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Trial of an Oral Sucrose Solution Versus Placebo in Children 1 to 3 Months Old Needing Bladder Catheterization

St. Justine's Hospital · 2012
ClinicalTrials.gov · Datasets · License: Public Domain · 2012
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emergency-medicinepainpediatrics
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
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