Thermal Analgesia in Newborns

The University of Chicago

Status: Completed

Conditions: Pain

Treatments: Other: sucrose; Other: warmth

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00740298

15480A

5K23HD049452 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: All

Ages: Under 2 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy infants

Exclusion criteria

• unhealthy infants

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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178 participants in 2 patient groups

1

Active Comparator group

Description:

Sweet Taste

Treatment:

Other: sucrose

2

Active Comparator group

Description:

warmth

Treatment:

Other: warmth