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
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