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

This study has been completed.
Sponsor:
Information provided by:
Norton Healthcare
ClinicalTrials.gov Identifier:
NCT00444756
First received: March 7, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
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:

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 ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Norton Healthcare:
local anesthesia
analgesia
peripheral IV
Local anesthesia prior to peripheral IV insertion

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013