Non‐pharmacological management of infant and young child procedural pain Stable (no update expected for reasons given in 'What's new')

Abstract

Background

Infant acute pain and distress is commonplace. Infancy is a period of exponential development. Unrelieved pain and distress can have implications across the lifespan.  This is an update of a previously published review in the Cochrane Database of Systematic Reviews, Issue 10 2011 entitled 'Non‐pharmacological management of infant and young child procedural pain'.

Objectives

To assess the efficacy of non‐pharmacological interventions for infant and child (up to three years) acute pain, excluding kangaroo care, and music. Analyses were run separately for infant age (preterm, neonate, older) and pain response (pain reactivity, immediate pain regulation). 

Search methods

For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 2 of 12, 2015), MEDLINE‐Ovid platform (March 2015), EMBASE‐OVID platform (April 2011 to March 2015), PsycINFO‐OVID platform (April 2011 to February 2015), and CINAHL‐EBSCO platform (April 2011 to March 2015). We also searched reference lists and contacted researchers via electronic list‐serves. New studies were incorporated into the review. We refined search strategies with a Cochrane‐affiliated librarian. For this update, nine articles from the original 2011 review pertaining to Kangaroo Care were excluded, but 21 additional studies were added.

Selection criteria

Participants included infants from birth to three years. Only randomised controlled trials (RCTs) or RCT cross‐overs that had a no‐treatment control comparison were eligible for inclusion in the analyses. However, when the additive effects of a non‐pharmacological intervention could be assessed, these studies were also included. We examined studies that met all inclusion criteria except for study design (e.g. had an active control) to qualitatively contextualize results. There were 63 included articles in the current update.

Data collection and analysis

Study quality ratings and risk of bias were based on the Cochrane Risk of Bias Tool and GRADE approach. We analysed the standardized mean difference (SMD) using the generic inverse variance method.

Main results

Sixty‐three studies, with 4905 participants, were analysed. The most commonly studied acute procedures were heel‐sticks (32 studies) and needles (17 studies). The largest SMD for treatment improvement over control conditions on pain reactivity were: non‐nutritive sucking‐related interventions (neonate: SMD ‐1.20, 95% CI ‐2.01 to ‐0.38) and swaddling/facilitated tucking (preterm: SMD ‐0.89; 95% CI ‐1.37 to ‐0.40). For immediate pain regulation, the largest SMDs were: non‐nutritive sucking‐related interventions (preterm: SMD ‐0.43; 95% CI ‐0.63 to ‐0.23; neonate: SMD ‐0.90; 95% CI ‐1.54 to ‐0.25; older infant: SMD ‐1.34; 95% CI ‐2.14 to ‐0.54), swaddling/facilitated tucking (preterm: SMD ‐0.71; 95% CI ‐1.00 to ‐0.43), and rocking/holding (neonate: SMD ‐0.75; 95% CI ‐1.20 to ‐0.30). Fifty two of our 63 trials did not report adverse events. The presence of significant heterogeneity limited our confidence in the findings for certain analyses, as did the preponderance of very low quality evidence.

Authors' conclusions

There is evidence that different non‐pharmacological interventions can be used with preterms, neonates, and older infants to significantly manage pain behaviors associated with acutely painful procedures. The most established evidence was for non‐nutritive sucking, swaddling/facilitated tucking, and rocking/holding. All analyses reflected that more research is needed to bolster our confidence in the direction of the findings. There are significant gaps in the existing literature on non‐pharmacological management of acute pain in infancy.

Author(s)

Rebecca R Pillai Riddell, Nicole M Racine, Hannah G Gennis, Kara Turcotte, Lindsay S Uman, Rachel E Horton, Sara Ahola Kohut, Jessica Hillgrove Stuart, Bonnie Stevens, Diana M Lisi

Abstract

Plain language summary

Drug‐free management of young children's pain during medical procedures 

Background:  Infant pain has been historically under‐managed.

Review question:  This review assessed 24 different ways of reducing young children's pain during medical procedures without using drugs, such as using a pacifier, distracting the child, and rocking a child. We analysed studies separately for babies who were born preterm, full‐term newborns, and older infants from one month to three years. We also looked at if there was a difference on the impact of the interventions depending on whether the infant had just had the painful procedure (pain reactivity), as opposed to calming down from their peak distress (immediate pain regulation).

Study characteristics:  This updated review examined 63 randomised controlled trials of 4905 participants.

Key results and Quality of evidence:  While there was evidence for non‐nutritive sucking, swaddling and tucking, massage, environment modification, rocking, video distraction, structured non‐parent involvement at different ages, and pain types, none of the analyses were based on sufficient evidence to allow us to draw firm conclusions (i.e. high quality studies from at least two independent laboratories).

Author(s)

Rebecca R Pillai Riddell, Nicole M Racine, Hannah G Gennis, Kara Turcotte, Lindsay S Uman, Rachel E Horton, Sara Ahola Kohut, Jessica Hillgrove Stuart, Bonnie Stevens, Diana M Lisi

Reviewer's Conclusions

Authors' conclusions 

Implications for practice 

Preterm infants:  The available evidence suggests that for preterm infants, touch/massage is effective in reducing pain immediately after a painful procedure. Non‐nutritive sucking, environmental modification, and swaddling/facilitated tucking can be used to reduce both pain immediately after a procedure and pain 30 seconds after a procedure. Including sucking with sucrose for pain immediately after a needle is effective as is adding facilitated tucking with non‐nutritive sucking for both pain reactivity and immediate pain regulation. All of these findings are based on low to very low quality evidence, which indicates that better quality evidence is needed to further substantiate these results.

Neonates:  The available evidence suggests that for neonates, sucking‐related interventions can be used to reduce pain immediately after a painful procedure and 30 seconds after the painful procedure. There is evidence that swaddling and facilitated tucking reduce pain in neonates immediately after a painful procedure. There is evidence that rocking/holding is a useful strategy for helping an infant to regulate from pain, but was not found to be effective in reducing pain immediately after a painful procedure. Finally, familiar odor has also been shown to be promising to reduce pain during the regulatory phase post‐needle. All of these findings are based on low to very low quality evidence, which indicates that better quality evidence is needed to further substantiate these results.

Older infants:  The available evidence suggests that for older infants, non‐nutritive sucking, such as a pacifier, is effective to help an infant regulate after a painful procedure. There is also evidence that touch/massage‐related interventions and structured non‐parent involvement are effective in immediate pain regulation. There is evidence for video distraction used to reduce pain throughout the post‐immunization phase. Overall, these findings are also based on low to very low quality evidence, which indicates that better quality evidence is needed to further substantiate these results.

Implications for research 

Based on the results of this review, significant gaps in the existing literature on non‐pharmacological management of acute pain in infancy can be discerned. Among the highest priority gaps are the need for well‐designed trials that study:

  • Sucking‐related interventions, swaddling/tucking‐related interventions, rocking/holding, touch/massage, familiar odor, video distraction. These have all been shown to be potentially effective but confidence is limited due to poor quality and lack of replication.
  • Structured‐caregiver interventions (parent and non‐parent) that are informed by established attachment theory. Over the first year of life, it has been argued that the caregiver is the most important context for the infants (Pillai Riddell 2009). Currently, studies that have attempted to formally structure parent behavior have been limited and, thus, shown to be ineffective. It should be stressed that more work on better types of parent/non‐parent interventions, especially ones that capitalize on an infant’s primary developmental need for proximity to the parent (Bowlby 1982), is needed. Teaching caregivers to better meet an infant’s attachment needs during times of pain may lead to more efficacious parent interventions.

In addition, preliminary work from other studies (excluded from our overall quantitative analyses for methodological reasons) suggests that feeding an infant formula, and administering the least painful immunization first are promising non‐pharmacological interventions that may reduce infant pain in the acute setting, but more structured research methodologies need to be applied.

A new aspect of the review, which emerged at the update stage based on changing trends in methodology, is the concept of 'additive' studies. In our analysis, we looked at studies that could offer evidence of the additive effect of a non‐pharmacological treatment on existing treatments. It is important to remember that trials of this nature, only speak to the additive effect of a given intervention on top of another intervention. These trials offer nothing about the original intervention. For example, in a well‐designed trial comparing the additive effect of sucking on co‐bedding + sucrose. There was no additive effect of sucking on co‐bedding + sucrose. But, this does not mean co‐bedding + sucrose does not have merit. Sucrose has been shown to be efficacious in reducing pain‐related behaviour. Whether co‐bedding adds to sucrose as an intervention is undetermined. A major challenge of researchers is to execute 'additive' trials that build on treatments that have demonstrated efficacy, while meeting the ethical guidelines we must uphold. Given the challenge of defining equipoise with a no‐treatment control group (see Harrison 2013, Pillai Riddell 2013c), more work must be done.

Another important point for future trialists is the meaning of heterogeneity estimates. Observational research on a large longitudinal study that used latent class analysis techniques to analyse infant pain responses over time, substantiate the assertion that there are different subgroups of pain responders (Pillai Riddell 2013b) that render average pain estimates (i.e. the key outcome in most non‐pharmacological trials for acute pain) meaningless, particularly in the regulation phase. Using covariates such as temperament estimates or conducting responder analyses may be options to remedy this situation. Additionally, it is not expected that future studies could be done for all interventions at all age groups. For example, non‐nutritive sucking may not be an appropriate intervention for three‐year olds. More research is needed in areas where the intervention would be developmentally appropriate.

Finally, sample size in treatment groups in trials studying non‐pharmacological treatments for infants must increase and investigators should work on replicating trials so that there can be independent corroborating evidence for a particular intervention.

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