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Analgesic Properties of Oral Sucrose During Immunizations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Penn State University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00446875
First received: March 9, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Oral Sucrose and Maternal Contact During Routine Immunizations in Postnatal Infants

Resource links provided by NLM:

Drug Information available for: Sucrose
U.S. FDA Resources

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:

  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
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

No publications provided

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

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

ClinicalTrials.gov processed this record on May 16, 2013