Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations

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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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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