Condition category
Signs and Symptoms
Date applied
12/08/2005
Date assigned
14/09/2005
Last edited
25/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sarah Curtis

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SWEET Study

Study hypothesis

Pain scores will be significantly reduced for infants who either recieve sucrose, pacifier or both prior to venipuncture as compared to placebo

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Sucrose

Primary outcome measures

Score on the Faces Legs Arms Crying and Consolability (FLACC) Scale

Secondary outcome measures

Crying Time, Heart Rate

Overall trial start date

01/03/2004

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Any infant 0-6 months requiring venipuncture as part of their emergency department management

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

132

Participant exclusion criteria

Infants deemed too critically ill or otherwise ineligible at the discretion of the attending physician

Recruitment start date

01/03/2004

Recruitment end date

30/06/2005

Locations

Countries of recruitment

Canada

Trial participating centre

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

Sponsor information

Organisation

University of Alberta, Department of Pediatrics (Canada)

Sponsor details

Aberhart Centre One
11402 University Avenue
Edmonton
Alberta
T6G 2J3
Canada

Sponsor type

University/education

Website

http://www.med.ualberta.ca/pediatrics/

Funders

Funder type

University/education

Funder name

Department of Pediatrics, University of Alberta

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17640375

Publication citations

  1. Results

    Curtis SJ, Jou H, Ali S, Vandermeer B, Klassen T, A randomized controlled trial of sucrose and/or pacifier as analgesia for infants receiving venipuncture in a pediatric emergency department., BMC Pediatr, 2007, 7, 27, doi: 10.1186/1471-2431-7-27.

Additional files

Editorial Notes