NCT02151136|TerminatedPhase 4
Be Sweet to Toddlers: Does Sugar Water Reduce Pain During Blood Work?
Be Sweet to Toddlers During Needles: RCT of Sucrose Compared to Placebo
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Be Sweet to Toddlers During Needles: RCT of Sucrose Compared to Placebo
Sponsor study identifier
interventional
86
1 country
1
Study Start
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2019
Actual (reported)Study Completion
July 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 28, 2014
Actual (reported)May 30, 2014
Actual (reported)November 2015
Date type not reportedThis date has not been verified as actual or estimated.
July 2019
Actual (reported)July 2019
Actual (reported)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
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
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
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
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
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.
Denise Harrison, RN, PhD
Children's Hospital of Eastern Ontario
86 participants (actual enrollment reported by the registry).
First Submitted
May 28, 2014
First Posted
May 30, 2014
Study Start
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
Novel Cervical Retraction Device
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)
Contact the study team to confirm eligibility.
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.
Primary Completion
July 2019
Actual (reported)Study Completion
July 2019
Actual (reported)Last Updated
November 7, 2019
Record last verified: 2019-11
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