Back to resultsUtilization of Oral Sucrose to Decrease Pain in Infants During Immunizations
Primary Purpose
Pain, Procedural Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sucrose
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain, Procedural Pain, Sucrose, Infant, Newborn
Eligibility 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.
Sites / Locations
- General Ambulatory Pediatric Clinic, Penn State Children's Hospital
Outcomes
Primary Outcome Measures
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
Duration of analgesia during immunizations
Age related changes in behavioral pain response during immunizations
Full Information
NCT ID
NCT00150189
First Posted
September 6, 2005
Last Updated
May 23, 2018
Sponsor
Milton S. Hershey Medical Center
Collaborators
Children's Miracle Network
1. Study Identification
Unique Protocol Identification Number
NCT00150189
Brief Title
Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations
Official Title
Efficacy of Oral Sucrose Analgesia During Routine Immunizations at 6 Weeks and 4 Months of Age
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
November 1, 2003 (Actual)
Primary Completion Date
October 11, 2006 (Actual)
Study Completion Date
October 11, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Children's Miracle Network
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural Pain
Keywords
Pain, Procedural Pain, Sucrose, Infant, Newborn
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
140 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Sucrose
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Duration of analgesia during immunizations
Title
Age related changes in behavioral pain response during immunizations
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda A Hatfield, PhD(c) CNNP
Organizational Affiliation
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center'
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Ambulatory Pediatric Clinic, Penn State Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18245406
Citation
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.
Results Reference
derived
Learn more about this trial
Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations
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