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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by St. Justine's Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Serge Gouin, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01544985
First received: February 29, 2012
Last updated: March 5, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Pain
Drug: 88% sucrose po solution
Drug: placebo po
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Difference of pain scores using FLACC scale related to bladder catheterization [ Time Frame: 1 minute ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in pain scores using the NIPS scale related to bladder catheterization [ Time Frame: 1 minute ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: April 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Month to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544985

Contacts
Contact: Serge Gouin, MDCM, FRCPC 5143454931 ext 3498 sergegouin@aol.com

Locations
Canada, Quebec
CHU Ste-Justine Not yet recruiting
Montreal, Quebec, Canada, H3T1C5
Contact: Serge Gouin, MDCM, FRCPC    5143454931 ext 3498    sergegouin@aol.com   
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Serge Gouin, MDCM, FRCPC CHU Ste-Justine
  More Information

No publications provided

Responsible Party: Serge Gouin, Associate professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01544985     History of Changes
Other Study ID Numbers: Sucrose3456
Study First Received: February 29, 2012
Last Updated: March 5, 2012
Health Authority: Canada: Health Canada

Keywords provided by St. Justine's Hospital:
pediatrics
emergency medicine
pain
bladder catheterization

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014