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

NCT01544985 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2015-12-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

88% sucrose po solution

88% sucrose solution (Syrup B.P.)

DRUG

placebo po

sterile water

Sponsors & Collaborators

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Serge Gouin, MDCM, FRCPC · St. Justine's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01544985 on ClinicalTrials.gov