Overview

This trial is active, not recruiting.

Conditions pain, infant, newborn, diabetes
Treatment sucrose
Sponsor The Hospital for Sick Children
Collaborator Canadian Institutes of Health Research (CIHR)
Start date July 2003
End date July 2005
Trial size 240 participants
Trial identifier NCT00213213, 1000002771, CIHR MCT-63143, ISRCTN23411530

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
- 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)
time frame:

Secondary Outcomes

Measure
(effectiveness):
time frame:
- Effectiveness of sucrose for repeated heel lances
time frame:
- Effectiveness of sucrose in decreasing anticipatory pain responses during venipuncture
time frame:
- Effectiveness of sucrose in decreasing pain response during Vitamin K injection
time frame:
- Determination of relationship between painful procedures and infant response during routine care procedures
time frame:
(safety):
time frame:
- Incidence of vomiting during administration of sucrose
time frame:
- Oxygen saturation during administration of sucrose
time frame:
- Serum Glucose concentrations in infants of diabetic mothers
time frame:

Eligibility Criteria

Male or female participants up to 3 days old.

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

Additional Information

Official title Effectiveness of Sucrose Analgesia in Reducing Pain Responses in Infants Born to Diabetic and Non-diabetic Mothers: A Randomized Controlled Trial
Principal investigator Anna Taddio, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by The Hospital for Sick Children.