Sucrose as Procedural Analgesia for Infants Receiving Venipuncture in a Pediatric Emergency Department
| ISRCTN | ISRCTN15819627 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15819627 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/08/2005
- Registration date
- 14/09/2005
- Last edited
- 25/07/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sarah Curtis
Scientific
Scientific
Room 7217B, Second Floor
Aberhart Centre One
Edmonton, Alberta
T6G 2J3
Canada
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sucrose |
| Primary outcome measure | Score on the Faces Legs Arms Crying and Consolability (FLACC) Scale |
| Secondary outcome measures | Crying Time, Heart Rate |
| Overall study start date | 01/03/2004 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 0 Months |
| Upper age limit | 6 Months |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Canada
Study participating centre
Room 7217B, Second Floor
Edmonton, Alberta
T6G 2J3
Canada
T6G 2J3
Canada
Sponsor information
University of Alberta, Department of Pediatrics (Canada)
University/education
University/education
Aberhart Centre One
11402 University Avenue
Edmonton, Alberta
T6G 2J3
Canada
| Website | http://www.med.ualberta.ca/pediatrics/ |
|---|---|
"ROR" |
https://ror.org/0160cpw27 |
Funders
Funder type
University/education
Department of Pediatrics, University of Alberta
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results: | 18/07/2007 | Yes | No |
