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

Phase 4

Completed

• Conditions: Pain

• Registration Number: NCT00444756
• Lead Sponsor: Norton Healthcare

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

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 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.

Study Timeline

• Study Start: 2005-04
• Study Completion: 2006-04
• Status Verified: 2007-03
• Study First Submitted: 2007-03-07
• Study First Submitted QC: 2007-03-07
• Last Update Submitted: 2007-03-07
• Study First Posted: 2007-03-08
• Last Update Posted: 2007-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
VAS pain scores for the PIV insertion as judged by the patients and the blinded observer.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures included patient and blinded observer VAS scores for pain of jet injection, patient and blinded observer scores for anxiety of PIV insertion, nursing satisfaction of placing the PIV with jet injection or ELA-Maxâ, nursing diffi

Trial Locations

Locations (1)

Kosair Children's Hospital; 🇺🇸 Louisville, Kentucky, United States