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OpenTrials
Completed

NCT Number: NCT00150189

Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations

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

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Key information

Age range

6 week–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Ambulatory Pediatric Clinic, Penn State Children's Hospital

Hershey, Pennsylvania, 17033, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sucrose

Behavioral

Primary outcomes

  1. 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

  1. Duration of analgesia during immunizations

  2. Age related changes in behavioral pain response during immunizations

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Children's Miracle Network

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 8, 2005
Registry last updated
May 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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