Using Sugar Water to Relieve Pain in Infants

Not Applicable

• Conditions: Pain; Infant, Newborn; Diabetes

• Registration Number: NCT00213213
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study Completion: 2005-07
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Last Update Submitted: 2010-03-11
• Last Update Posted: 2010-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
- 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 Outcome Measures

Name	Time	Method
(safety):
(effectiveness):
- 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
- Incidence of vomiting during administration of sucrose
- Oxygen saturation during administration of sucrose
- Serum Glucose concentrations in infants of diabetic mothers

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada