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Using Sugar Water to Relieve Pain in Infants

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ClinicalTrials.gov Identifier: NCT00213213
Recruitment Status : Unknown
Verified September 2005 by The Hospital for Sick Children.
Recruitment status was:  Active, not recruiting
First Posted : September 21, 2005
Last Update Posted : March 15, 2010
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Pain Infant, Newborn Diabetes Drug: Sucrose Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : July 2003
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose




Primary Outcome Measures :
  1. - 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 :
  1. (effectiveness):
  2. - Effectiveness of sucrose for repeated heel lances
  3. - Effectiveness of sucrose in decreasing anticipatory pain responses during venipuncture
  4. - Effectiveness of sucrose in decreasing pain response during Vitamin K injection
  5. - Determination of relationship between painful procedures and infant response during routine care procedures
  6. (safety):
  7. - Incidence of vomiting during administration of sucrose
  8. - Oxygen saturation during administration of sucrose
  9. - Serum Glucose concentrations in infants of diabetic mothers


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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 15, 2010
Last Verified: September 2005

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