Clinical trial NCT00150189: Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations
Official title: Efficacy of Oral Sucrose Analgesia During Routine Immunizations at 6 Weeks and 4 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Procedural Pain
Keywords: Pain
Procedural Pain
Sucrose
Infant
Newborn
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Children's Miracle Network
First posted: 2005-09-08
Enrollment: 140
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: 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:
measure: Duration of analgesia during immunizations
measure: Age related changes in behavioral pain response during immunizations
Other outcomes:
Locations:
city: Hershey
country: United States
facility: General Ambulatory Pediatric Clinic, Penn State Children's Hospital
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center'
name: Linda A Hatfield, PhD(c) CNNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hatfield LA, Gusic ME, Dyer AM, Polomano RC. Analgesic properties of oral sucrose during routine immunizations at 2 and 4 months of age. Pediatrics. 2008 Feb;121(2):e327-34. doi: 10.1542/peds.2006-3719.