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Thermal Analgesia in Newborns

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Larry Gray, University of Chicago
ClinicalTrials.gov Identifier:
NCT00740298
First received: August 20, 2008
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

Newborns routinely experience pain associated with invasive procedures such as blood sampling, immunization, vitamin K injection, or circumcision. Prevention of pain is both an ethical expectation and a professional imperative, as untreated pain has deleterious consequences including altered pain sensitivity in later childhood and may be related to the permanent neuroanatomical and behavioral abnormalities as found in animal models. Moreover, pain is a source of concern and distress for new parents. Yet, pain reducing therapies are often underused for the numerous minor procedures that are a part of routine medical and nursing care for neonates. Growing scientific and clinical literature provides evidence for the effectiveness of natural, non-pharmacological techniques in both animal and human newborns. This study compares the pain reliving effects of sweet taste to the combination of sweet taste and warmth.


Condition Intervention
Pain
 Other: sucrose
Other: warmth

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Thermal Analgesia in Newborns

Resource links provided by NLM:

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

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Decreased behavioral and physiologic indicators of pain [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2008
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Sweet Taste
 Other: sucrose
sweet taste
Active Comparator: 2
warmth
 Other: warmth
warmth

  Eligibility

Ages Eligible for Study:   up to 2 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy infants

Exclusion Criteria:

  • unhealthy infants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740298

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Lawrence A Gray, MD University of Chicago
  More Information

No publications provided

Responsible Party: Larry Gray, Assistant Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT00740298     History of Changes
Other Study ID Numbers: 15480A, 5K23HD049452
Study First Received: August 20, 2008
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
infants
undergoing
vaccinations

ClinicalTrials.gov processed this record on May 23, 2013