OBJECTIVES: The objective was to compare the efficacy of an oral sucrose versus placebo in reducing pain in infants 1 to 3 months of age during intravenous (IV) cannulation in the emergency department. METHODS: A randomized, double-blind, placebo clinical trial was conducted. Participants were randomly allocated to receive 2 mL of an oral 88% sucrose solution or 2 mL of a placebo solution orally. The outcome measure were mean difference in pain score at 1 minute post-IV cannulation assessed by the Face, Legs, Activity, Cry, and Consolability Pain Scale (FLACC) and the Neonatal Infant Pain Scale (NIPS), crying time, and variations in heart rate. RESULTS: Eighty-seven participants completed the study, 45 in the sucrose group and 42 in the placebo group. There was no statistical difference in variations in both the FLACC score (p = 0.49) and the NIPS score (p = 0.36) between the two groups as per the Mann-Whitney U-test. With the same test, median crying times following IV cannulation were statistically significantly different between both groups (17 seconds in the sucrose group vs. 41 seconds in the placebo group, p = 0.04). Mean changes in heart rate 1 minute after IV cannulation were similar in both groups (16 +/- 4 beats/min for sucrose vs. 18 +/- 4 beats/min for placebo, p = 0.74). Side effects were similar for both groups and no adverse events were reported. CONCLUSIONS: Administration of an oral sucrose solution in infants 1 to 3 months of age during IV cannulation did not lead to statistically significant changes in pain scores. However, the cry time was significantly reduced.