Trials / Completed
CompletedNCT00150189
Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations
Efficacy of Oral Sucrose Analgesia During Routine Immunizations at 6 Weeks and 4 Months of Age
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (planned)
- Sponsor
- Milton S. Hershey Medical Center · Academic / Other
- Sex
- All
- Age
- 6 Weeks – 4 Months
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Sucrose |
Timeline
- Start date
- 2003-11-01
- Primary completion
- 2006-10-11
- Completion
- 2006-10-11
- First posted
- 2005-09-08
- Last updated
- 2018-05-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00150189. Inclusion in this directory is not an endorsement.