Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations

Study Overview
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Brief Summary
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The study explores the potential benefits of a sugar water solution for decreasing pain in infants during routine immunizations.

Detailed Description
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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

Official Title
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Efficacy of Oral Sucrose Analgesia During Routine Immunizations at 6 Weeks and 4 Months of Age

Conditions
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Pain, Procedural Pain

Intervention / Treatment
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* Behavioral: Sucrose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Sucrose|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of analgesia during immunizations |  |  | 
| Age related changes in behavioral pain response during immunizations |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Procedural Pain, Sucrose, Infant, Newborn