Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations - Full Text View

Sponsors and Collaborators:	Penn State University Children's Miracle Network
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00150189

Purpose

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

Condition	Intervention
Pain Procedural Pain	Behavioral: Sucrose

MedlinePlus related topics: Childhood Immunization

Drug Information available for: Sucrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Oral Sucrose Analgesia During Routine Immunizations at 6 Weeks and 4 Months of Age

Further study details as provided by Penn State University:

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

Estimated Enrollment:	140
Study Start Date:	November 2003

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

Eligibility

Ages Eligible for Study:	6 Weeks to 4 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150189

Locations

United States, Pennsylvania
General Ambulatory Pediatric Clinic, Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033

Sponsors and Collaborators

Penn State University

Children's Miracle Network

Investigators

Principal Investigator:

Linda A Hatfield, PhD(c) CNNP

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center’

More Information

Publications indexed to this study:

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.

Study ID Numbers:	IRB NO. 2003-315
Study First Received:	September 6, 2005
Last Updated:	December 22, 2006
ClinicalTrials.gov Identifier:	NCT00150189
Health Authority:	United States: Institutional Review Board

Keywords provided by Penn State University:

Pain
Procedural Pain
Sucrose
Infant
Newborn

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on January 16, 2009