Be Sweet to Toddlers: Does Sugar Water Reduce Pain During Blood Work?
NCT ID: NCT02151136
Last Updated: 2019-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
86 participants
INTERVENTIONAL
2015-11-30
2019-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial of an Oral Sucrose Solution Versus Placebo in Children 1 to 3 Months Old Needing Bladder Catheterization
NCT01544985
Effect on Pain of Oral Sucrose Versus Placebo in Children 1 to 3 Months Old Needing Venipuncture
NCT01293812
Sweet-Tasting Solution Versus Placebo to Reduce Pain During Local Anesthetic Injection in Children
NCT07279285
Rotavirus vs. Sucrose for Vaccine Injection Pain
NCT02174705
Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborns Undergoing Venipuncture
NCT00519207
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
24% sucrose
Standard care
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)
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
Sterile water
Standard care
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
24% sucrose
Sterile water
Standard care
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)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
12 Months
36 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Children's Hospital of Eastern Ontario
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Denise Harrison
Chair in Nursing Care of Children, Youth and Families
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Denise Harrison, RN, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Eastern Ontario
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1016/j.pmn.2004.09.002.
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. doi: 10.1177/1367493506066482.
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. doi: 10.1177/1367493504045822.
Cummings EA, Reid GJ, Finley AG, McGrath PJ, Ritchie JA. Prevalence and source of pain in pediatric inpatients. Pain. 1996 Nov;68(1):25-31. doi: 10.1016/S0304-3959(96)03163-6.
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. No abstract available.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11/20E
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.