Overview

This trial is active, not recruiting.

Condition pain
Treatments sucrose, warmth
Sponsor University of Chicago
Start date July 2008
End date July 2013
Trial size 30 participants
Trial identifier NCT00740298, 15480A, 5K23HD049452

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(Active Comparator)
Sweet Taste
sucrose
sweet taste
(Active Comparator)
warmth
warmth
warmth

Primary Outcomes

Measure
Decreased behavioral and physiologic indicators of pain
time frame: 5 minutes

Eligibility Criteria

Male or female participants up to 2 days old.

Inclusion Criteria: - healthy infants Exclusion Criteria: - unhealthy infants

Additional Information

Official title Thermal Analgesia in Newborns
Principal investigator Lawrence A Gray, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by University of Chicago.