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Completed

NCT Number: NCT00444756

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

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Key information

Conditions

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

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

J-tip jet injection of 1% buffered lidocaine

Procedure

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

Sponsors and collaborators

Lead sponsor

Norton Healthcare

Other

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Mar 8, 2007
Registry last updated
Mar 8, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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