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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444756
• Other study ID #: 622.04
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2007
• Last updated: March 7, 2007
• Start date: April 2005
• Est. completion date: April 2006

Study information

• Verified date: March 2007
• Source: Norton Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 15 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• J-tip jet injection of 1% buffered lidocaine

Locations

Country	Name	City	State
United States	Kosair Children's Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Norton Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS pain scores for the PIV insertion as judged by the patients and the blinded observer.
Secondary	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