title: Breast milk and glucose for pain relief in preterm infants: a noninferiority randomized controlled trial.
abstract: OBJECTIVE
  The study goal was to compare the efficacy of expressed breast milk (EBM) versus 25% glucose on pain responses of late preterm infants during heel lancing.
  
  
  METHODS
  In a noninferiority randomized controlled trial, a total of 113 newborns were randomized to receive EBM (experimental group [EG]) or 25% glucose (control group [CG]) before undergoing heel lancing. The primary outcome was pain intensity (Premature Infant Pain Profile [PIPP]) and a 10% noninferiority margin was established. Secondary outcomes were incidence of cry and percentage of time spent crying and adverse events. Intention-to-treat (ITT) analysis was used.
  
  
  RESULTS
  Groups were similar regarding demographics and clinical characteristics, except for birth weight and weight at data collection day. There were lower pain scores in the CG over 3 minutes after lancing (P < .001). A higher number of infants in the CG had PIPP scores indicative of minimal pain or absence of pain (P = .002 and P = .003 on ITT analysis) at 30 seconds after lancing, and the mean difference in PIPP scores was 3 (95% confidence interval: 1.507-4.483). Lower incidence of cry (P = .001) and shorter duration of crying (P = .014) were observed for CG. Adverse events were benign and self-limited, and there was no significant difference between groups (P = .736 and P = .637 on ITT analysis).
  
  
  CONCLUSIONS
  Results based on PIPP scores and crying time indicate poorer effects of EBM compared with 25% glucose during heel lancing. Additional studies exploring the vol and administration of EBM and its combination with other strategies such as skin-to-skin contact and sucking are necessary.
authors.affiliation: Department of Maternal-Child and Psychiatric Nursing, School of Nursing, University of São Paulo, São Paulo, Brazil. mariana.bueno@usp.br
authors.forename: Mariana
authors.initials: M
authors.lastname: Bueno
authors.forename: Bonnie
authors.initials: B
authors.lastname: Stevens
authors.forename: Patrícia Ponce
authors.initials: PP
authors.lastname: de Camargo
authors.forename: Edi
authors.initials: E
authors.lastname: Toma
authors.forename: Vera Lúcia Jornada
authors.initials: VL
authors.lastname: Krebs
authors.forename: Amélia Fumiko
authors.initials: AF
authors.lastname: Kimura
mesh_terms: D005260:Female; D005500:Follow-Up Studies; D005947:Glucose / Q000008:administration & dosage*; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008895:Milk, Human; D010146:Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D018962:Phlebotomy / Q000009:adverse effects; D011677:Punctures / Q000009:adverse effects; D012189:Retrospective Studies; D013549:Sweetening Agents / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D013549:Sweetening Agents; D005947:Glucose