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.

Non‐pharmacological management of infant and young child procedural pain

Background:
This systematic review assessed the effectiveness and safety of pharmacotherapy and combined interventions for reducing vaccine injection pain in individuals across the lifespan.

/pdf/pharmacological-and-combined-interventions-to-reduce-vaccine-4em0clwu8o.pdf

Pharmacological and Combined Interventions to Reduce Vaccine Injection Pain in Children and Adults: Systematic Review and Meta-Analysis.

Vaccine injections are the most frequent painful medical procedure performed worldwide. Numerous interventions have been evaluated to combat the pain from vaccine injections.1 These interventions can be broadly divided into pharmacological, psychological, procedural, and physical approaches. But for the costs of training clinicians, the majority of procedural and physical interventions offer the advantage of being time and resource cost neutral when compared with other approaches, and hence can be applied across clinical settings.

In a previous knowledge synthesis on this topic, we found support for several different procedural and physical interventions.2 These interventions were subsequently incorporated in a clinical practice guideline about childhood vaccination pain management.1 Since the original guideline was developed, additional research has been undertaken that has the potential to impact previous conclusions. In addition, the original guideline excluded research in adults, leaving a gap in best practices for this population. The current systematic review was therefore undertaken to update and expand the knowledge synthesis on this topic.3

This manuscript reports the results for the effects of the following procedural and physical interventions: (1) aspiration during intramuscular (IM) vaccine injection, (2) order of injection for sequential vaccine injections, (3) simultaneous versus sequential injection of multiple vaccines, (4) positioning of the individual undergoing vaccination, (5) anatomic location for the vaccine injection, (6) non-nutritive sucking during vaccination, (7) tactile stimulation (manual and vibration) during vaccination, (8) warming the vaccine, and (9) muscle tension (for individuals with a history of fainting). Breastfeeding, which combines physical (positioning and non-nutritive sucking) and pharmacological (sweet-tasting substances) elements, is included in a separate manuscript in this series.4 Similarly, we also separately report on the effects of combined interventions that include physical interventions (eg, non-nutritive sucking and sweet-tasting substances together) and the effectiveness of muscle tension in individuals with high levels of needle fear and a history of fainting.4,5

/pdf/procedural-and-physical-interventions-for-vaccine-injections-4hd93f2zpx.pdf

Procedural and Physical Interventions for Vaccine Injections: Systematic Review of Randomized Controlled Trials and Quasi-Randomized Controlled Trials

Educating parents about ways to minimize pain during routine infant vaccine injections at the point of care may positively impact on pain management practices. The objective of this cluster randomized trial was to determine the impact of educating parents about pain in outpatient pediatric clinics on their use of pain treatments during routine infant vaccinations. Four hospital-based pediatric clinics were randomized to intervention or control groups. Parents of 2- to 4-month-old infants attending the intervention clinics reviewed a pamphlet and a video about vaccination pain management on the day of vaccination, whereas those in the control clinics did not. Parent use of specific pain treatments (breastfeeding, sugar water, topical anesthetics, and/or holding of infants) on the education day and at subsequent routine vaccinations 2 months later was the primary outcome. Altogether, 160 parent-infant dyads (80 per group) participated between November 2012 and February 2014; follow-up data were available for 126 (79%). Demographics did not differ between groups (P > 0.05). On the education day and at follow-up vaccinations, use of pain interventions during vaccinations was higher in the intervention group (80% vs 26% and 68% vs 32%, respectively; P < 0.001 for both analyses). Educating parents about pain management in a hospital outpatient setting leads to higher use of pain interventions during routine infant vaccinations.

Impact of parent-directed education on parental use of pain treatments during routine infant vaccinations: a cluster randomized trial.

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. 

Non-pharmacological management of infant and young child procedural pain

BACKGROUND: To measure the analgesic effectiveness of the 5 S’s (swaddling, side/stomach position, shushing, swinging, and sucking) alone and combined with sucrose, during routine immunizations at 2 and 4 months. METHODS: We conducted a prospective, randomized, placebo-controlled trial with 2- and 4-month-old infants during well-child visits. Patients were assigned into 4 groups (2 × 2) receiving either 2 mL of water or 2 mL of 24% oral sucrose and then either standard-of-care comfort measures by parents or intervention with the 5 S’s immediately postvaccination. The Modified Riley Pain Score was used to score the infants’ pain at 15-second intervals for 2 minutes, then every 30 seconds up to 5 minutes postvaccination. Repeated-measures analysis of variance examined between group differences and within-subject variability of treatment effect on overall pain scores and length of crying. RESULTS: Two hundred thirty infants were enrolled. Results revealed significantly different mean pain scores between study groups with the exception of the 5S’s and 5S’s with sucrose groups. These 2 groups had lower similar mean scores over time, followed by sucrose alone, then control. The same trend was found with the proportion of children crying as with the mean pain score outcome measure. CONCLUSIONS: Physical intervention of the 5 S’s (swaddling, side/stomach position, shushing, swinging, and sucking) provided decreased pain scores on a validated pain scale and decreased crying time among 2- and 4-month-old infants during routine vaccinations. The use of 5S’s did not differ from 5S’s and sucrose.

/pdf/effective-analgesia-using-physical-interventions-for-infant-2g6uoib32t.pdf

Effective analgesia using physical interventions for infant immunizations.

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Effective analgesia using physical interventions for infant immunizations.