None listed
Conditions
Brief 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
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 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.
Sponsors
Mater Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to 3 Months
Healthy volunteers
No
Inclusion criteria
parental consent, presenting to participating emergency departments, age 0-3 months , able to suckle / swallow, not critically ill.
Exclusion criteria
no consent , older than defined age, critically ill , unable to suckle, received sucrose in the previous 12 hours
Outcome results
None listed