Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations
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ClinicalTrials.gov Identifier: NCT00150189 |
Recruitment Status
:
Completed
First Posted
: September 8, 2005
Last Update Posted
: December 25, 2006
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain Procedural Pain | Behavioral: Sucrose | Not Applicable |
Acute pain during early life may alter infant pain responses, cognitive development, and behavioral outcomes. Immunization injections represent a relatively brief exposure to acute pain, yet assessment studies demonstrate that infants respond with significant distress during the injections. This study will examine the analgesic potential of oral sucrose in diminishing the pain associated with immunization injections in 6 week to 4-month-old infants. The proposed mechanism of action is via the activation of endogenous opioids that attenuate nociceptive information at the level of the dorsal horn.
Comparison: Administration of oral sucrose 2 minutes prior to immunizations compared to administration of sterile water 2 minutes prior to immunizations
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Oral Sucrose Analgesia During Routine Immunizations at 6 Weeks and 4 Months of Age |
Study Start Date : | November 2003 |

- The University of Wisconsin Children’s Hospital Pain Scale will measure the primary outcome acute behavioral pain response. Measure will be recorded at baseline, immediately after immunizations and 3 minutes following immunizations
- Duration of analgesia during immunizations
- Age related changes in behavioral pain response during immunizations

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Ages Eligible for Study: | 6 Weeks to 4 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Currently between 2 and 4 months of age
- Birth between 37 and 42 weeks’ completed gestation;
- Birth weight greater than 2.5 kg
- No evidence of acute or chronic disease processes.
Exclusion Criteria:
- They are experiencing concurrent illness
- They received an analgesic/sedative 6 hours prior to the office visit
- The infant has breast fed 30 minutes prior to the visit or wishes to breast feed during or immediately after the immunization
- The infant has been introduced to solid food
- The infant may not receive a pacifier
- The infant is diagnosed with a major congenital disorder where the behavioral responses to painful stimuli may be altered
- Language barriers preclude the process of obtaining parental consent.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150189
United States, Pennsylvania | |
General Ambulatory Pediatric Clinic, Penn State Children's Hospital | |
Hershey, Pennsylvania, United States, 17033 |
Principal Investigator: | Linda A Hatfield, PhD(c) CNNP | Penn State College of Medicine, Penn State Milton S. Hershey Medical Center’ |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00150189 History of Changes |
Other Study ID Numbers: |
IRB NO. 2003-315 |
First Posted: | September 8, 2005 Key Record Dates |
Last Update Posted: | December 25, 2006 |
Last Verified: | December 2006 |
Keywords provided by Penn State University:
Pain Procedural Pain Sucrose Infant Newborn |
Additional relevant MeSH terms:
Vaccines Immunologic Factors Physiological Effects of Drugs |