Non-pharmacological management of infant and young child procedural pain.

BACKGROUND: Despite evidence of the long-term implications of unrelieved pain during infancy, it is evident that infant pain is still under-managed and unmanaged. Inadequately managed pain in infancy, a period of exponential development, can have implications across the lifespan. Therefore, a comprehensive and systematic review of pain management strategies is integral to appropriate infant pain management. This is an update of a previously published review update in the Cochrane Database of Systematic Reviews (2015, Issue 12) of the same title. OBJECTIVES: To assess the efficacy and adverse events of non-pharmacological interventions for infant and child (aged up to three years) acute pain, excluding kangaroo care, sucrose, breastfeeding/breast milk, and music. SEARCH METHODS: For this update, we searched CENTRAL, MEDLINE-Ovid platform, EMBASE-OVID platform, PsycINFO-OVID platform, CINAHL-EBSCO platform and trial registration websites (ClinicalTrials.gov; International Clinical Trials Registry Platform) (March 2015 to October 2020). An update search was completed in July 2022, but studies identified at this point were added to 'Awaiting classification' for a future update.  We also searched reference lists and contacted researchers via electronic list-serves.  We incorporated 76 new studies into the review.  SELECTION CRITERIA: Participants included infants from birth to three years in randomised controlled trials (RCTs) or cross-over RCTs that had a no-treatment control comparison. Studies were eligible for inclusion in the analysis if they compared a non-pharmacological pain management strategy to a no-treatment control group (15 different strategies). In addition, we also analysed studies when the unique effect of adding a non-pharmacological pain management strategy onto another pain management strategy could be assessed (i.e. additive effects on a sweet solution, non-nutritive sucking, or swaddling) (three strategies). The eligible control groups for these additive studies were sweet solution only, non-nutritive sucking only, or swaddling only, respectively. Finally, we qualitatively described six interventions that met the eligibility criteria for inclusion in the review, but not in the analysis.  DATA COLLECTION AND ANALYSIS: The outcomes assessed in the review were pain response (reactivity and regulation) and adverse events. The level of certainty in the evidence and risk of bias were based on the Cochrane risk of bias tool and the GRADE approach. We analysed the standardised mean difference (SMD) using the generic inverse variance method to determine effect sizes.  MAIN RESULTS: We included total of 138 studies (11,058 participants), which includes an additional 76 new studies for this update. Of these 138 studies, we analysed 115 (9048 participants) and described 23 (2010 participants) qualitatively. We described qualitatively studies that could not be meta-analysed due to being the only studies in their category or statistical reporting issues. We report the results of the 138 included studies here. An SMD effect size of 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect. The thresholds for the I2 interpretation were established as follows: not important (0% to 40%); moderate heterogeneity (30% to 60%); substantial heterogeneity (50% to 90%); considerable heterogeneity (75% to 100%). The most commonly studied acute procedures were heel sticks (63 studies) and needlestick procedures for the purposes of vaccines/vitamins (35 studies). We judged most studies to have high risk of bias (103 out of 138), with the most common methodological concerns relating to blinding of personnel and outcome assessors. Pain responses were examined during two separate pain phases: pain reactivity (within the first 30 seconds after the acutely painful stimulus) and immediate pain regulation (after the first 30 seconds following the acutely painful stimulus). We report below the strategies with the strongest evidence base for each age group. In preterm born neonates, non-nutritive sucking may reduce pain reactivity (SMD -0.57, 95% confidence interval (CI) -1.03 to -0.11, moderate effect; I2 = 93%, considerable heterogeneity) and improve immediate pain regulation (SMD -0.61, 95% CI -0.95 to -0.27, moderate effect; I2 = 81%, considerable heterogeneity), based on very low-certainty evidence. Facilitated tucking may also reduce pain reactivity (SMD -1.01, 95% CI -1.44 to -0.58, large effect; I2 = 93%, considerable heterogeneity) and improve immediate pain regulation (SMD -0.59, 95% CI -0.92 to -0.26, moderate effect; I2 = 87%, considerable heterogeneity); however, this is also based on very low-certainty evidence. While swaddling likely does not reduce pain reactivity in preterm neonates (SMD -0.60, 95% CI -1.23 to 0.04, no effect; I2 = 91%, considerable heterogeneity), it has been shown to possibly improve immediate pain regulation (SMD -1.21, 95% CI -2.05 to -0.38, large effect; I2 = 89%, considerable heterogeneity), based on very low-certainty evidence. In full-term born neonates, non-nutritive sucking may reduce pain reactivity (SMD -1.13, 95% CI -1.57 to -0.68, large effect; I2 = 82%, considerable heterogeneity) and improve immediate pain regulation (SMD -1.49, 95% CI -2.20 to -0.78, large effect; I2 = 92%, considerable heterogeneity), based on very low-certainty evidence.  In full-term born older infants, structured parent involvement was the intervention most studied. Results showed that this intervention has little to no effect in reducing pain reactivity (SMD -0.18, 95% CI -0.40 to 0.03, no effect; I2 = 46%, moderate heterogeneity) or improving immediate pain regulation (SMD -0.09, 95% CI -0.40 to 0.21, no effect; I2 = 74%, substantial heterogeneity), based on low- to moderate-certainty evidence. Of these five interventions most studied, only two studies observed adverse events, specifically vomiting (one preterm neonate) and desaturation (one full-term neonate hospitalised in the NICU) following the non-nutritive sucking intervention. The presence of considerable heterogeneity limited our confidence in the findings for certain analyses, as did the preponderance of evidence of very low to low certainty based on GRADE judgements. AUTHORS' CONCLUSIONS: Overall, non-nutritive sucking, facilitated tucking, and swaddling may reduce pain behaviours in preterm born neonates. Non-nutritive sucking may also reduce pain behaviours in full-term neonates. No interventions based on a substantial body of evidence showed promise in reducing pain behaviours in older infants. Most analyses were based on very low- or low-certainty grades of evidence and none were based on high-certainty evidence. Therefore, the lack of confidence in the evidence would require further research before we could draw a definitive conclusion.

Understanding the concurrent and predictive relations between child-led emotion regulation behaviors and pain during vaccination in toddlerhood.

ABSTRACT: The purpose of this study was to further our understanding of early childhood pain-related distress regulation. Concurrent and predictive relations between child-led emotion regulation (ER) behaviors and pain-related distress during vaccination were examined at 2 different ages using autoregressive cross-lagged path analyses. Toddlers were video-recorded at the 12- and 18-month routine vaccination appointments (12-month-old [N = 163]; 18-month-old [N = 149]). At 1, 2, and 3 minutes postneedle, videos were coded for 3 clusters of child-led ER behaviors (disengagement of attention, parent-focused behaviors, and physical self-soothing) and pain-related distress. The concurrent and predictive relations between child-led ER behaviors and pain-related distress behaviors were assessed using 6 models (3 emotion regulation behaviors by 2 ages). At 18 months, disengagement of attention was significantly negatively related to pain-related distress at 1 minute postneedle, and pain-related distress at 1 minute postneedle was significantly related to less disengagement of attention at 2 minutes postneedle. Parent-focused behaviors had significant positive relations with pain-related distress at both ages, with stronger magnitudes at 18 months. Physical self-soothing was significantly related to less pain-related distress at both ages. Taken together, these findings suggest that disengagement of attention and physical self-soothing may serve more of a regulatory function during toddlerhood, whereas parent-focused behaviors may serve more of a function of gaining parent support for regulation. This study is the first to assess these relations during routine vaccination in toddlerhood and suggests that toddlers in the second year of life are beginning to play a bigger role in their own regulation from painful procedures than earlier in infancy.

Child Distress Expression and Regulation Behaviors: A Systematic Review and Meta-Analysis.

The goal of the current study was to review and meta-analyze the literature on relationships between child distress expression behaviors (e.g., cry) and three clusters of child distress regulation behaviors (disengagement of attention, parent-focused behaviors, and self-soothing) in the first three years of life. This review was registered with PROSPERO (CRD42020157505). Unique abstracts were identified through Medline, Embase, and PsycINFO (n = 13,239), and 295 studies were selected for full-text review. Studies were included if they provided data from infants or toddlers in a distress task, had distinct behavioral measures of distress expression and one of the three distress regulation clusters, and assessed the concurrent association between them. Thirty-one studies were included in the meta-analysis and rated on quality. Nine separate meta-analyses were conducted, stratified by child age (first, second, and third year) and regulation behavior clusters (disengagement of attention, parent-focused, and self-soothing). The weighted mean correlations for disengagement of attention behaviors were -0.28 (year 1), -0.44 (year 2), and -0.30 (year 3). For parent-focused behaviors, the weighted mean effects were 0.00 (year 1), 0.20 (year 2), and 0.11 (year 3). Finally, the weighted mean effects for self-soothing behaviors were -0.23 (year 1), 0.25 (year 2), and -0.10 (year 3). The second year of life showed the strongest relationships, although heterogeneity of effects was substantial across the analyses. Limitations include only analyzing concurrent relationships and lack of naturalistic distress paradigms in the literature.

Distress Responses in a Routine Vaccination Context: Relationships to Early Childhood Mental Health.

Social and emotional competencies, such as distress regulation, are established in early childhood and are critical for the development of children's mental health and wellbeing. Routine vaccinations in primary care provide a unique opportunity to relate responses to a universal, relatively standardized, distress regulation paradigm (i.e., pain-related distress) to key developmental outcomes. The current study sought to examine distress regulation during routine vaccination in infancy and preschool as predictors of outcomes related to socioemotional competence in preschool. It was hypothesized that children with poorer distress regulation abilities post-vaccination would have lower socioemotional development. Furthermore, it was hypothesized that insensitive parenting would exacerbate this relationship for children with poor distress regulation abilities. As part of an ongoing longitudinal cohort, 172 parent-child dyads were videotaped during vaccinations in infancy and preschool, and subsequently participated in a full-day psychological assessment in a university lab. Videotapes were coded for child pre-needle distress (baseline distress), immediate post-needle pain-related distress reactivity (immediate distress reactivity), and pain-related distress regulation (distress regulation). Parent sensitivity during the preschool vaccination was also coded. Baseline distress prior to vaccination predicted greater externalizing problems and behavioral symptoms. Parent sensitivity did not moderate the association between any child distress behaviors and socioemotional development indicators. Child distress behaviors prior to injection, regardless of parent behavior, during the vaccination context may provide valuable information to health care professionals about child socioemotional functioning in the behavioral and emotional domains.

Non-pharmacological management of infant and young child procedural pain.

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.