Effect on Pain of Oral Sucrose Versus Placebo in Children 1 to 3 Months Old Needing Venipuncture

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  Recruiting
Sponsor:
Collaborator:
Canadian Association of Emergency Physicians
Information provided by (Responsible Party):
Serge Gouin, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01293812
First received: February 10, 2011
Last updated: February 29, 2012
Last verified: February 2012
  Purpose

Background : Previous studies suggest that early recognition and treatment of pain among children is important for their cognitive development and their future response to pain throughout their life. Oral sweet solutions have been accepted as effective pain reducing agents for procedures in the neonatal population. To date, there have been a limited number of published clinical trials in an emergency setting studying this type of intervention among infants and these studies have shown conflicting results.

Objective : To compare the efficacy of an oral sucrose solution versus placebo in reducing pain in children 1 to 3 months of age during venipuncture in the Emergency Department (ED).

Methods : A single-center, randomized, double-blind, placebo controlled clinical trial will be conducted in an urban tertiary care pediatric university-affiliated hospital ED. The study population is all infants from 1 to 3 months of age requiring venipuncture as part of their planned ED management. Study participants will be randomly allocated to receive 2 ml of a 88% sucrose solution or 2 ml of a placebo solution. The primary outcome measure is the difference in pain levels during the venipuncture in the study population as assessed by the Face, Legs, Activity, Cry and Consolability Pain Scale (FLACC). Secondary outcome measures will evaluate differences of pain levels using the Neonatal Infant Pain Scale (NIPS). Crying time and changes in heart rate during the procedure will be recorded. Side effects and adverse events will also be noted. The investigators will also measure the number of successful venipunctures at the first attempt. Based on previously reported data, using an alpha value of 0,05, a power of 90% and using a 2-point difference in mean FLACC scores as clinically significant difference, approximately 41 patients per group will be needed considering a drop-off value of 25%. Patients' characteristics and outcomes will be compared using the Pearson Chi-square test for categorical variables and the Student's T test for continuous variables. A intention to treat analysis will be performed.


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 Venipuncture

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Difference in pain scores related to venipuncture in the study population as assessed by the Face, Legs, Activity, Cry and Consolability Pain Scale before the administration of sucrose and one minute after the venipuncture [ Time Frame: one minute ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The difference in pain scores using the Neonatal Infant Pain Scale (NIPS). [ Time Frame: one minute ] [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: February 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sucrose po
88% sucrose solution (Syrup B.P.). The pharmacy will provide 2 syringes labeled "sucrose study" calculated to provide a 2 ml dose of a 88% sucrose solution.
Drug: 88% sucrose po solution
88% sucrose solution (Syrup B.P.) The pharmacy will provide 2 syringes labeled "sucrose study" calculated to provide a 2 ml dose of a 88% sucrose solution or a color, consistency- and odor-matched placebo in identical packagings (2 syringes per patient in the case the dose needs to be repeated).
Placebo Comparator: placebo po
The pharmacy will provide 2 syringes labeled "sucrose study" calculated to provide a 2 ml dose of a color, consistency- and odor-matched placebo to the sucrose solution in identical packagings (2 syringes per patient in the case the dose needs to be repeated).
Drug: placebo po
The pharmacy will provide 2 syringes labeled "sucrose study" calculated to provide a 2 ml dose of a solution or a color, consistency- and odor-matched placebo to the sucrose solution in identical packagings (2 syringes per patient in the case the dose needs to be repeated).

  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 a venipuncture as a part of their planned ED management during weekdays from 9h to 17h.

Exclusion Criteria:

  1. Preterm infants (i.e. born < 37 weeks)
  2. Acute respiratory illness
  3. Chronic cardio-pulmonary condition
  4. Assisted ventilation (such as tracheostomy or oxygen dependance)
  5. Technology dependant (such as enteral feeding tube)
  6. Developmental delay
  7. Oropharyngeal malformation or dysfunction (such as cleft palate or micrognathia)
  8. Metabolic disease
  9. Previous participation in this study
  10. Painful procedures in the preceding 60 minutes (bladder catheterization, vesical puncture, lumbar puncture, capillary blood tests)
  11. Parental language barrier (French and/or English)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293812

Locations
Canada, Quebec
CHU Ste-Justine Recruiting
Montreal, Quebec, Canada, H3T1C5
Contact: Serge Gouin, MD    5143454931 ext 3498    sergegouin@aol.com   
Contact: Alexia Messier, RN    5143454931 ext 3640      
Principal Investigator: Serge Gouin, MDCM, FRCPC         
Sponsors and Collaborators
St. Justine's Hospital
Canadian Association of Emergency Physicians
Investigators
Principal Investigator: Serge Gouin, MDCM, FRCPC CHU Ste-Justine
  More Information

No publications provided

Responsible Party: Serge Gouin, Asociate Professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01293812     History of Changes
Other Study ID Numbers: Sucrose#3236
Study First Received: February 10, 2011
Last Updated: February 29, 2012
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on April 16, 2014