Analgesic Properties of Oral Sucrose During Immunizations - Full Text View

Sponsored by:	Penn State University
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00446875

Purpose

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	Intervention
Procedural Pain	Procedure: Administration of oral sucrose

MedlinePlus related topics: Childhood Immunization

Drug Information available for: Sucrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Oral Sucrose and Maternal Contact During Routine Immunizations in Postnatal Infants

Further study details as provided by Penn State University:

Primary Outcome Measures:

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

Estimated Enrollment:	141
Study Start Date:	January 2007

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.

Eligibility

Ages Eligible for Study:	3 Months to 11 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Fed 30 minutes prior to immunization;
Received analgesic/sedative the day of the immunizations;
Parent wishes to feed the infant during the immunizations;
Infant is diagnosed with a major congenital disorder where the behavioral responses to painful stimuli may be altered; or
Language barriers preclude the process of obtaining parental consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	SeedHatfield
Study First Received:	March 9, 2007
Last Updated:	March 9, 2007
ClinicalTrials.gov Identifier:	NCT00446875
Health Authority:	United States: Institutional Review Board

Keywords provided by Penn State University:

Pain
Procedural pain
Sucrose
Infant

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on January 16, 2009