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
1 other identifier
interventional
140
1 country
1
Brief Summary
The study explores the potential benefits of a sugar water solution for decreasing pain in infants during routine immunizations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Nov 2003
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2006
CompletedMay 25, 2018
December 1, 2006
2.9 years
September 6, 2005
May 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Duration of analgesia during immunizations
Age related changes in behavioral pain response during immunizations
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Milton S. Hershey Medical Centerlead
- Children's Miracle Networkcollaborator
Study Sites (1)
General Ambulatory Pediatric Clinic, Penn State Children's Hospital
Hershey, Pennsylvania, 17033, United States
Related Publications (1)
Hatfield LA, Gusic ME, Dyer AM, Polomano RC. Analgesic properties of oral sucrose during routine immunizations at 2 and 4 months of age. Pediatrics. 2008 Feb;121(2):e327-34. doi: 10.1542/peds.2006-3719.
PMID: 18245406DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linda A Hatfield, PhD(c) CNNP
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center'
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
November 1, 2003
Primary Completion
October 11, 2006
Study Completion
October 11, 2006
Last Updated
May 25, 2018
Record last verified: 2006-12