Clinical trial NCT06552351: Needle-Free Lidocaine Injection vs Traditional Local Anesthesia in Infant Lumbar Puncture
Official title: Needle-Free Jet Injection Versus Traditional Lidocaine Needle Infiltration for Local Anesthesia in Infant Lumbar Puncture
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to receive either needle-free jet injection or traditional lidocaine needle infiltration for local anesthesia during infant lumbar puncture
Primary purpose: TREATMENT

Brief 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.

Detailed description: Lumbar punctures (LPs) play a key role in diagnosing meningitis in febrile infants. The use of local anesthesia is critical to the success of these procedures. Traditional anesthesia techniques, including needle injections and the application of topical anesthetic creams, have been effective in managing pain and enhancing the outcomes of LPs. Recently, the introduction of needle-free jet injection technology, such as the J-Tip system, offers a quicker and less invasive method for delivering local anesthesia.

This research compares the effectiveness of the J-Tip with that of traditional 1% lidocaine infiltration for local anesthesia during LPs in infants.

The investigators 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.

The aim is to evaluate the efficacy and feasibility of different local anesthetic techniques in the ED setting by comparing traditional 1% lidocaine needle infiltration with administration of 1% lidocaine the J-Tip.

Secondary outcomes include the number of attempts to successfully perform the LP, perceptions of pain management effectiveness by ED providers, the need for additional lidocaine, skin condition at the LP site, and the overall success rate of the LP procedures.

EXPERIMENTAL DESIGN:

A single-center, randomized, controlled trial will compare the efficacy of J-Tip-injected lidocaine with conventional needle-injected lidocaine in providing anesthesia for infants undergoing lumbar punctures.

PROPOSED PROCEDURE:

Infants aged 0 to 3 months presenting to the Oklahoma Children's Hospital Emergency Department between July 1, 2024, through June 30, 2025, who require an LP as part of their ED evaluation will be recruited.

Randomization Strategy:

Participants who consent will be randomly divided into two groups: one receiving local anesthesia via the J-Tip syringe containing 1% lidocaine (experimental group) and the other through needle infiltration with the same concentration of lidocaine (control group). Randomization assignments will be provided in sealed envelopes and kept with the study team to be included in a study packet along with the consent forms to be reviewed at the time of enrollment.

The ED provider performing the LP will independently evaluate pain levels using the Neonatal Infant Pain Scale (NIPS) immediately before the LP begins and at the time of needle insertion.

A brief period of up to 5 minutes will follow the topical anesthesia application to allow infants to calm and reach a steady state, accounting for any initial discomfort or startle response.

After the LP, attending providers will complete a questionnaire detailing the number of attempts, any encountered difficulties, additional lidocaine usage, their assessment of pain control during the procedure, any skin changes at the LP site, and LP success, defined as obtaining cerebrospinal fluid.

Outcome Measures:

Primary Outcome: Pain levels, as measured by NIPS scores, immediately before the LP and at needle insertion.

The NIPS (Neonatal Infant Pain Scale) is a scoring system used to assess pain in newborns and infants up to 1 year of age. It is a behavioral scale that evaluates specific criteria to determine the level of pain the infant may be experiencing.

NIPS Scoring System:

Facial Expression (0-1 points) 0: Relaxed facial expression

1: Grimace Cry (0-2 points) 0: No cry

1. Whimper
2. Vigorous cry Breathing Patterns (0-1 points)

0: Relaxed breathing

1: Change in breathing patterns (e.g., irregular, fast, or slow breathing) Arm Movements (0-1 points) 0: Relaxed, no movement or only gentle movements

1: Flexed or extended movements (restless, jerking) Leg Movements (0-1 points) 0: Relaxed, no movement or only gentle movements

1: Flexed or extended movements (restless, jerking) State of Arousal (0-1 points) 0: Sleeping or calm

1: Fussy

Scoring Interpretation:

0-2 points: Mild or no pain 3-4 points: Moderate pain 5-7 points: Severe pain

Secondary Outcomes: Include the number of LP attempts, any difficulties encountered (open-ended), provider's perception of pain control (1-5 scale), additional lidocaine use, post-procedure skin reactions (classified as minor/moderate or severe induration, bleeding), and LP success. Additionally, it will be determined if the LP was traumatic by reviewing patient charts, defined as having a cerebrospinal fluid (CSF) red blood cell (RBC) count of ≥ 1000 cells/mm³.

Provider Information: Details about the providers performing the LP, including their level of training (APP, fellow, attending, resident) and prior experience with LPs (categorized as 0-5, 6-10, 11-20, \>20 attempts), will be documented.

Data will be entered into REDCap and only authorized key study personnel will have access. Identifiers will be removed, and the de-identified information may be used for future research without additional informed consent from the participant.

Eligibility criteria: Infants requiring lumbar puncture for diagnostic or therapeutic purposes

* Age 0 to 3 months
* Parental/guardian consent obtained

Exclusion Criteria:

* Infants with known allergy or hypersensitivity to lidocaine or components of the needle-free jet injection device
* Infants with significant skin infection or dermatitis at the site of injection
* Infants with coagulopathy or any bleeding disorder
* Infants with any other condition that, in the opinion of the investigator, would make participation in the study unsafe or not in the best interest of the infant

Primary outcomes:
measure: Pain Score
timeFrame: Immediately post-procedure (within 5 minutes after the lumbar puncture)
measure: Procedure Success Rate
timeFrame: During the procedure
measure: Caregiver Satisfaction
timeFrame: Within 1 hour post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Children's Hospital
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Jamie Laughy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hoyle JD Jr, Rogers AJ, Reischman DE, Powell EC, Borgialli DA, Mahajan PV, Trytko JA, Stanley RM. Pain intervention for infant lumbar puncture in the emergency department: physician practice and beliefs. Acad Emerg Med. 2011 Feb;18(2):140-4. doi: 10.1111/j.1553-2712.2010.00970.x.