Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations

Pain Clinical Trial

Official title:

Efficacy of Oral Sucrose Analgesia During Routine Immunizations at 6 Weeks and 4 Months of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150189
• Other study ID #: IRB NO. 2003-315
• Status: Completed
• Phase: N/A
• Start date: November 1, 2003
• Est. completion date: October 11, 2006

Study information

• Verified date: December 2006
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 11, 2006
• Est. primary completion date: October 11, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 4 Months

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Procedural Pain

Intervention

Behavioral:
• Sucrose

Locations

Country	Name	City	State
United States	General Ambulatory Pediatric Clinic, Penn State Children's Hospital	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Children's Miracle Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of analgesia during immunizations
Secondary	Age related changes in behavioral pain response during immunizations