Thermal Analgesia in Newborns

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: warmth; Other: sucrose

• Registration Number: NCT00740298
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-01
• Study First Submitted: 2008-08-20
• Study First Submitted QC: 2008-08-21
• Study First Posted: 2008-08-22
• Primary Completion: 2018-04-26
• Study Completion: 2018-04-26
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• healthy infants

Exclusion Criteria

• unhealthy infants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	warmth	warmth
1	sucrose	Sweet Taste

Primary Outcome Measures

Name	Time	Method
Decreased behavioral and physiologic indicators of pain	5 minutes

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States