Pain Due to Certain Specified Procedures Clinical Trial
Official title:
Be Sweet to Toddlers During Needles: RCT of Sucrose Compared to Placebo
NCT number | NCT02151136 |
Other study ID # | 11/20E |
Secondary ID | |
Status | Terminated |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | July 2019 |
Verified date | November 2019 |
Source | Children's Hospital of Eastern Ontario |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 86 |
Est. completion date | July 2019 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Months to 36 Months |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Eastern Ontario |
Canada,
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. — View Citation
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. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | FLACC (Face, Legs, Arms, Crying, Consolability) | The FLACC score is a validated 10-point scale composite pain score. | FLACC scores will be completed before and during the procedure and up to one minute after the end of the venipuncture procedure | |
Secondary | MBPS (Modified Behavioural Pain Scale) | The MBPS is a validated 10-point scale composite pain score. | MBPS scores will be completed before and during the procedure and up to one minute after the end of the venipuncture procedure | |
Secondary | Child's compliance with intervention | The child's compliance with the study solution during venipuncture will be recorded by the research personnel on the data collection sheet as a 3-point scale (Fully compliant, Somewhat compliant, Not compliant) and will be scored and documented following completion of the procedure. The research personnel will ask the parent or nurse in attendance, what they consider the child's compliance score was. | up to one minute |
Status | Clinical Trial | Phase | |
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