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

NCT06552351 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-10-10

No results posted yet for this study

Summary

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.

Conditions

  • Anesthesia

Interventions

DEVICE

Needle-Free Jet Injection of 1 % lidocaine

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

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.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Jamie Laughy, MD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2025-08-01
Completion
2025-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06552351 on ClinicalTrials.gov