Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pain; Procedural Pain	Behavioral: Sucrose	Not Applicable

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Enrollment :	140 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Efficacy of Oral Sucrose Analgesia During Routine Immunizations at 6 Weeks and 4 Months of Age
Study Start Date :	November 2003

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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 Outcome Measures :

1. Duration of analgesia during immunizations
2. Age related changes in behavioral pain response during immunizations

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	6 Weeks to 4 Months (Child)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	September 8, 2005
Last Update Posted:	December 25, 2006
Last Verified:	December 2006

Keywords provided by Penn State University:

Pain; Procedural Pain; Sucrose; Infant; Newborn

Additional relevant MeSH terms:

Vaccines; Immunologic Factors; Physiological Effects of Drugs