Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations

Not Applicable

Completed

• Conditions: Procedural Pain; Pain

• Registration Number: NCT00150189
• Lead Sponsor: Milton S. Hershey Medical Center

Brief 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

Study Timeline

• Study Start: 2003-11-01
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Primary Completion: 2006-10-11
• Study Completion: 2006-10-11
• Status Verified: 2006-12
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The University of Wisconsin Children's Hospital Pain Scale will measure the primary outcome acute behavioral pain response. Measure will be recorded at baseline, immediately after immunizations and 3 minutes following immunizations

Secondary Outcome Measures

Name	Time	Method
Age related changes in behavioral pain response during immunizations
Duration of analgesia during immunizations

Trial Locations

Locations (1)

General Ambulatory Pediatric Clinic, Penn State Children's Hospital; 🇺🇸 Hershey, Pennsylvania, United States