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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sucrose | Experimental | Participants received oral sucrose (0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine. |
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| Placebo | Placebo Comparator | Participants received Placebo (sterile water, 0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of oral Sucrose | Other | Participants received oral sucrose 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine. |
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| Measure | Description | Time Frame |
|---|---|---|
| Behavioral pain response | 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). | Baseline, and then at 2 and 5 minutes post DTaP, IPV, and Hep B vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda A Hatfield, PhD | The Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Pediatric Associates, Penn State Children's Hospital | Hershey | Pennsylvania | 17033 | United States |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Double Blind (subject, Investigator)
| Administration of oral Placebo | Other | Participants received Placebo 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine. |
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