Clinical Trials Directory

Trials / Completed

CompletedNCT00150189

Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations

Efficacy of Oral Sucrose Analgesia During Routine Immunizations at 6 Weeks and 4 Months of Age

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
140 (planned)
Sponsor
Milton S. Hershey Medical Center · Academic / Other
Sex
All
Age
6 Weeks – 4 Months
Healthy volunteers
Accepted

Summary

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

Detailed description

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

Conditions

Interventions

TypeNameDescription
BEHAVIORALSucrose

Timeline

Start date
2003-11-01
Primary completion
2006-10-11
Completion
2006-10-11
First posted
2005-09-08
Last updated
2018-05-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00150189. Inclusion in this directory is not an endorsement.