Analgesic Properties of Oral Sucrose During Immunizations

Milton S. Hershey Medical Center98 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Procedural Pain

Interventions

Administration of oral SucroseOTHER

Participants received oral sucrose 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.

Administration of oral PlaceboOTHER

Participants received Placebo 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 11 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University Pediatric Associates, Penn State Children's Hospital

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

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).

Time frame: Baseline, and then at 2 and 5 minutes post DTaP, IPV, and Hep B vaccine

Data from ClinicalTrials.gov

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