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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00444756
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : March 8, 2007
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pain Procedure: J-tip jet injection of 1% buffered lidocaine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Jet Injection of 1% Buffered Lidocaine Versus Topical ELA-Max for Anesthesia Prior to Peripheral Intravenous Catheterization in Children
Study Start Date : April 2005
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00444756

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United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Norton Healthcare
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Study Director: In K Kim, MD Department of Pediatric Emergency Medicine, Department of Pediatrics, Kosair Children's Hospital, University of Louisville, Louisville, Kentucky
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00444756    
Other Study ID Numbers: 622.04
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: March 8, 2007
Last Verified: March 2007
Keywords provided by Norton Healthcare:
local anesthesia
peripheral IV
Local anesthesia prior to peripheral IV insertion
Additional relevant MeSH terms:
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Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action