Procedural Pain
Conditions
Keywords
Pain, Procedural pain, Sucrose, Infant
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.
Interventions
OTHERAdministration of oral Sucrose
Participants received oral sucrose 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.
OTHERAdministration of oral Placebo
Participants received Placebo 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind (subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to 11 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral pain response | 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). |
Countries
United States
Outcome results
None listed