Status:
COMPLETED
Jet Injection of 1% Buffered Lidocaine Versus Topical ELA-Max for Anesthesia Prior to Intravenous (IV) Catheterization in Children
Lead Sponsor:
Norton Healthcare
Conditions:
Pain
Eligibility:
All Genders
8-15 years
Phase:
PHASE4
Brief Summary
This trial is a comparison of the anesthetic effectiveness of J-Tip needle-free jet injection of 1% buffered lidocaine to the anesthetic effectiveness of topical 4% ELA-Max for peripheral intravenous ...
Detailed Description
A prospective, block-randomized, controlled trial comparing J-Tip jet injection of 1% buffered lidocaine to a 30-minute application of 4% ELA-Max for topical anesthesia in children 8-15 years old pres...
Eligibility Criteria
Inclusion
- Between the ages of 8-15 years requiring a PIV as part of their management in the emergency department.
Exclusion
- Excluded from the study if they reported use of analgesic medication within 6 hours of enrollment,
- Had a Glasgow Coma Score \< 15,
- A baseline screening VAS pain score \> 20 mm, or
- A history of skin hypersensitivity or lidocaine allergy,
- Were incapable of self-reporting a pain score,
- Had a known neurological condition that alters pain perception,
- Had methemoglobinemia, or
- Did not speak or understand English.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00444756
Start Date
April 1 2005
End Date
April 1 2006
Last Update
March 8 2007
Active Locations (1)
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1
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202