Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations

Milton S. Hershey Medical Center140 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

140

Conditions

Pain Procedural Pain

Interventions

SucroseBEHAVIORAL

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 4 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

General Ambulatory Pediatric Clinic, Penn State Children's Hospital

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

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 Outcomes

Duration of analgesia during immunizations

Age related changes in behavioral pain response during immunizations

Data from ClinicalTrials.gov

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