Sucrose as Procedural Analgesia for Infants Receiving Venipuncture in a Pediatric Emergency Department

ISRCTN	ISRCTN15819627
DOI	https://doi.org/10.1186/ISRCTN15819627
Protocol serial number	N/A
Sponsor	University of Alberta, Department of Pediatrics (Canada)
Funder	Department of Pediatrics, University of Alberta

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Sarah Curtis
Scientific

Room 7217B, Second Floor
Aberhart Centre One
Edmonton, Alberta
T6G 2J3
Canada

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SWEET Study
Study objectives	Pain scores will be significantly reduced for infants who either recieve sucrose, pacifier or both prior to venipuncture as compared to placebo
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Pain
Intervention	Patients are randomly assigned to one of four groups as follows: a. Sucrose orally (PO) b. Sucrose PO & pacifier c. Placebo PO d. Placebo PO & pacifier
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Sucrose
Primary outcome measure(s)	Score on the Faces Legs Arms Crying and Consolability (FLACC) Scale
Key secondary outcome measure(s)	Crying Time, Heart Rate
Completion date	30/06/2005

Participant type(s)	Patient
Age group	Child
Lower age limit	0 Months
Upper age limit	6 Months
Sex	All
Target sample size at registration	132
Key inclusion criteria	Any infant 0-6 months requiring venipuncture as part of their emergency department management
Key exclusion criteria	Infants deemed too critically ill or otherwise ineligible at the discretion of the attending physician
Date of first enrolment	01/03/2004
Date of final enrolment	30/06/2005

Room 7217B, Second Floor

Edmonton, Alberta
T6G 2J3
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	18/07/2007		Yes	No