Be Sweet to Toddlers During Needles: RCT of Sucrose Compared to Placebo
Overview
- Phase
- Phase 4
- Intervention
- 24% sucrose
- Conditions
- Pain Due to Certain Specified Procedures
- Sponsor
- Children's Hospital of Eastern Ontario
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Cry duration
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Denise Harrison
Chair in Nursing Care of Children, Youth and Families
Children's Hospital of Eastern Ontario
Eligibility Criteria
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
Arms & Interventions
24% sucrose + standard care
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
Intervention: 24% sucrose
24% sucrose + standard care
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
Intervention: Standard care
Sterile water + standard care
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
Intervention: Sterile water
Sterile water + standard care
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
Intervention: Standard care
Outcomes
Primary Outcomes
Cry duration
Time Frame: Cry time will be measured from the time of needle insertion up to 30 seconds after the end of the venipuncture procedure
Cry is a valid measure of distress in young children and is an objective and easily measurable parameter.
Secondary Outcomes
- FLACC (Face, Legs, Arms, Crying, Consolability)(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)(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(up to one minute)