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

NCT01544985 | Completed Phase 4

• 1 other identifier: Sucrose3456
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Keywords

pediatrics; emergency medicine; pain; bladder catheterization

Outcome Measures

Primary Outcomes (1)

• Difference of pain scores using FLACC scale related to bladder catheterization

  1 minute

Secondary Outcomes (1)

• Difference in pain scores using the NIPS scale related to bladder catheterization

  1 minute

Study Arms (2)

sucrose po

EXPERIMENTAL

88% sucrose solution (Syrup B.P.)

Drug: 88% sucrose po solution

placebo po

PLACEBO COMPARATOR

sterile water

Drug: placebo po

Interventions

88% sucrose po solution DRUG

88% sucrose solution (Syrup B.P.)

sucrose po

placebo po DRUG

sterile water

placebo po

Eligibility Criteria

• Age: 1 Month - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Ste-Justine

Montreal, Quebec, H3T1C5, Canada

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Serge Gouin, MDCM, FRCPC

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 6, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

CA (1)