Sucrose analgesia during needle related procedures in infants and young children

Does sucrose solution for infants, and lollypops for pre-school children 3-5 years of age, reduce pain during scheduled childhood immunisation in healthy children, and venepuncture in hospitalized children, compared to placebo (infants) and distraction (pre-school children).

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000355077

Enrollment

Registered

2010-05-04

Start date

2011-02-07

Completion date

2013-07-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Small amounts of sweet tasting sugar water reduces pain in babies during painful blood tests and injections. We do not know if sugar also reduces pain in toddlers and young children. This project will help to determine if small amounts of sugar water reduce pain in toddlers during their immunisations and venepuncture and if sucking on a lollypop helps to reduce pain in pre-school children between 3 and 5 years of age during their injections for immunisation. The immunisation part of this study will be done in the Royal Children’s Hospital Immunisation Centre where mothers and fathers bring their children in to have their scheduled childhood immunisations done. The part of the study examining sucrose efficacy in hospitalized toddlers during venepuncture will be conducted in Canada, at CHEO in a surgical ward.

Interventions

Immunisation Study: Infants: 2mL of 33% oral sucrose solution, given in 0.25 - 0.5mL alliquots; commencing 2 minutes prior to first injection (0.5mL), and repeating immediately prior to each injection (0.25mL). Pre-school children: Glucose lollypop (~8 grams glucose/lollypop) commencing sucking 2 minutes during prior to first immunisation, and continuing prior to each subsequent immunisation. Immunisations: 12 months: 3 injections Haemophilus influenzae type B (Hib: Hiberix) Measles, Mumps, Rubella (MMR: Priorix) Meningococcal C (NeisVacC) 18 months: 1 injection Varicella (Varilrix) 3-5 Years: 2 injections Diptheria, Tetanus, Pertussis, Inactivated Polio vaccine (Infanrix-IPV) MMR (Priorix) Venepuncture Study: Hospitalized todders aged 12 - 36 months requiring venepuncture will receive 2mL of 24% oral sucrose solution, given in 0.25 alliquots; commencing 2 minutes prior to needle insertion; repeating immediately prior to needle insertion, and given 2 minutely until completion of procedure.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

1 Years to 5 Years

Healthy volunteers

Yes

Inclusion criteria

Site 1: Infants/toddlers aged 12-18 months and pre-school children aged 3-5 years, undergoing scheduled childhood immunisation in the Royal Children’s Hospital Immunisation Centre. Site 2: Toddlers aged 12-36 months undergoing venepuncture in the Children's Hospital of Eastern Ontario surgical unit.

Exclusion criteria

Insufficient understanding of English If already eating/drinking sweet solutions or foods In addition for venepuncture study: If received muscle relaxants or opioid analgesics within preceeding 24 hours

Outcome results