Jet Injection of 1% Buffered Lidocaine Versus Topical ELA-Max for Anesthesia Prior to Intravenous (IV) Catheterization in Children

Completed · Phase 4

Conditions studied: Pain

In brief

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 catheter (PIV) insertion. The researchers hypothesize that the jet injection of lidocaine will provide superior anesthesia to the ELA-Max prior to PIV insertion.

Key facts

Study ID

NCT00444756

Run by

Norton Healthcare

People needed

70

Starts

2005-04-01

Expected to finish

2006-04-01

Last updated by the study team

2007-03-08

Who can join

Age: 8 and older, up to 15. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Between the ages of 8-15 years requiring a PIV as part of their management in the emergency department.

You may not qualify if…

• 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.

Where it is running

• Kosair Children's Hospital — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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