Expired Study
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Hershey, Pennsylvania 17033


Purpose:

The study explores the potential benefits of a sugar water solution for decreasing pain in infants during routine immunizations.


Study summary:

Acute pain during early life may alter infant pain responses, cognitive development, and behavioral outcomes. Immunization injections represent a relatively brief exposure to acute pain, yet assessment studies demonstrate that infants respond with significant distress during the injections. This study will examine the analgesic potential of oral sucrose in diminishing the pain associated with immunization injections in 6 week to 4-month-old infants. The proposed mechanism of action is via the activation of endogenous opioids that attenuate nociceptive information at the level of the dorsal horn. Comparison: Administration of oral sucrose 2 minutes prior to immunizations compared to administration of sterile water 2 minutes prior to immunizations


Criteria:

Inclusion Criteria: - Currently between 2 and 4 months of age - Birth between 37 and 42 weeks' completed gestation; - Birth weight greater than 2.5 kg - No evidence of acute or chronic disease processes. Exclusion Criteria: - They are experiencing concurrent illness - They received an analgesic/sedative 6 hours prior to the office visit - The infant has breast fed 30 minutes prior to the visit or wishes to breast feed during or immediately after the immunization - The infant has been introduced to solid food - The infant may not receive a pacifier - The infant is diagnosed with a major congenital disorder where the behavioral responses to painful stimuli may be altered - Language barriers preclude the process of obtaining parental consent.


NCT ID:

NCT00150189


Primary Contact:

Principal Investigator
Linda A Hatfield, PhD(c) CNNP
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center'


Backup Contact:

N/A


Location Contact:

Hershey, Pennsylvania 17033
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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