Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations

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ClinicalTrials.gov Identifier: NCT00150189

Recruitment Status : Completed

First Posted : September 8, 2005

Last Update Posted : May 25, 2018

Sponsor:

Collaborator:

Children's Miracle Network

Information provided by (Responsible Party):

Milton S. Hershey Medical Center

Study Description

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


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
Actual Study Start Date :	November 1, 2003
Actual Primary Completion Date :	October 11, 2006
Actual Study Completion Date :	October 11, 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150189

Locations


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

Sponsors and Collaborators

Milton S. Hershey Medical Center

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.


Responsible Party:	Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:	NCT00150189 History of Changes
Other Study ID Numbers:	IRB NO. 2003-315
First Posted:	September 8, 2005 Key Record Dates
Last Update Posted:	May 25, 2018
Last Verified:	December 2006

Keywords provided by Milton S. Hershey Medical Center:


Pain Procedural Pain Sucrose Infant Newborn

Additional relevant MeSH terms:


Vaccines Immunologic Factors Physiological Effects of Drugs

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