title: Non-pharmacological management of infant and young child procedural pain.
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'.
  
  
  OBJECTIVE
  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).
  
  
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  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.
  
  
  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.
authors.affiliation: Department of Psychology, York University, 4700 Keele Street, OUCH Laboratory, 2004/6 Sherman Health Sciences Building, Toronto, ON, Canada, M3J 1P3.
authors.forename: Rebecca R
authors.initials: RR
authors.lastname: Pillai Riddell
authors.forename: Nicole M
authors.initials: NM
authors.lastname: Racine
authors.forename: Hannah G
authors.initials: HG
authors.lastname: Gennis
authors.forename: Kara
authors.initials: K
authors.lastname: Turcotte
authors.forename: Lindsay S
authors.initials: LS
authors.lastname: Uman
authors.forename: Rachel E
authors.initials: RE
authors.lastname: Horton
authors.forename: Sara
authors.initials: S
authors.lastname: Ahola Kohut
authors.forename: Jessica
authors.initials: J
authors.lastname: Hillgrove Stuart
authors.forename: Bonnie
authors.initials: B
authors.lastname: Stevens
authors.forename: Diana M
authors.initials: DM
authors.lastname: Lisi
mesh_terms: D000208:Acute Disease; D059787:Acute Pain / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D002675:Child, Preschool; D006365:Heel; D006801:Humans; D007114:Immunization / Q000009:adverse effects; D007223:Infant; D007224:Infant Care / Q000379:methods*; D007231:Infant, Newborn; D007234:Infant, Premature; D009339:Needles / Q000009:adverse effects*; D059408:Pain Management; D018962:Phlebotomy / Q000009:adverse effects; D011677:Punctures / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D013391:Sucking Behavior