Effect on Pain of Oral Sucrose Versus Placebo in Children 1 to 3 Months Old Needing Venipuncture
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
Background : Previous studies suggest that early recognition and treatment of pain among
children is important for their cognitive development and their future response to pain
throughout their life. Oral sweet solutions have been accepted as effective pain reducing
agents for procedures in the neonatal population. To date, there have been a limited number
of published clinical trials in an emergency setting studying this type of intervention among
infants and these 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 in the Emergency Department (ED).
Methods : A single-center, randomized, double-blind, placebo controlled clinical trial will
be conducted in an urban tertiary care pediatric university-affiliated hospital ED. The study
population is all infants from 1 to 3 months of age requiring venipuncture as part of their
planned ED management. Study participants will be randomly allocated to receive 2 ml of a 88%
sucrose solution or 2 ml of a placebo solution. The primary outcome measure is the difference
in pain levels during the venipuncture in the study population as assessed by the Face, Legs,
Activity, Cry and Consolability Pain Scale (FLACC). Secondary outcome measures will evaluate
differences of pain levels using the Neonatal Infant Pain Scale (NIPS). Crying time and
changes in heart rate during the procedure will be recorded. Side effects and adverse events
will also be noted. The investigators will also measure the number of successful
venipunctures at the first attempt. 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 clinically
significant difference, approximately 41 patients per group will be needed considering a
drop-off value of 25%. Patients' characteristics and outcomes will be compared using the
Pearson Chi-square test for categorical variables and the Student's T test for continuous
variables. A intention to treat analysis will be performed.