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

Study Overview
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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.

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.

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

Conditions
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Pain

Intervention / Treatment
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* Procedure: J-tip jet injection of 1% buffered lidocaine


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: J-tip jet injection of 1% buffered lidocaine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain scores for the PIV insertion as judged by the patients and the blinded observer. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local anesthesia, analgesia, peripheral IV, Local anesthesia prior to peripheral IV insertion