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.

Pain in long-term survivors of childhood cancer: A systematic review of the current state of knowledge and a call to action from the Children's Oncology Group.

Survivors of childhood cancer may be at risk of experiencing pain, and a systematic review would advance our understanding of pain in this population. The objective of this study was to describe: 1) the prevalence of pain in survivors of childhood cancer, 2) methods of pain measurement, 3) associations between pain and biopsychosocial factors, and 4) recommendations for future research. Data sources for the study were articles published from January 1990 to August 2019 identified in the PubMed, PsycINFO, EMBASE, and Web of Science data bases. Eligible studies included: 1) original research, 2) quantitative assessments of pain, 3) articles published in English, 4) cancers diagnosed between birth and age 21 years, 5) survivors at 5 years from diagnosis and/or at 2 years after therapy completion, and 6) a sample size >20. Seventy-three articles were included in the final review. Risk of bias was considered using the Cochrane risk of bias tool. The quality of evidence was evaluated according to Grading of Recommendations Assessment Development and Evaluation (GRADE) criteria. Common measures of pain were items created by the authors for the purpose of the study (45.2%) or health-related quality-of-life/health status questionnaires (42.5%). Pain was present in from 4.3% to 75% of survivors across studies. Three studies investigated chronic pain according the definition in the International Classification of Diseases. The findings indicated that survivors of childhood cancer are at higher risk of experiencing pain compared with controls. Fatigue was consistently associated with pain, females reported more pain than males, and other factors related to pain will require stronger evidence. Theoretically grounded, multidimensional measurements of pain are absent from 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.

Differential Associations of Adverse Childhood Experience on Maternal Health.

INTRODUCTION: The current study examined whether three distinct antecedent factors related to maternal adverse childhood experiences were differentially associated with maternal health and psychosocial outcomes in the antepartum period. It was hypothesized that all three adverse childhood experience factors would be positively associated with poor health prior to pregnancy, poor reproductive health history, and health complications and psychosocial difficulties during pregnancy. METHODS: Data from 1,994 women (mean age=30.87 years) and their infants were collected from a prospective longitudinal cohort from 2008 to 2011. Pregnant women completed self-report questionnaires and a healthcare professional assessed the mothers' health prior to pregnancy, reproductive history, and pregnancy complications. RESULTS: Data analyses were conducted from December 2016 to March 2017. Path analysis demonstrated that women who had experience with physical/emotional abuse in childhood were significantly more likely to enter pregnancy with a chronic health condition (AOR=1.25, 95% CI=1.02, 1.54) and to have psychosocial difficulties in their pregnancy (AOR=1.60, 95% CI=1.34, 1.89). Women who were exposed to household dysfunction in childhood were also significantly more likely to experience psychosocial difficulties during pregnancy (AOR=2.33, 95% CI=1.49, 3.65). There was no association between exposure to sexual abuse and maternal health or mental health outcomes. CONCLUSIONS: Adverse childhood experience categories differentially predicted maternal health and psychosocial outcomes prior to and during pregnancy. The overall variance accounted for by adverse childhood experiences was small (3%-19%), suggesting that factors other than childhood adversity likely contribute to maternal health.

Patient-Reported Outcomes in Psychological Treatment for an Adolescent Oncology Patient: A Case Report.

This case study describes the use of patient-reported outcome (PRO) in conjunction with psychosocial treatment for an adolescent oncology patient presenting with comorbid mental health difficulties. A nine-session evidence-based cognitive-behavioral treatment was implemented and PROs were used to document progress. Results demonstrated an overall pattern of increase in health-related quality of life and decrease in mood and anxiety symptoms as treatment progressed, with increases occurring after disease recurrence. This case study demonstrates the importance and utility of PROs. Implications for psychosocial treatment of adolescent and young adult patients and directions for future research are discussed.

Predicting preschool pain-related anticipatory distress: the relative contribution of longitudinal and concurrent factors.

Anticipatory distress prior to a painful medical procedure can lead to negative sequelae including heightened pain experiences, avoidance of future medical procedures, and potential noncompliance with preventative health care, such as vaccinations. Few studies have examined the longitudinal and concurrent predictors of pain-related anticipatory distress. This article consists of 2 companion studies to examine both the longitudinal factors from infancy as well as concurrent factors from preschool that predict pain-related anticipatory distress at the preschool age. Study 1 examined how well preschool pain-related anticipatory distress was predicted by infant pain response at 2, 4, 6, and 12 months of age. In study 2, using a developmental psychopathology framework, longitudinal analyses examined the predisposing, precipitating, perpetuating, and present factors that led to the development of anticipatory distress during routine preschool vaccinations. A sample of 202 caregiver-child dyads was observed during their infant and preschool vaccinations (the Opportunities to Understand Childhood Hurt cohort) and was used for both studies. In study 1, pain response during infancy was not found to significantly predict pain-related anticipatory distress at preschool. In study 2, a strong explanatory model was created whereby 40% of the variance in preschool anticipatory distress was explained. Parental behaviours from infancy and preschool were the strongest predictors of child anticipatory distress at preschool. Child age positively predicted child anticipatory distress. This strongly suggests that the involvement of parents in pain management interventions during immunization is one of the most critical factors in predicting anticipatory distress to the preschool vaccination.

Systematic Review: Predisposing, Precipitating, Perpetuating, and Present Factors Predicting Anticipatory Distress to Painful Medical Procedures in Children.

OBJECTIVE: To conduct a systematic review of the factors predicting anticipatory distress to painful medical procedures in children. METHODS: A systematic search was conducted to identify studies with factors related to anticipatory distress to painful medical procedures in children aged 0-18 years. The search retrieved 7,088 articles to review against inclusion criteria. A total of 77 studies were included in the review. RESULTS: 31 factors were found to predict anticipatory distress to painful medical procedures in children. A narrative synthesis of the evidence was conducted, and a summary figure is presented. CONCLUSIONS: Many factors were elucidated that contribute to the occurrence of anticipatory distress to painful medical procedures. The factors that appear to increase anticipatory distress are child psychopathology, difficult child temperament, parent distress promoting behaviors, parent situational distress, previous pain events, parent anticipation of distress, and parent anxious predisposition. Longitudinal and experimental research is needed to further elucidate these factors.

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.

Caregiver Emotional Availability, Caregiver Soothing Behaviors, and Infant Pain During Immunization.

OBJECTIVE: To determine whether caregivers with more extreme emotional availability scores enact different levels of soothing behaviors and whether infants of these caregivers differ in their pain scores across the first year of life. METHODS: Cross-sectional analyses (analyses of variance and multivariate analyses of variance) were conducted with parent-infant dyads at 2, 4, 6, and 12 months of age who had extreme caregiver emotional availability scores. Pain scores were examined using a minimum clinically significant difference. RESULTS: Infants with lower pain scores had caregivers who were in the high emotional availability group. This effect was most pronounced during the regulatory period at 2 months, and clinically significant differences in pain scores were found during the regulatory period at 12 months. Physical comforting and/or rocking were characteristic of caregivers with high emotional availability. CONCLUSION: This study suggests that caregiver emotional availability, in the extremes, do have clinically meaningful relationships with infant pain regulation.

A longitudinal examination of verbal reassurance during infant immunization: occurrence and examination of emotional availability as a potential moderator*.

OBJECTIVE: This study investigated the associations between caregiver verbal reassurance and infant pain-related distress during immunization over the first year of life. The relationships between verbal reassurance and caregiver emotional availability (EA) were also examined. Finally, EA was investigated as a moderator of the relationship between verbal reassurance and infant pain. METHODS: A cross-sectional analysis was conducted with 606 infants (and their parents) at 4 different ages (n = 376 at 2 months, n = 455 at 4 months, n = 484 at 6 months, and n = 407 at 12 months). RESULTS: Verbal reassurance was positively associated with infant distress across all four ages. EA was only negatively related to verbal reassurance at 12 months of age. EA was not a significant moderator at any age. CONCLUSION: Findings demonstrate consistent but small relationships between verbal reassurance and infant pain over the first year of life.

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.  OBJECTIVES: To assess the efficacy of non-pharmacological interventions for infant and child (up to three years) acute pain, excluding breastmilk, sucrose, and music. Analyses accounted for infant age (preterm, neonate, older) and pain response (pain reactivity, pain-related regulation).  SEARCH STRATEGY: We searched CENTRAL in The Cochrane Library (2011, Issue 1), MEDLINE (1966 to April 2011), EMBASE (1980 to April 2011), PsycINFO (1967 to April 2011), Cumulative Index to Nursing and Allied Health Literature (1982 to 2011), Dissertation Abstracts International (1980 to 2011) and www.clinicaltrials.gov. We also searched reference lists and contacted researchers via electronic list-serves. SELECTION CRITERIA: Participants included infants from birth to three years. Only randomized controlled trials (RCTs) or RCT cross-overs that had a no-treatment control comparison were eligible for inclusion in the analyses. We examined studies that met all inclusion criteria except for study design (e.g. had an active control) to qualitatively contextualize results. DATA COLLECTION AND ANALYSIS: We refined search strategies with three Cochrane-affiliated librarians. At least two review authors extracted and rated 51 articles. Study quality ratings were based on a scale by Yates and colleagues. We analyzed the standardized mean difference (SMD) using the generic inverse variance method. We also provided qualitative descriptions of 20 relevant but excluded studies. MAIN RESULTS: Fifty-one studies, with 3396 participants, were analyzed. The most commonly studied acute procedures were heel-sticks (29 studies) and needles (n = 10 studies). The largest SMD for treatment improvement over control conditions on pain reactivity were: non-nutritive sucking-related interventions (preterm: SMD -0.42; 95% CI -0.68 to -0.15; neonate: SMD -1.45, 95% CI -2.34 to -0.57), kangaroo care (preterm: SMD -1.12, 95% CI -2.04 to -0.21), and swaddling/facilitated tucking (preterm: SMD -0.97; 95% CI -1.63 to -0.31). For immediate pain-related regulation, the largest SMDs were: non-nutritive sucking-related interventions (preterm: SMD -0.38; 95% CI -0.59 to -0.17; neonate: SMD -0.90, 95% CI -1.54 to -0.25), kangaroo care (SMD -0.77, 95% CI -1.50 to -0.03), swaddling/facilitated tucking (preterm: SMD -0.75; 95% CI -1.14 to -0.36), and rocking/holding (neonate: SMD -0.75; 95% CI -1.20 to -0.30). The presence of significant heterogeneity limited our confidence in the lack of findings for certain analyses. 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.