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NCT00740298 Clinical Trial

Thermal Analgesia in Newborns

Pain Clinical Trial

Official title:
Thermal Analgesia in Newborns

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00740298
Other study ID # 15480A
Secondary ID 5K23HD049452
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2008
Est. completion date April 26, 2018

Study information
Verified date April 2023
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 178
Est. completion date April 26, 2018
Est. primary completion date April 26, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 2 Days
Eligibility Inclusion Criteria: - healthy infants Exclusion Criteria: - unhealthy infants

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• sucrose
sweet taste
• warmth
warmth

Locations
Country Name City State
United States The University of Chicago Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
University of Chicago Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Decreased behavioral and physiologic indicators of pain 5 minutes
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