Needle-Free Lidocaine Injection vs Traditional Local Anesthesia in Infant Lumbar Puncture

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT06552351
Status
Not Yet Recruiting

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Conditions

  • Anesthesia

Eligibility Criteria

Sex
ALL
Age
1 Day - 3 Months
Healthy Volunteers
Not accepted

Interventions

  • Needle-Free Jet Injection of 1 % lidocaine — DEVICE
    The needle-free jet injection device delivers 1% lidocaine through high-pressure fluid without the use of a needle. This method aims to reduce the pain associated with needle-based anesthesia during infant lumbar punctures.
  • traditional needle infiltration of 1% lidocaine — OTHER
    Traditional needle infiltration involves injecting 1% lidocaine with a needle to provide local anesthesia before an infant lumbar puncture. This method is the standard practice for pain management in such procedures.

Study Details

We hypothesize that the J-Tip needle-free jet-injection system offers comparable pain control and greater provider satisfaction due to its less invasive nature compared to traditional needle infiltration of 1% lidocaine in infants undergoing lumbar punctures. Our aim is to evaluate the efficacy and feasibility of different local anesthetic techniques in the ED setting by comparing traditional lidocaine needle infiltration with J-tip.

Key Dates

Start date
Nov 30, 2024
Status verified
Oct 2024
Primary completion
Aug 1, 2025
Completion
Aug 1, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Needle-Free Jet Injection of 1 % lidocaine
    Device: Needle-Free Jet Injection The needle-free jet injection device delivers 1 % Lidocaine through high-pressure fluid without the use of a needle. This method aims to reduce the pain associated with needle-based anesthesia during infant lumbar punctures. Other Names: • Jet Injection Device, J-tip
  • Experimental: Traditional needle infiltration of 1% lidocaine
    Traditional needle infiltration involves injecting 1% lidocaine with a needle to provide local anesthesia before an infant lumbar puncture. This method is the standard practice for pain management in such procedures. Other Names: • traditional needle infiltration of 1% lidocaine

Primary Outcome Measure

Pain Score [ Time Frame: Immediately post-procedure (within 5 minutes after the lumbar puncture) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oklahoma Children's HospitalOklahoma CityOklahoma73104
Valorie Owens
[email protected]
405-271-2429
Olena Kostyuk, MD
[email protected]
6466434355

Find similar trials in Oklahoma City, OK

By research site
Oklahoma Children's Hospital· Oklahoma City, OK

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