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

NCT00444756 | Completed Phase 4 DMC

• 1 other identifier: 622.04
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Interventions

J-tip jet injection of 1% buffered lidocaine PROCEDURE

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Between the ages of 8-15 years requiring a PIV as part of their management in the emergency department.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norton Healthcare: lead

Study Sites (1)

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• 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. doi: 10.1097/PEC.0b013e31816a8d5b.

  PMID: 18645542 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• In K Kim, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 8, 2007
• Study Start: April 1, 2005
• Study Completion: April 1, 2006
• Last Updated: March 8, 2007

Record last verified: 2007-03

Locations

US (1)