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

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

Interventions

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).

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).

Sponsors & Collaborators

• Canadian Association of Emergency Physicians

  collaborator INDUSTRY

• St. Justine's Hospital

  lead OTHER

Principal Investigators

• Serge Gouin, MDCM, FRCPC · St. Justine's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

3 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-02-28

Primary Completion

2013-02-28

Completion

2013-06-30

Countries

• Canada

Study Locations