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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 : December 25, 2006
Information provided by:

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
Pain Procedural Pain Behavioral: Sucrose

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)
Estimated 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

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 :
  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

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

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

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
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):
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: December 25, 2006
Last Verified: December 2006

Keywords provided by Penn State University:
Procedural Pain

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs