Pain Due to Certain Specified Procedures Clinical Trial
Official title:
Be Sweet to Toddlers During Needles: RCT of Sucrose Compared to Placebo
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.
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.
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