Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00150189
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : May 25, 2018
Children's Miracle Network
Information provided by (Responsible Party):
Milton S. Hershey Medical Center

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 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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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.

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 identifier (NCT number): NCT00150189

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
Principal Investigator: Linda A Hatfield, PhD(c) CNNP Penn State College of Medicine, Penn State Milton S. Hershey Medical Center'

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Milton S. Hershey Medical Center 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:
Procedural Pain

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs