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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01544985
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : December 22, 2015
Information provided by (Responsible Party):
Serge Gouin, St. Justine's Hospital

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Pain Drug: 88% sucrose po solution Drug: placebo po Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose
U.S. FDA Resources

Arm Intervention/treatment
Experimental: sucrose po
88% sucrose solution (Syrup B.P.)
Drug: 88% sucrose po solution
88% sucrose solution (Syrup B.P.)
Placebo Comparator: placebo po
sterile water
Drug: placebo po
sterile water

Primary Outcome Measures :
  1. Difference of pain scores using FLACC scale related to bladder catheterization [ Time Frame: 1 minute ]

Secondary Outcome Measures :
  1. Difference in pain scores using the NIPS scale related to bladder catheterization [ Time Frame: 1 minute ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Infants from 1 to 3 months (one month or more but less than 3 months old) of actual age (not corrected) requiring bladder catheterization as a part of their planned ED management while a research assistant is present.

Exclusion Criteria:

  • Preterm infants (i.e. born <37 weeks)
  • Urogenital anomalies
  • Acute severe respiratory illness
  • Chronic cardio-pulmonary condition
  • Assisted ventilation (such as tracheostomy or oxygen dependance)
  • Technology dependant (such as enteral feeding tube)
  • Oropharyngeal malformation or dysfunction (such as cleft palate or micrognathia)
  • Metabolic disease
  • Previous participation in this study
  • Painful procedures in the preceding 60 minutes (bladder catheterization, vesical puncture, lumbar puncture, capillary blood tests or IV insertion)
  • Parental language barrier (French and/or English)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01544985

Canada, Quebec
CHU Ste-Justine
Montreal, Quebec, Canada, H3T1C5
Sponsors and Collaborators
St. Justine's Hospital
Principal Investigator: Serge Gouin, MDCM, FRCPC St. Justine's Hospital

Responsible Party: Serge Gouin, Associate professor, St. Justine's Hospital Identifier: NCT01544985     History of Changes
Other Study ID Numbers: Sucrose3456
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015

Keywords provided by Serge Gouin, St. Justine's Hospital:
emergency medicine
bladder catheterization

Additional relevant MeSH terms:
Pharmaceutical Solutions