Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations

May 23, 2018 updated by: Milton S. Hershey Medical Center

Efficacy of Oral Sucrose Analgesia During Routine Immunizations at 6 Weeks and 4 Months of Age

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 4 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Duration of analgesia during immunizations
Age related changes in behavioral pain response during immunizations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

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'

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2003

Primary Completion (Actual)

October 11, 2006

Study Completion (Actual)

October 11, 2006

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Actual)

May 25, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB NO. 2003-315

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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