Pain | Effect on Pain of Oral Sucrose Versus Placebo in Children 1 to 3 Months Old Needing Venipuncture
Pain research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:88% sucrose po solution88% 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 poThe 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).
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
sucrose po88% 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.
placebo poThe 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).
Start Date: February 2011
Completed Date: June 2013
Phase: Phase 4
Primary Outcome: 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
Secondary Outcome: The difference in pain scores using the Neonatal Infant Pain Scale (NIPS).
Study sponsors, principal investigator, and references
Principal Investigator: Serge Gouin, MDCM, FRCPC
Lead Sponsor: St. Justine's Hospital
Collaborator: Canadian Association of Emergency Physicians