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Using Sugar Water to Relieve Pain in Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by The Hospital for Sick Children.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00213213
First received: September 13, 2005
Last updated: March 11, 2010
Last verified: September 2005
History of Changes
  Purpose

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.


Condition Intervention
Pain
Infant, Newborn
Diabetes
 Drug: Sucrose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effectiveness of Sucrose Analgesia in Reducing Pain Responses in Infants Born to Diabetic and Non-diabetic Mothers: A Randomized Controlled Trial

Resource links provided by NLM:

Drug Information available for: Sucrose
U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • - 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:
  • (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
  • (safety):
  • - Incidence of vomiting during administration of sucrose
  • - Oxygen saturation during administration of sucrose
  • - Serum Glucose concentrations in infants of diabetic mothers

Estimated Enrollment: 240
Study Start Date: July 2003
Estimated Study Completion Date: July 2005
  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213213

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Anna Taddio, PhD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Anna Taddio/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00213213     History of Changes
Other Study ID Numbers: 1000002771, CIHR MCT-63143, ISRCTN23411530
Study First Received: September 13, 2005
Last Updated: March 11, 2010
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
sucrose
analgesia
pain
neonates
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013