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

Norton Healthcare

Status and phase

Completed

Phase 4

Conditions

Pain

Treatments

Procedure: J-tip jet injection of 1% buffered lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT00444756

622.04

Details and patient eligibility

About

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.

Full 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 presenting to a tertiary care pediatric emergency department for PIV insertion. All subjects recorded self-reported Visual Analogue Scale (VAS) scores for pain at time of enrollment and pain of PIV insertion. Jet injection subjects also recorded pain of jet injection. Subjects were videotaped during jet injection and PIV insertion. Videotapes were reviewed by a single blinded reviewer for observer-reported VAS pain scores for jet injection and PIV insertion.

Sex

All

Ages

8 to 15 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.