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Thermal Analgesia in Newborns

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ClinicalTrials.gov Identifier: NCT00740298
Recruitment Status : Unknown
Verified October 2013 by University of Chicago.
Recruitment status was:  Active, not recruiting
First Posted : August 22, 2008
Last Update Posted : October 9, 2013
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Other: sucrose Other: warmth Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Thermal Analgesia in Newborns
Study Start Date : July 2008
Actual Primary Completion Date : July 2013
Estimated Study Completion Date : July 2014

Arm Intervention/treatment
Active Comparator: 1
Sweet Taste
Other: sucrose
sweet taste
Active Comparator: 2
warmth
Other: warmth
warmth



Primary Outcome Measures :
  1. Decreased behavioral and physiologic indicators of pain [ Time Frame: 5 minutes ]


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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy infants

Exclusion Criteria:

  • unhealthy infants

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): 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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00740298     History of Changes
Other Study ID Numbers: 15480A
5K23HD049452 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013

Keywords provided by University of Chicago:
infants
undergoing
vaccinations