Effectiveness of sucrose analgesia in reducing pain responses in infants born to diabetic and non-diabetic mothers: A randomized controlled trial

ISRCTN	ISRCTN23411530
DOI	https://doi.org/10.1186/ISRCTN23411530
ClinicalTrials.gov (NCT)	NCT00213213
Protocol serial number	MCT-63143
Sponsor	Hospital for Sick Children, Toronto (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63143)

Submission date: 15/08/2005
Registration date: 15/08/2005
Last edited: 28/01/2019

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 Anna Taddio
Scientific

Department of Pharmacy
Hospital for Sick Children
555 University Avenue
Toronto, Ontario
M5G 1X8
Canada

Phone	+1 416 813 6235
Email	anna.taddio@sickkids.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Effectiveness of sucrose analgesia in reducing pain responses in infants born to diabetic and non-diabetic mothers: A randomized controlled trial
Study objectives	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(s)	Mount Sinai Hospital Research Ethics Board 17/06/2003
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Sucrose
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/07/2006

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	240
Key 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.
Key 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
Date of first enrolment	01/07/2003
Date of final enrolment	31/07/2006

Locations

Countries of recruitment

Canada

Study participating centre

Department of Pharmacy

Toronto, Ontario
M5G 1X8
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/07/2008	28/01/2019	Yes	No

Editorial Notes

28/01/2019: Publication reference added