We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Analgesic Properties of Oral Sucrose 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.
ClinicalTrials.gov Identifier: NCT00446875
Recruitment Status : Unknown
Verified March 2007 by Penn State University.
Recruitment status was:  Recruiting
First Posted : March 13, 2007
Last Update Posted : March 13, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations.

Condition or disease Intervention/treatment
Procedural Pain Procedure: Administration of oral sucrose

Detailed Description:

The purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations.

Acute pain during early life may alter infant pain responses, cognitive development and behavioral outcomes. Infants respond to immunizations with significant pain and distress. This study will examine the analgesic properties of oral sucrose and maternal holding in postnatal infants.

Comparison: Administration of oral sucrose, sterile water and maternal contact 2 minutes before routine immunizations.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of Oral Sucrose and Maternal Contact During Routine Immunizations in Postnatal Infants
Study Start Date : January 2007

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. Behavioral pain response; score on infant pain at 2 and 5 minutes

Eligibility Criteria

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:   3 Months to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Currently between 4 and 11 months of age;
  2. Between 37 and 42 weeks’ completed gestation at birth;
  3. Birth weight greater than 2.5 kg; and
  4. No evidence of acute or chronic disease

Exclusion Criteria:

  1. Fed 30 minutes prior to immunization;
  2. Received analgesic/sedative the day of the immunizations;
  3. Parent wishes to feed the infant during the immunizations;
  4. Infant is diagnosed with a major congenital disorder where the behavioral responses to painful stimuli may be altered; or
  5. 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): NCT00446875


Contacts
Contact: Linda A Hatfield, PhD 717 531-4159 lal153@psu.edu

Locations
United States, Pennsylvania
University Pediatric Associates, Penn State Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Linda A Hatfield, PhD         
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Linda A Hatfield, PhD The Penn State University
More Information

ClinicalTrials.gov Identifier: NCT00446875     History of Changes
Other Study ID Numbers: SeedHatfield
First Posted: March 13, 2007    Key Record Dates
Last Update Posted: March 13, 2007
Last Verified: March 2007

Keywords provided by Penn State University:
Pain
Procedural pain
Sucrose
Infant

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs