board of Directors of ABM for approval. A two-thirds majority of Board members' positive vote is required for final approval.

Recommendations

Major Recommendations

Soothing the Newborn

There are several techniques that have been shown to provide pain relief for newborns (0–28 days of age) undergoing painful procedures. In breastfed newborns, breastfeeding itself is the preferred method to alleviate procedural pain. In addition to being safe, effective, natural, and without added cost, it provides an additional opportunity to promote and support breastfeeding. The individual components of breastfeeding (sucking, sweet taste, and warm contact) may be used separately or, preferably, in combinations when breastfeeding itself is not possible.

Breastfeeding or Human Milk

  1. When available, breastfeeding should be the first choice to alleviate procedural pain in neonates undergoing a single painful procedure, such as venipuncture or heel lance (Codipietro, Ceccarelli, & Ponzone, 2008; Carbajal et al., 2003; Gray et al., 2002). Breastfeeding should not be discontinued prior to the procedure. Studies show that when breastfeeding was stopped shortly before a painful procedure, no significant differences were found (compared to control groups) in outcomes in terms of the orogustatory, emotional, tactile, or thermal experience (Gradin, Finnstrom, & Schollin, 2004). When breastfeeding is not possible, whether because of the unavailability of the mother or difficulties with breastfeeding, consider the use of expressed human milk by dropper, syringe, or bottle, which has been shown to soothe newborns experiencing procedural pain (Mathew & Mathew, 2003; Upadhyay et al., 2004; Taddio et al., 2008; Shah, Aliwalas, & Shah, 2006). Administration of human milk can also be combined with sucking, by dipping a pacifier (dummy) in the milk, as described below for sucrose.
  2. Although some studies have demonstrated the efficacy of human milk alone (Upadhyay et al., 2004; Shah, Aliwalas, & Shah, 2007), human milk may not be equivalent to breastfeeding because of breastfeeding's multicomponent experience. Breastfeeding throughout the painful procedure is likely to be superior to human milk alone on the basis of synergism between the components of breastfeeding (Gradin, Finnstrom, & Schollin, 2004; Shah, Aliwalas, & Shah, 2007).

Skin-to-Skin Contact

  1. Coordinating a breastfeeding session with the timing of the procedure is best, but, if this is not possible, skin-to-skin contact can comfort infants undergoing a procedure such as a heel lance. Skin-to-skin contact also gives the mother a caretaking role during the procedure that is unobtrusive, and by diminishing infant stress, it can increase maternal confidence as to her value to the infant (Gray, Watt, & Blass, 2000).
  2. Parental contact and sucrose may act synergistically to reduce pain in neonates. Therefore if feasible, this combination can be employed (Schechter et al., 2007). Sucrose taste—first studied 20 years ago—is readily available for increasing the efficacy of other non-pharmacologic techniques (Gradin, Finnstrom, & Schollin, 2004). Sucrose administration is covered in more detail in the section below. Sucrose and pacifier can both be combined with the skin-to-skin component of parental contact.

Sucrose and Sucking (in Combination or Separately)

Sucrose taste has been shown to be effective analgesia for newborns and young infants for minor procedures, but not for more painful experiences like bladder catheterizations:

  1. Sucrose and pacifier. The combination of oral sucrose and pacifier or non-nutritive sucking is remarkably soothing (Blass & Watt, 1999). This technique offers pain reduction to infants undergoing a wide variety of painful procedures, including heel lance, umbilical or percutaneous venous or arterial catheter insertion, central venous line placement, subcutaneous or intramuscular injection, lumbar puncture, circumcision, and endotracheal suction (Anand, 2001; Stevens, Yamada, & Ohlsson, 2004; Stevens et al., 2005). Because pain reduction achieved when using both sucrose and non-nutritive sucking is similar to that with breastfeeding, using a pacifier (dummy) dipped in 24% sucrose (by weight) solution whenever breastfeeding is not possible is an effective option (Blass & Watt, 1999; Akman et al., 2002). Sucrose administration should begin 2 minutes prior to the procedure. If use of a pacifier is not an available or acceptable option, sucrose can also be combined with sucking by dipping a clean, gloved (or non-gloved parental) finger in the sucrose solution. If sucking a pacifier or finger is not an option, administer a sucrose solution orally before the procedure (Anand, 2001). When parents are present, they should be educated that sweet substances other than breast milk and pacifiers both are recommended in the newborn period only for procedural pain.
  2. Glucose versus sucrose. Glucose has also been shown to be an acceptable and effective alternative analgesic (Axelin et al., 2009; Idam-Siuriun et al., 2008). Taste difference is not a factor. Studies in rat (Blass & Shide, 1994) and human (Okan et al., 2007) newborns have not shown a preference for sucrose over glucose. The commercial availability of sucrose (table sugar) may have increased its use.
  3. Sucrose by syringe. If use of a pacifier is not possible, administer 0.5–2mL of a 24% sucrose solution orally via syringe 2 minutes before the painful procedure (Anand, 2001; Shann, 2007). Several 24% sucrose solutions are commercially available. Sucrose administered by oro- or nasogastric tube is not analgesic.
  4. Pacifier alone. While pacifiers alone may decrease crying associated with painful procedures, they do not have the same effect on physiological parameters such as heart rate or vagal tone (Taddio, 2001: Porges & Lipsitt, 1993). Moreover, sucking a pacifier has been found to reduce pain only when the suck rate exceeds 30 sucks/minute (Stevens, Yamada, & Ohlsson, 2004). A pacifier (or clean gloved or parental finger) should be used as the sole soothing intervention only if breastfeeding, human milk, sucrose (or glucose), and skin-to-skin contact are unavailable because non-nutritive sucking has consistently been found to be better than no intervention at all (Pinelli, Symington, & Ciliska, 2002).
  5. Sucrose better than human milk? At least one study indicates that sucrose is more effective than human milk, when both are administered orally via syringe, at reducing infants' cry time, recovery time (heart rate peak returns to baseline), and change in heart rate (Ors et al., 1999). The sugar in human milk is lactose, which has been shown to be an ineffective analgesic agent (Blass & Shide, 1994). The analgesic component of human milk may be attributed to its fat content or other constituents.

Soothing the Premature Newborn

Less research has been completed for this population, but there are several techniques that can be used to relieve pain in premature newborns. Breastfeeding may be problematic secondary to the medical status of the infant. Preterm infants may be medically compromised and/or may be developmentally unable to suck or swallow. In such cases, individual components of breastfeeding or a combination of the components of breastfeeding (e.g., contact and sweet taste) are available. Concerns about prolonged sucrose exposure in the premature infant are real. One study documented infants born at <31 weeks who were given a higher number of sucrose doses had lower scores in motor development and attention when assessed at term. There are no uniform gestational age criteria for studies on analgesia used in preterm infants. The following recommendations are based on studies of infants with an average gestational age of 30 weeks or greater. Not all studies have included infants between 28 and 30 weeks in gestational age, however, and it is unclear if the following recommendations are applicable to that age range. The data do not allow us to extrapolate these recommendations to the smallest premature infants (<27 weeks).

  1. Skin-to-skin contact provides effective pain reduction for premature newborns (Ludington-Hoe, Hosseini, & Torowicz, 2005; Johnston et al., 2003).
  2. In very-low-birth-weight neonates (27–31 weeks of gestation) undergoing consecutive heel lances, a pacifier dipped in sucrose or in water significantly reduced pain compared with infants who did not receive any intervention (Stevens et al., 1999).
  3. The value of sucrose as a pain reducer in the preterm infant is well established (Johnston et al., 2002; Ramenghi et al., 1996; Abad et al., 1996; Johnston et al., 1999). The recommended dosage in this population is 0.1–0.4mL of 24% sucrose solution. (Anand, 2001; Abad et al., 1996). Further pain reduction can be achieved when preterm infants receive 24% sucrose as three doses (0.1 mL, 2 minutes apart given 2 minutes and immediately prior to heel lance and 2 minutes after lance) rather than as a single dose (Johnston et al., 1999).
  4. The efficacy of breastfeeding and human milk as a pain reducer for the preterm or low-birth-weight infant is not well established in the current literature and should be the subject of further research; no studies have been performed specifically in this population. Regardless, if a mother wishes to breastfeed or provide her infant with human milk instead of sucrose, this should not be discouraged.
  5. Skin-to-skin contact plus sucrose has not been formally evaluated in premature infants, but may provide pain reduction for the preterm or low-birth-weight neonate.

Soothing the Older Infant (1 Month to 1 Year of Age)

Breastfeeding or its components as an analgesic technique has not been fully researched across this older population. For children older than a year, the focus of published literature is on the use of distraction techniques, which falls outside the scope of this protocol.

  1. Sucrose. Two recent meta-analyses of 10 and 14 randomized clinical trials (RCTs) on infant pain (Shah et al., 2009; Harrison et al., 2010) found sucrose to be an effective pain management strategy for infants and children up to 12 months of age. Two milliliters of 25% sucrose was effective during vaccination up to 6 months of age (Lewindon, Harkness, & Lewindon, 1998); however, 2mL of 24% sucrose was not effective for possibly more painful procedures like bladder catheterization in children older than 1 month of age (Rogers et al., 2006). Increasing the concentration of sucrose solution may be more effective as the infant ages (Harrison et al., 2010). One study explored the pain-relieving qualities of sucrose in children up to 48 months of age (Dilli, Kucuk, & Dallar, 2009) and found effectiveness compared to no treatment. Others, however, report lack of effectiveness with lower concentrations and younger ages (Lewindon, Harkness, & Lewindon, 1998; Barr et al., 1995). Sucrose taste alone was effective for one vaccination up to 12 months of age (Thyr et al., 2007) but did not demonstrate similar analgesia for multiple (three) vaccinations (Mowery, 2007). The higher concentrations of sucrose solutions may be more effective at older ages (Ramenghi et al., 2002); however, the majority of studies used differing concentrations, therefore precluding recommendations on the optimal concentration and dose (Shah et al., 2009; Harrison et al., 2010).
  2. Maternal/caretaker behavior. It has been noted that maternal behavior during a painful procedure accounts for up to 26% of infant pain behavior during both the procedure and the recovery period (Sweet & McGrath, 1998). Maternal distress was an especially important determinant of pain behavior in infants with low vagal tone compared to infants with high vagal tone (Sweet, McGrath, & Symons, 1999). Giving parents a caretaking role, such as securing or distracting the child, can reduce parental sense of helplessness. When parents are unavailable or unable to play a caretaking role, consider recruitment of another person (e.g., nurse) to help secure and/or distract the child (Schechter et al., 2007).
  3. If the infant is still breastfeeding, the mother should be invited to try it. Although the efficacy of breastfeeding and human milk as a pain reducer for older infants has not been extensively studied, there is potential benefit/minimal risk.
  4. The upper age limit of effectiveness of sucrose as a pain reducer has not been fully studied, and sucrose therefore cannot be recommended as a pain reducer in infants older than 12 months at this time (Schechter et al., 2007; Shah et al., 2009; Lewindon, Harkness, & Lewindon, 1998). A recent publication of workshop proceedings reviews the evidence for other techniques such as physical, psychological, and pharmacological interventions and has shown a range of non-pharmacologic treatments to be effective at reducing older childhood vaccine injection pain (Shah et al., 2009; Taddio et al., "Inadequate pain management," 2009; Taddio et al., "Physical interventions," 2009; Chambers et al., 2009).
Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

References Supporting the Recommendations
Type of Evidence Supporting the Recommendations

The type of evidence supporting the recommendations is not specifically stated.

The recommendations were based primarily on a comprehensive review of the existing literature. In cases where the literature does not appear conclusive, recommendations were based on the consensus opinion of the group of experts.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Reduction or elimination of procedure-related pain in the breastfeeding infant

Potential Harms

Not stated

Qualifying Statements

Qualifying Statements

A central goal of The Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient. These guidelines are not intended to be all-inclusive, but to provide a basic framework for physician education regarding breastfeeding.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
Academy of Breastfeeding Medicine Protocol Committee. ABM clinical protocol #23: Non-pharmacologic management of procedure-related pain in the breastfeeding infant. Breastfeed Med. 2010 Dec;5(6):315-9. [59 references] PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 Dec
Guideline Developer(s)
Academy of Breastfeeding Medicine - Professional Association
Source(s) of Funding

Academy of Breastfeeding Medicine

This work was supported in part by a grant from the Maternal and Child Health Bureau, U.S. Department of Health and Human Services.

Guideline Committee

Academy of Breastfeeding Medicine Protocol Committee

Composition of Group That Authored the Guideline

Academy of Breastfeeding Medicine Protocol Committee: Maya Bunik, M.D., MSPH, FABM; *Caroline J. Chantry, M.D., FABM; Cynthia R. Howard, M.D., MPH, FABM; Ruth A. Lawrence, M.D., FABM; Kathleen A. Marinelli, M.D., FABM, (Committee Chairperson); Larry Noble, M.D., FABM, (Translations Chairperson); Nancy G. Powers, M.D., FABM; Julie Scott Taylor, M.D., M.Sc., FABM

Contributors: *Larry Gray, M.D.; *Patel Tanvi, M.D.; *Elizabeth Garza, M.D.

*Primary contributors

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

Academy of Breastfeeding Medicine (ABM) protocols expire 5 years from the date of publication. Evidence-based revisions are made within 5 years or sooner if there are significant changes in the evidence.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the Academy of Breastfeeding Medicine Web site External Web Site Policy.

Print copies: Available from the Academy of Breastfeeding Medicine, 140 Huguenot Street, 3rd floor, New Rochelle, New York 10801

Availability of Companion Documents

The following is available:

Print copies: Available from the Academy of Breastfeeding Medicine, 140 Huguenot Street, 3rd floor, New Rochelle, New York 10801.

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on July 11, 2011.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Single copies may be downloaded for personal use. Copyright permission to be requested for use of multiple copies by e-mailing requests to abm@bfmed.org. An official request form will be sent electronically to person requesting multiple copy use.

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