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

Not Applicable

Completed

• Conditions: Pain responses in infants born to diabetic mothers; Signs and Symptoms; Pain

• Registration Number: ISRCTN23411530
• Lead Sponsor: Hospital for Sick Children, Toronto (Canada)

Brief Summary

1. 2008 results in https://www.ncbi.nlm.nih.gov/pubmed/18591525 (added 28/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-15
• Study Completion: 2006-07-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

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

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> Secondary outcomes (effectiveness):<br> 1. Effectiveness of sucrose for repeated heel lances<br> 2. Effectiveness of sucrose in decreasing anticipatory pain responses during venipuncture<br> 3. Determination of relationship between painful procedures and infant response during routine care procedures<br><br> Secondary outcomes (safety):<br> 1. Incidence of vomiting during drug administration<br> 2. Oxygen saturation during drug administration<br> 3. Serum Glucose concentrations in infants of diabetic mothers<br>