A RANDOMIZED DOUBLE-BLIND TRIAL ON THE EFFECT ON PAIN OF AN ORAL SUCROSE SOLUTION IN CHILDREN 1 TO 3 MONTHS OLD UNDERGOING SIMPLE VENIPUNCTURE
CPS ePoster Library. Gouin S. Jun 25, 2015; 99214; 152
Dr. Serge Gouin
Dr. Serge Gouin
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Abstract
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Background :
Previous studies suggest that early recognition and treatment of pain among children is very important for their cognitive development and their future response to pain throughout life. Oral sweet solutions have been accepted as effective analgesics for procedures in the neonatal population. While the evidence of effect has been established in neonates, there have been a limited number of published clinical trials in older infants for the commonly performed painful procedures in any setting and these few studies have shown conflicting results.

Objective :
To compare the efficacy of an oral sucrose solution versus placebo in reducing pain in children 1 to 3 months of age during venipuncture for blood tests in the Emergency Department (ED).


Design/methods :
A single-center, randomized, double-blind, placebo controlled clinical trial was conducted in an urban tertiary care pediatric university-affiliated hospital ED. The study population was all infants from 1 to 3 months of age requiring venipuncture for blood tests solely as part of their planned ED management. Study participants were randomly allocated to receive 2 ml of 88% sucrose solution or 2 ml of a placebo solution orally, two minutes 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) one minute post venipuncture. Secondary outcome measures were the difference in pain levels using the Neonatal Infant Pain Scale (NIPS) one minute post venipuncture, crying time and variations in heart rate following the procedure. Side effects and adverse events were also noted. Based on previously reported data, using an alpha value of 0.05, a power of 90% and using a 2-point difference in mean FLACC scores as a clinically significant difference, approximately 41 patients per group were needed considering a drop-off value of 25%.


Results :
Eighty-two participants were recruited, 41 in the sucrose group and 41 in the placebo group. Overall, both 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 3.67 ± .62 in the placebo group vs. 3.51 ± .64 in the sucrose group (p=.73). For the NIPS pain score, it was 3.00 ± .49 in the placebo group vs. 2.90 ± .47 in the sucrose group (p=.89). The difference in the mean crying time following venipuncture was not statistically significant between both groups (82 ± 5 seconds in the placebo group vs. 64 ± 3 in the sucrose group, p=.321). No significant difference was found in the difference of participants’ heart rates one minute post venipuncture compared to baseline (24 ± 5 beats per minute for placebo vs. 33 ± 6 for sucrose, p=.44). No significant adverse effects were reported. The overall blinding was successful.


Conclusions :
In children 1 to 3 months of age undergoing venous blood tests in the ED, administration of an oral sweet solution did not statistically decrease pain scores as measured by the FLACC and NIPS scales. The participants’ heart rate variations and crying time were not significantly changed by providing sucrose instead of a placebo.
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