Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations

Penn State Health

Status

Completed

Conditions

Pain

Procedural Pain

Treatments

Behavioral: Sucrose

Study type

Interventional

Funder types

Other

Identifiers

NCT00150189

IRB NO. 2003-315

Details and patient eligibility

About

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

Full description

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

Sex

All

Ages

6 weeks to 4 months old

Volunteers

Accepts Healthy Volunteers

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.