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

NCT01293812 | Completed Phase 4

• 1 other identifier: Sucrose#3236
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

  one minute

Secondary Outcomes (1)

• The difference in pain scores using the Neonatal Infant Pain Scale (NIPS).

  one minute

Study Arms (2)

sucrose po

EXPERIMENTAL

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

placebo po

PLACEBO COMPARATOR

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

Interventions

88% sucrose po solution DRUG

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).

sucrose po

placebo po DRUG

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).

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

You may not qualify if:

• Preterm infants (i.e. born \< 37 weeks)
• Acute respiratory illness
• Chronic cardio-pulmonary condition
• Assisted ventilation (such as tracheostomy or oxygen dependance)
• Technology dependant (such as enteral feeding tube)
• Developmental delay
• 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)
• Parental language barrier (French and/or English)

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Canadian Association of Emergency Physicians: collaborator

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: Asociate Professor

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 11, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

CA (1)