Be sweet to toddlers during needles: Pilot randomized controlled trial of sucrose compared to placebo

Abstract

Sweet solutions reduce procedural pain in infants but there is uncertainty about effectiveness beyond infancy. A blinded pilot randomized controlled trial (RCT) was conducted to inform a full-scale RCT. Hospitalized children aged 12-36 months were randomized to 24% sucrose or water prior to and during venipuncture. Primary outcomes were crying time and FLACC (Face, Legs, Activity, Cry, Consolability) scores. Secondary outcomes parental report of child’s pain, parental perception of effectiveness and nurse’s score of child’s compliance with study solution. Twenty-one children were studied. There were no differences in pain outcomes between groups. Median FLACC scores at time of needle insertion were high (8/10), and mean crying time during procedure was 61%. Most parents (n=17) would use the same treatment next time and most (n=17) toddlers were compliant with receiving the solutions. The pilot RCT informed the conduct of a future full scale RCT in terms of feasibility, acceptability, data collection, data analysis and sample size estimation.