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

March 7, 2007
March 7, 2007
April 2005
Not Provided
VAS pain scores for the PIV insertion as judged by the patients and the blinded observer.
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Jet Injection of 1% Buffered Lidocaine Versus Topical ELA-Max for Anesthesia Prior to Intravenous (IV) Catheterization in Children
Jet Injection of 1% Buffered Lidocaine Versus Topical ELA-Max for Anesthesia Prior to Peripheral Intravenous Catheterization in Children

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Pain
Procedure: J-tip jet injection of 1% buffered lidocaine
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
April 2006
Not Provided

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.
Both
8 Years to 15 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00444756
622.04
Yes
Not Provided
Norton Healthcare
Not Provided
Study Director: In K Kim, MD Department of Pediatric Emergency Medicine, Department of Pediatrics, Kosair Children’s Hospital, University of Louisville, Louisville, Kentucky
Norton Healthcare
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP