NCT01544985

A Randomized Double-blind Trial Comparing the Effect on Pain of an Oral Sucrose Solution Versus Placebo in Children 1 to 3 Months Old Needing Bladder Catheterization

Completed Phase 4 Last updated 21 December 2015

What this trial tests

Phase 4 trial testing 88% sucrose po solution in Pain in 84 participants. Completed in 1 April 2015.

Timeline

1 April 2012

Primary endpoint
1 April 2015

1 April 2015

Quick facts

Lead sponsor	St. Justine's Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	84
Start date	1 April 2012
Primary completion	1 April 2015
Estimated completion	1 April 2015
Sites	1 location across Canada

Drugs / interventions tested

• 88% sucrose po solution — full drug profile →
• placebo po — full drug profile →

Conditions studied

• Pain — all drugs for Pain →

Sponsor

St. Justine's Hospital

Who can join

Adults 1 Month to 3 Months, any sex, with Pain. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Difference of pain scores using FLACC scale related to bladder catheterization
  Time frame: 1 minute

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.