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

Condition(s) targeted: Pain

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

Phase: Phase 4

Status: Completed

Sponsored by: Norton Healthcare

Official(s) and/or principal investigator(s):
In K Kim, MD, Study Director, Affiliation: Department of Pediatric Emergency Medicine, Department of Pediatrics, Kosair Children’s Hospital, University of Louisville, Louisville, Kentucky

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.

Official title: Jet Injection of 1% Buffered Lidocaine Versus Topical ELA-Max for Anesthesia Prior to Peripheral Intravenous Catheterization in Children

Study design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: VAS pain scores for the PIV insertion as judged by the patients and the blinded observer.

Secondary outcome: 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

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.

Minimum age: 8 Years. Maximum age: 15 Years. Gender(s): Both.

Criteria:

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.

Kosair Children's Hospital, Louisville, Kentucky 40202, United States

Starting date: April 2005
Ending date: April 2006
Last updated: March 7, 2007