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

Norton Healthcare70 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pain

Interventions

J-tip jet injection of 1% buffered lidocainePROCEDURE

Eligibility

Sex: ALLMin age: 8 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Kosair Children's Hospital

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.