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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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J-tip jet injection of 1% buffered lidocaine

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes