Analgesic Properties of Oral Sucrose During Immunizations

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Efficacy of Oral Sucrose and Maternal Contact During Routine Immunizations in Postnatal Infants

Conditions
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Procedural Pain

Intervention / Treatment
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* Other: Administration of oral Sucrose
* Other: Administration of oral Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 11 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sucrose<br>Participants received oral sucrose (0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine. | Other: Administration of oral Sucrose<br>* Participants received oral sucrose 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.<br>|
| Placebo Comparator: Placebo<br>Participants received Placebo (sterile water, 0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine. | Other: Administration of oral Placebo<br>* Participants received Placebo 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.<br>* Other names: sterile water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

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