Pain responses in infants born to diabetic mothers Signs and Symptoms Pain
Conditions
Interventions
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 ti
Sponsors
Hospital for Sick Children, Toronto (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada
Outcome results
None listed