Trial of an Oral Sucrose Solution Versus Placebo in Children 1 to 3 Months Old Needing Bladder Catheterization
Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
INTRODUCTION AND JUSTIFICATION
The use of sucrose has been well studied for certain procedures in neonatal intensive care
unit patients and in the newborn nursery settings, particularly for venous blood draws,
capillary blood tests and circumcision. In these studies, infants receiving oral sucrose
solutions before procedures cried less and had overall decreased behavioural pain responses
when compared with those receiving placebo.
In Emergency Departments (ED), children undergo many painful procedures, such as bladder
catheterization, capillary blood tests, venipuncture and lumbar puncture. Only two studies
have examined the effectiveness of sweet solutions as an analgesic in the ED. A randomized
controlled trial in an emergency setting of sucrose and/or pacifier for infants receiving
venipuncture conducted by Curtis and al among infants of 0 to 6 months demonstrated a trend
in reducing pain among the sub-group of infants of 0 to 3 months. However, this study showed
no difference in pain scales after 3 months of age. Also, in a study examining the effect of
sucrose during bladder catheterization, the subgroup of infants 1 to 30 days old who received
a sweet solution showed smaller changes in pain scores, were less likely to cry during
catheterization and returned to baseline more quickly, in comparison with the placebo group.
However, among children of 31 to 90 days, there was no statistically significant difference
in pain scores. In this study, they used a sucrose solution of only 24% and as they said in
the discussion, it is possible that older infants, who on average received a smaller dose (in
milligrams per kilogram), were in fact underdosed.
Finally, the painful procedure chosen for this study is bladder catheterization. Bladder
catheterizations are frequently performed in the ED in this age group.
HYPOTHESIS The investigators believe that providing an oral sucrose solution during bladder
catheterization will decrease pain levels in infants 1 to 3 months of age.
OBJECTIVES The investigators primary objective is to compare the efficacy an oral 88% sucrose
solution to a placebo solution in reducing pain as assessed by the FLACC scale in children of
1 to 3 months during bladder catheterization in the ED. The investigators secondary objective
is to asses changes in pain levels as per the NIPS score. The investigators will also measure
variations in heart rate and crying time. All side effects will also be reported.