Be Sweet to Toddlers: Does Sugar Water Reduce Pain During Blood Work?
Information source: Children's Hospital of Eastern Ontario
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain Due to Certain Specified Procedures
Intervention: TootSweet (24% sucrose) (Drug); Sterile water (Drug); Standard care (Other)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Children's Hospital of Eastern Ontario Official(s) and/or principal investigator(s): Denise Harrison, RN, PhD, Principal Investigator, Affiliation: Children's Hospital of Eastern Ontario
Overall contact: Denise Harrison, RN, PhD, Phone: 613-737-7600, Ext: 4140, Email: dharrison@cheo.on.ca
Summary
The purpose of this study is to determine whether sugar water (TootSweet, 24% sucrose)
effectively reduces pain in children ages 12 to 36 months undergoing venipuncture, as
measured by pain scores and cry duration
Clinical Details
Official title: Be Sweet to Toddlers During Needles: RCT of Sucrose Compared to Placebo
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Cry duration
Secondary outcome: FLACC (Face, Legs, Arms, Crying, Consolability)MBPS (Modified Behavioural Pain Scale) Child's compliance with intervention
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) 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 inpatients 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.
Eligibility
Minimum age: 12 Months.
Maximum age: 36 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Children aged 12-36 months, inclusive
- Children who are inpatients at CHEO in the 4 East/West or 5 East inpatient wards (and
overflow unit, when applicable)
- 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 registered nurses
of the CHEO Vascular Access Team (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
- Children with known or suspected sensitivity to Ametop or EMLA
Locations and Contacts
Denise Harrison, RN, PhD, Phone: 613-737-7600, Ext: 4140, Email: dharrison@cheo.on.ca
Children's Hospital of Eastern Ontario, Ottawa, Ontario K1H 8L1, Canada; Not yet recruiting Denise Harrison, RN, PhD, Principal Investigator Nick Barrowman, PhD, Sub-Investigator Brenda Martelli, RN(EC), MEd, Sub-Investigator Betty Rowley, RN, BScN, Sub-Investigator Sandra Dragic, RN, Sub-Investigator RĂ©gis Vaillancourt, Pharm.D, Sub-Investigator Helen Yoxon, RN, Sub-Investigator
Additional Information
Related publications: Ellis JA, Sharp D, Newhook K, Cohen J. Selling comfort: A survey of interventions for needle procedures in a pediatric hospital. Pain Manag Nurs. 2004 Dec;5(4):144-52. Humphrey GB, Boon CM, van Linden van den Heuvell GF, van de Wiel HB. The occurrence of high levels of acute behavioral distress in children and adolescents undergoing routine venipunctures. Pediatrics. 1992 Jul;90(1 Pt 1):87-91. Kortesluoma RL, Nikkonen M. 'The most disgusting ever': children's pain descriptions and views of the purpose of pain. J Child Health Care. 2006 Sep;10(3):213-27. Kortesluoma RL, Nikkonen M. 'I had this horrible pain': the sources and causes of pain experiences in 4- to 11-year-old hospitalized children. J Child Health Care. 2004 Sep;8(3):210-31. Cummings EA, Reid GJ, Finley GA, McGrath PJ, Ritchie JA. Prevalence and source of pain in pediatric inpatients. Pain. 1996 Nov;68(1):25-31. Stevens BJ, Abbott LK, Yamada J, Harrison D, Stinson J, Taddio A, Barwick M, Latimer M, Scott SD, Rashotte J, Campbell F, Finley GA; CIHR Team in Children's Pain. Epidemiology and management of painful procedures in children in Canadian hospitals. CMAJ. 2011 Apr 19;183(7):E403-10. doi: 10.1503/cmaj.101341. Epub 2011 Apr 4. Rennick JE, McHarg LF, Dell'Api M, Johnston CC, Stevens B. Developing the Children's Critical Illness Impact Scale: capturing stories from children, parents, and staff. Pediatr Crit Care Med. 2008 May;9(3):252-60. doi: 10.1097/PCC.0b013e31816c70d4. Taddio A, Appleton M, Bortolussi R, Chambers C, Dubey V, Halperin S, Hanrahan A, Ipp M, Lockett D, MacDonald N, Midmer D, Mousmanis P, Palda V, Pielak K, Riddell RP, Rieder M, Scott J, Shah V. Reducing the pain of childhood vaccination: an evidence-based clinical practice guideline. CMAJ. 2010 Dec 14;182(18):E843-55. doi: 10.1503/cmaj.101720. Epub 2010 Nov 22. Review. Wright S, Yelland M, Heathcote K, Ng SK, Wright G. Fear of needles--nature and prevalence in general practice. Aust Fam Physician. 2009 Mar;38(3):172-6. Taddio A, Chambers CT, Halperin SA, Ipp M, Lockett D, Rieder MJ, Shah V. Inadequate pain management during routine childhood immunizations: the nerve of it. Clin Ther. 2009;31 Suppl 2:S152-67. doi: 10.1016/j.clinthera.2009.07.022. Review.
Starting date: September 2015
Last updated: August 4, 2015
|