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

Sponsored by:	Norton Healthcare
Information provided by:	Norton Healthcare
ClinicalTrials.gov Identifier:	NCT00444756

Purpose

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	Intervention	Phase
Pain	Procedure: J-tip jet injection of 1% buffered lidocaine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Jet Injection of 1% Buffered Lidocaine Versus Topical ELA-Max for Anesthesia Prior to Peripheral Intravenous Catheterization in Children

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

Drug Information available for: Lidocaine

U.S. FDA Resources

Further study details as provided by Norton Healthcare:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	70
Study Start Date:	April 2005
Estimated Study Completion Date:	April 2006

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.

Eligibility

Ages Eligible for Study:	8 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444756

Locations

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

Sponsors and Collaborators

Norton Healthcare

Investigators

Study Director:

In K Kim, MD

Department of Pediatric Emergency Medicine, Department of Pediatrics, Kosair Children’s Hospital, University of Louisville, Louisville, Kentucky

More Information

No publications provided by Norton Healthcare

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Spanos S, Booth R, Koenig H, Sikes K, Gracely E, Kim IK. Jet Injection of 1% buffered lidocaine versus topical ELA-Max for anesthesia before peripheral intravenous catheterization in children: a randomized controlled trial. Pediatr Emerg Care. 2008 Aug;24(8):511-5.

Study ID Numbers:	622.04
Study First Received:	March 7, 2007
Last Updated:	March 7, 2007
ClinicalTrials.gov Identifier:	NCT00444756 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Norton Healthcare:

local anesthesia
analgesia
peripheral IV
Local anesthesia prior to peripheral IV insertion

Study placed in the following topic categories:

Lidocaine
Central Nervous System Depressants
Anesthetics
Pain

Cardiovascular Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Anesthetics, Local

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Lidocaine
Central Nervous System Depressants
Anesthetics

Cardiovascular Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anesthetics, Local
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009