Using Sugar Water to Relieve Pain in Infants

NCT00213213 | Unknown

• 3 other identifiers: 1000002771CIHR MCT-63143ISRCTN23411530
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Infant, Newborn; Diabetes

Keywords

sucrose; analgesia; pain; neonates; diabetes

Outcome Measures

Primary Outcomes (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 Outcomes (9)

• (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

Interventions

Sucrose DRUG

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (1)

• Taddio A, Shah V, Hancock R, Smith RW, Stephens D, Atenafu E, Beyene J, Koren G, Stevens B, Katz J. Effectiveness of sucrose analgesia in newborns undergoing painful medical procedures. CMAJ. 2008 Jul 1;179(1):37-43. doi: 10.1503/cmaj.071734.

  PMID: 18591525 DERIVED

MeSH Terms

Conditions

Pain; Diabetes Mellitus; Agnosia

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Anna Taddio, PhD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: July 1, 2003
• Study Completion: July 1, 2005
• Last Updated: March 15, 2010

Record last verified: 2005-09

Locations

CA (1)