16: A Randomized Double-Blind Trial Comparing the Effect on Pain of an Oral Sucrose Solution Versus Placebo in Children One to Three Months Old Needing Venipuncture

Abstract

Background: Oral sweet solutions have been accepted as effective analgesics for procedures in the neonatal population. There have been a limited number of published clinical trials in older infants for the commonly performed painful procedures in any setting. Objectives: To compare the efficacy of an oral sucrose solution versus placebo in reducing pain in children 1 to 3 months of age during venipuncture in the emergency department (ED). Methods: A single-center, randomized, double-blind, placebocontrolled clinical trial was conducted in an urban tertiary care pediatric university-affiliated hospital ED. All infants 1 to 3 months of age requiring venipuncture were randomly allocated to receive 2 ml of 88% sucrose solution or 2 ml of a placebo solution orally, 2 min before the procedure. The primary outcome measure was the difference in pain levels during venipuncture as assessed by the Face, Legs, Activity, Cry and Consolability Pain Scale (FLACC) 1 min post venipuncture. Secondary outcome measures were the difference in pain levels using the Neonatal Infant Pain Scale (NIPS), crying time, and variations in heart rate following the procedure. Results: Eighty-seven participants were recruited: 45 sucrose group, 42 placebo group. Overall, the groups had similar baseline demographic and clinical characteristics, including administration of pacifier and other analgesia. The mean difference in FLACC pain scores compared to baseline was 2.07 +/- 0.77 in the placebo group vs. 1.36 +/- 0.59 in the sucrose group (p=0.49). For the NIPS pain score, it was 1.73 +/- 0.62 in the placebo group vs. 0.75 +/- 0.58 in the sucrose group (p=0.36). The difference in the mean crying time following venipuncture was statistically significant between both groups (69 +/- 13 seconds in the placebo group vs. 49 +/- 13 in the sucrose group, p=0.04). No significant difference was found in the difference of participants' heart rates 1 min post venipuncture compared to baseline (18 +/- 4 beats/min. for placebo vs. 16 +/- 4 for sucrose, p=0.74). No significant adverse effects were reported. The overall blinding was successful. Conclusion: In children 1 to 3 months of age undergoing venipuncture in the ED, administration of an oral sweet solution did not statistically decrease pain scores as measured by the FLACC and NIPS scales or participants' heart rates. However, crying time was significantly decreased by providing sucrose instead of a placebo.