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

March 9, 2007
March 9, 2007
January 2007
Not Provided
Behavioral pain response; score on infant pain at 2 and 5 minutes
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Analgesic Properties of Oral Sucrose During Immunizations
Efficacy of Oral Sucrose and Maternal Contact During Routine Immunizations in Postnatal Infants

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Procedural Pain
Procedure: Administration of oral sucrose
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
141
Not Provided
Not Provided

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.
Both
3 Months to 11 Months
Yes
Contact: Linda A Hatfield, PhD 717 531-4159 lal153@psu.edu
United States
 
NCT00446875
SeedHatfield
Yes
Not Provided
Penn State University
Not Provided
Principal Investigator: Linda A Hatfield, PhD The Penn State University
Penn State University
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP