Efficacy of Oral Sucrose and Maternal Contact During Routine Immunizations in Postnatal Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Procedural Pain
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Behavioral pain response
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Behavioral pain response
Time Frame: Baseline, and then at 2 and 5 minutes post DTaP, IPV, and Hep B vaccine
Infants will be evaluated based on the University of Wisconsin Children's Hospital Pain Scale to score an infant's pain. Possible scores range from 0 (no pain) to 5 (worst possible pain).