Condition category
Signs and Symptoms
Date applied
15/08/2005
Date assigned
15/08/2005
Last edited
18/04/2008
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 Anna Taddio

ORCID ID

Contact details

Department of Pharmacy
Hospital for Sick Children
555 University Avenue
Toronto
Ontario
M5G 1X8
Canada
+1 416 813 6235
anna.taddio@sickkids.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00213213

Protocol/serial number

MCT-63143

Study information

Scientific title

Acronym

Study hypothesis

1. Administration of sucrose analgesia for every painful cutaneous procedure performed after delivery will result in less pain during the newborn infant screening test performed by venipuncture prior to hospital discharge
2. Sucrose analgesia for every painful cutaneous procedure will decrease pain responses in infants undergoing repeated heel lancing
3. Administration of sucrose for every painful procedure will not be associated with adverse effects
4. Administration of sucrose for every painful procedure will decrease anticipatory pain responses during venipuncture for the newborn screening test
5. There is a relationship between previous painful procedures and infant response during routine care procedures

Ethics approval

Mount Sinai Hospital Research Ethics Board 17/06/2003

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Pain responses in infants born to diabetic mothers

Intervention

Group 1: 2 ml of 24% sucrose (weight/vol) 2 minutes prior to all noxious tissue-damaging cutaneous procedures
Group 2: 2 ml of sterile water (placebo) 2 minutes prior to all noxious tissue-damaging cutaneous procedures

Intervention type

Drug

Phase

Not Specified

Drug names

Sucrose

Primary outcome measures

Infant pain score during venipuncture for the newborn screening test, as assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP if there is divergence in response between parameters.

Secondary outcome measures

Secondary outcomes (effectiveness):
1. Effectiveness of sucrose for repeated heel lances
2. Effectiveness of sucrose in decreasing anticipatory pain responses during venipuncture
3. Determination of relationship between painful procedures and infant response during routine care procedures

Secondary outcomes (safety):
1. Incidence of vomiting during drug administration
2. Oxygen saturation during drug administration
3. Serum Glucose concentrations in infants of diabetic mothers

Overall trial start date

01/07/2003

Overall trial end date

31/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Include healthy newborn infants ≥36 weeks gestation (either sex). There are 2 study strata: infants born to mothers with diabetes (type 1, type 2, or gestational diabetes that is diet-controlled or insulin-dependent), and infants born to non-diabetes mothers with uneventful pregnancies.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Admission to the neonatal intensive care unit (NICU)
2. Plan to undergo circumcision during the study period
3. Major congenital or neurological anomalies
4. Clinical diagnosis of birth asphyxia or seizures
5. Receiving analgesics or sedatives

Recruitment start date

01/07/2003

Recruitment end date

31/07/2006

Locations

Countries of recruitment

Canada

Trial participating centre

Department of Pharmacy
Toronto, Ontario
M5G 1X8
Canada

Sponsor information

Organisation

Hospital for Sick Children, Toronto (Canada)

Sponsor details

555 University Avenue
Toronto
Ontario
M5G 1X8
Canada

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63143)

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

Publication citations

Additional files

Editorial Notes