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

Plain Language Summary

Simplified for easier understanding

This study is comparing two different concentrations of sugar water (sucrose) — 24% and 66% — to see which one better reduces pain during minor medical procedures in very young babies. Sugar water is already known to help calm newborns during painful procedures like blood draws or IV insertions. Researchers want to know whether a stronger sugar solution works even better. You may be eligible if: - Your baby is between 0 and 3 months old - Your baby needs a minor medical procedure such as a blood test, IV line, or heel prick at a participating emergency department - Your baby is able to suckle and swallow - A parent or guardian provides written consent You may NOT be eligible if: - Your baby is older than 3 months - Your baby is critically ill - Your baby is unable to suckle - Your baby received sucrose in the previous 12 hours Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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ACTRN12610000260022