Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations

This study has been completed.

Sponsor:

Collaborator:

Children's Miracle Network

Information provided by:

Penn State University

ClinicalTrials.gov Identifier:

NCT00150189

First received: September 6, 2005

Last updated: December 22, 2006

Last verified: December 2006

History of Changes

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Efficacy of Oral Sucrose Analgesia During Routine Immunizations at 6 Weeks and 4 Months of Age

Resource links provided by NLM:

Drug Information available for: Sucrose

U.S. FDA Resources

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 (Child)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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

Keywords provided by Penn State University:


Pain Procedural Pain Sucrose Infant Newborn

Additional relevant MeSH terms:


Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016

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