Diabetes, Infant, Newborn, Pain
Conditions
Keywords
sucrose, analgesia, pain, neonates, diabetes
Brief summary
This study will examine the safety and effectiveness of sugar water to relieve pain in newborn infants during painful blood tests and injections. Infants of diabetic mothers who receive repeated blood tests will be compared to infants of healthy mothers who receive routine painful procedures. We believe that administration of sucrose analgesia for every painful cutaneous procedure performed after delivery will result in less pain during the newborn infant screening test.
Interventions
DRUGSucrose
Sponsors
Canadian Institutes of Health Research (CIHR)
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Days
Healthy volunteers
No
Inclusion criteria
* healthy newborn infants ≥36 weeks gestation * infants born to mothers with diabetes (type 1, type 2, or gestational diabetes that is diet-controlled or insulin-dependent)and infants born to mothers without diabetes
Exclusion criteria
* Admission to the neonatal intensive care unit * plan to undergo circumcision during the study period * major congenital or neurological anomalies * clinical diagnosis of birth asphyxia or seizures * receiving analgesics or sedatives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Infant pain score during the newborn screening test, assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP (facial grimace, heart rate, oxygen saturation) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Effectiveness of sucrose for repeated heel lances | — |
| - Effectiveness of sucrose in decreasing anticipatory pain responses during venipuncture | — |
| - Effectiveness of sucrose in decreasing pain response during Vitamin K injection | — |
| - Determination of relationship between painful procedures and infant response during routine care procedures | — |
| (effectiveness): | — |
| - Incidence of vomiting during administration of sucrose | — |
| - Oxygen saturation during administration of sucrose | — |
| - Serum Glucose concentrations in infants of diabetic mothers | — |
| (safety): | — |
Countries
Canada
Outcome results
None listed