Be Sweet to Toddlers: Does Sugar Water Reduce Pain During Blood Work?

NCT02151136 | Terminated Phase 4

• 1 other identifier: 11/20E
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Due to Certain Specified Procedures

Keywords

Sucrose; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

24% sucrose + standard care

EXPERIMENTAL

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

Drug: 24% sucrose; Other: Standard care

Sterile water + standard care

PLACEBO COMPARATOR

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

Drug: Sterile water; Other: Standard care

Interventions

24% sucrose DRUG

Also known as: TootSweet (NPN 80021492), DandleLion Kisses (NPN 80075819)

24% sucrose + standard care

Sterile water DRUG

Sterile water + standard care

Standard care OTHER

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)

24% sucrose + standard care; Sterile water + standard care

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (10)

• 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.

  PMID: 15616484 BACKGROUND

• 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.

  PMID: 1614786 BACKGROUND

• 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.

  PMID: 16940344 BACKGROUND

• 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.

  PMID: 15358886 BACKGROUND

• 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.

  PMID: 9251995 BACKGROUND

• 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.

  PMID: 21464171 BACKGROUND

• 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.

  PMID: 18446107 BACKGROUND

• 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.

  PMID: 21098062 BACKGROUND

• 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.

  PMID: 19283260 BACKGROUND

• 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.

  PMID: 19781434 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Sucrose; Standard of Care

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Denise Harrison, RN, PhD

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair in Nursing Care of Children, Youth and Families

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: November 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: November 7, 2019

Record last verified: 2019-11

Locations

CA (1)