Thermal Analgesia in Newborns
This trial is active, not recruiting.
|Sponsor||University of Chicago|
|Start date||July 2008|
|End date||July 2013|
|Trial size||30 participants|
|Trial identifier||NCT00740298, 15480A, 5K23HD049452|
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.
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
|Primary purpose||supportive care|
Decreased behavioral and physiologic indicators of pain
time frame: 5 minutes
Male or female participants up to 2 days old.
Inclusion Criteria: - healthy infants Exclusion Criteria: - unhealthy infants
|Official title||Thermal Analgesia in Newborns|
|Principal investigator||Lawrence A Gray, MD|
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