title: A randomized controlled trial of clinician-led tactile stimulation to reduce pain during vaccination in infants.
abstract: BACKGROUND
  Clinician-led tactile stimulation (rubbing the skin adjacent to the injection site or applying pressure) has been demonstrated to reduce pain in children and adults undergoing vaccination.
  
  
  OBJECTIVE
  To evaluate the analgesic effectiveness of clinician-led tactile stimulation in infants undergoing vaccination.
  
  
  METHODS
  This was a partially blinded randomized controlled trial that included infants undergoing vaccination in a private clinic in Toronto. Infants were randomly allocated to tactile stimulation or no tactile stimulation immediately prior to, during, and after vaccination. The primary outcome was infant pain, assessed using a validated observational measure, the Modified Behavioral Pain Scale (MBPS; range = 0-10).
  
  
  RESULTS
  Altogether, 121 infants participated (n = 62 tactile stimulation; n = 59 control); demographics did not differ (P > .05) between groups. MBPS scores did not differ between groups: mean = 7.2 (standard deviation = 2.4) versus 7.6 (1.9); P = .245.
  
  
  CONCLUSIONS
  Tactile stimulation cannot be recommended as a strategy to reduce vaccination pain in infants because of insufficient evidence of a benefit.
authors.affiliation: University of Toronto, ON, Canada The Hospital for Sick Children, Toronto, ON, Canada anna.taddio@utoronto.ca.
authors.forename: Anna
authors.initials: A
authors.lastname: Taddio
authors.affiliation: Dr Tommy Ho Paediatric Clinic, Toronto, ON, Canada.
authors.forename: Tommy
authors.initials: T
authors.lastname: Ho
authors.affiliation: University of Toronto, ON, Canada.
authors.forename: Charmy
authors.initials: C
authors.lastname: Vyas
authors.affiliation: University of Toronto, ON, Canada.
authors.forename: Suganthan
authors.initials: S
authors.lastname: Thivakaran
authors.affiliation: University of Toronto, ON, Canada.
authors.forename: Ali
authors.initials: A
authors.lastname: Jamal
authors.affiliation: University of Toronto, ON, Canada.
authors.forename: Andrew F
authors.initials: AF
authors.lastname: Ilersich
authors.affiliation: University of Toronto, ON, Canada.
authors.forename: Mary-Ellen
authors.initials: ME
authors.lastname: Hogan
authors.affiliation: Mount Sinai Hospital, Toronto, ON, Canada.
authors.forename: Vibhuti
authors.initials: V
authors.lastname: Shah
mesh_terms: D005260:Female; D006801:Humans; D007223:Infant; D007267:Injections / Q000009:adverse effects*; D008297:Male; D009864:Ontario; D010146:Pain / Q000517:prevention & control*; D010147:Pain Measurement; D014110:Touch; D014611:Vaccination / Q000009:adverse effects*
keywords: pain management; randomized controlled trial; tactile stimulation; vaccination