Be Sweet to Toddlers: Does Sugar Water Reduce Pain During Blood Work?

Study Overview
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Brief Summary
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The purpose of this study is to determine whether sugar water (24% sucrose) effectively reduces pain in children ages 12 to 36 months undergoing venipuncture, as measured by pain scores and cry duration.

Detailed Description
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Background: Hospitalized children and children undergoing medical care as outpatients are frequently required to undergo needle-related procedures, such as venipuncture for diagnostic purposes and ongoing monitoring (Ellis, Sharp, Newhook, & Cohen, 2004). This procedure causes considerable pain and distress, especially in young children (Humphrey, Boon, van Linden van den Heuvell, & van de Wiel, 1992). Children rate needles as being the most distressing aspect of hospitalization (Kortesluoma & Nikkonen, 2006; Kortesluoma & Nikkonen, 2004), yet they are the most frequently performed skin-breaking procedure for hospitalized children (Cummings, Reid, Finley, McGrath, & Ritchie, 1996; Ellis, et al., 2004; Rennick, McHarg, Dell'Api, Johnston, & Stevens, 2008; Stevens et al., 2011). It is estimated that one-quarter of adults have developed a fear needles, most likely developed during childhood (Taddio et al., 2010; Wright, Yelland, Heathcote, Ng, & Wright, 2009). Being afraid of needles increases the risk of avoidance of needles for immunizations and medical care (Taddio et al., 2009; Wright, et al., 2009). It is therefore crucial that health care researchers and clinicians determine effective pain management strategies for young children, and consistently use such strategies in clinical care. Rationale: There is a paucity of evidence to support efficacy and feasibility of pain management strategies during needle-related painful procedures in young children, and uncertainties exist regarding analgesic effects of sweet solutions beyond infancy. Objectives: The primary objective of this study is to ascertain whether there is evidence of efficacy of oral 24% sucrose (TootSweet, Natural Product Number (NPN) 80021492; DandleLion Kisses, NPN 80075819) in toddlers (ages 12 to 36 months) compared to placebo (water) during venipuncture, as measured by pain scores and cry duration. Methods: A single-centre, phase IV, blinded, two-armed randomized controlled trial (RCT). Study population: Children aged 12 to 36 months, who are patients in the surgical/medical wards of an urban pediatric tertiary care centre who require venipuncture for the purpose of medically-required venous blood sampling. Sample size: Data from 140 toddlers; 70 randomized to receive sucrose and 70 randomized to receive water. Data collection: Enrolled children will be video-recorded during their procedure in order to permit completion of the primary outcome measurement at a later date by researchers blinded to the study solutions who were not part of the data collection process. Statistical analysis: The primary analysis will consist of a two-way ANOVA with main effects for intervention group and age group. As a secondary analysis, an interaction between intervention and age group will be tested. The primary analysis will be adapted to include adjustment for number of previous hospitalizations and length of current hospitalization and number of venipuncture attempts.

Official Title
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Be Sweet to Toddlers During Needles: RCT of Sucrose Compared to Placebo

Conditions
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Pain Due to Certain Specified Procedures

Intervention / Treatment
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* Drug: 24% sucrose
* Drug: Sterile water
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 12-36 months, inclusive Children who are patients at CHEO in the 4 East/West or 5 East wards (and overflow unit, when applicable), and the Medical Day Unit Children who require venipuncture for the purpose of medically required venous blood sampling With the exception of the age criteria, children who are eligible to receive sucrose as per the Sucrose CHEO policy for infants Children who have their venipuncture performed by hospital-employed phlebotomists or registered nurses (to ensure standardization of the blood collection procedure) Parents/guardians and children must also be able to understand English or French Exclusion Criteria: Children who have received a muscle relaxant, opioid analgesic or sedative in the past 24 hours (to ensure there is no interaction effect of these medications which may impact on toddlers' ability to mount a behavioral response to pain) Children who are ineligible to receive sucrose as per the Sucrose CHEO policy Children who are already consuming sweet fluids or foods, or if the mother wishes to breast feed during the procedure will also be excluded Children with known or suspected fructose intolerance

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 24% sucrose + standard care<br>In addition to standard care (topical anesthetic (Ametop or EMLA) + upright holding + distraction + pacifier, if used), a maximum of 2 ml 24% sucrose will be administered orally in 0.25 ml aliquots 2 minutes prior to the needle insertion, at the time of needle insertion, and repeated at 2 minute intervals until the completion of the procedure | Drug: 24% sucrose<br> <br> * Other names: DandleLion Kisses (NPN 80075819);Other: Standard care<br>* The current standard of care at the study site is use of topical anesthetic (Ametop or EMLA), upright holding of toddler by parent/caregiver during procedure, use of age appropriate nurse directed distraction, and sucking on a pacifier (if normally used by child)<br>|
| Placebo Comparator: Sterile water + standard care<br>In addition to standard care (topical anesthetic (Ametop or EMLA) + upright holding + distraction + pacifier, if used), a maximum of 2 ml sterile water will be administered orally in 0.25 ml aliquots 2 minutes prior to the needle insertion, at the time of needle insertion, and repeated at 2 minute intervals until the completion of the procedure | Drug: Sterile water<br> <br> Other: Standard care<br>* The current standard of care at the study site is use of topical anesthetic (Ametop or EMLA), upright holding of toddler by parent/caregiver during procedure, use of age appropriate nurse directed distraction, and sucking on a pacifier (if normally used by child)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cry duration | Cry is a valid measure of distress in young children and is an objective and easily measurable parameter. | Cry time will be measured from the time of needle insertion up to 30 seconds after the end of the venipuncture procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLACC (Face, Legs, Arms, Crying, Consolability) | The FLACC score is a validated 10-point scale composite pain score. | FLACC scores will be completed before and during the procedure and up to one minute after the end of the venipuncture procedure | 
| MBPS (Modified Behavioural Pain Scale) | The MBPS is a validated 10-point scale composite pain score. | MBPS scores will be completed before and during the procedure and up to one minute after the end of the venipuncture procedure | 
| Child's compliance with intervention | The child's compliance with the study solution during venipuncture will be recorded by the research personnel on the data collection sheet as a 3-point scale (Fully compliant, Somewhat compliant, Not compliant) and will be scored and documented following completion of the procedure. The research personnel will ask the parent or nurse in attendance, what they consider the child's compliance score was. | up to one minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sucrose, Pain