RecruitingACTRN12610000260022

The sucrose study - A comparison of 24% versus 66% sugar to control procedural pain in new borns and young children

24% versus 66% sucrose to control procedural pain in neonates and young children- a randomized controlled trial


Sponsor

Mater Children's Hospital

Enrollment

80 participants

Start Date

Nov 1, 2009

Study Type

Interventional

Conditions

Summary

Children aged 0-3 month presenting to a participating emergency department and have been found to require medically indicated interventions ( placement of an intravenous access device, phlebotomy, heel prick) are enrolled after parental consent. After consent , patients will receive 1 ml of a study drug ( either 1 ml of 24% sucrose or 1ml of 66% sucrose). This is offered by a nurse to the infant who is encouraged to suckle on a pacifier or glove and is swaddled by a parent or caregiver at the same time. 2 minutes after the sucrose commenced, the procedure commences. During the procedure the attending nurse scores the maximum pain response as measured by Alder Hey pain score


Eligibility

Sex: Both males and femalesMin Age: 0 MonthssMax Age: 3 Monthss

Inclusion Criteria1

  • parental consent, presenting to participating emergency departments, age 0-3 months , able to suckle / swallow, not critically ill.

Exclusion Criteria1

  • no consent , older than defined age, critically ill , unable to suckle, received sucrose in the previous 12 hours

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

1 ml of 66% oral sucrose as a single dose is offered to the infant prior to the procedure and if sucrose remains, throughout the procedure. The speed of giving the sucrose depends on the infants eager

1 ml of 66% oral sucrose as a single dose is offered to the infant prior to the procedure and if sucrose remains, throughout the procedure. The speed of giving the sucrose depends on the infants eagerness to suckle. Most infants are expected to suckle the whole amount of sucrose within 30-60 seconds.The procedure commences EXACTLY 2 minutes after the giving of sucrose commences.


Locations(1)

New Zealand

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12610000260022