Needle-Free Lidocaine Injection vs Traditional Local Anesthesia in Infant Lumbar Puncture
NCT ID: NCT06552351
Last Updated: 2024-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2024-11-30
2025-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Needle-Free Jet Injection of Lidocaine During Lumbar Puncture
NCT01224431
Jet Injection of 1% Buffered Lidocaine Versus Topical EMLA for Local Anesthesia Before Lumbar Puncture in Children
NCT01628874
The Use of Jet Injection Lidocaine for Blood Draws in Young Children
NCT01890642
Jet Lidocaine for Pain Relief During Needle Insertion in a Pediatric Emergency Department
NCT00681902
Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy
NCT02649322
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* 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
1 Day
3 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Oklahoma
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jamie Laughy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oklahoma Children's Hospital
Oklahoma City, Oklahoma, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Baxter AL, Welch JC, Burke BL, Isaacman DJ. Pain, position, and stylet styles: infant lumbar puncture practices of pediatric emergency attending physicians. Pediatr Emerg Care. 2004 Dec;20(12):816-20. doi: 10.1097/01.pec.0000148030.99339.fe.
Caltagirone R, Raghavan VR, Adelgais K, Roosevelt GE. A Randomized Double Blind Trial of Needle-free Injected Lidocaine Versus Topical Anesthesia for Infant Lumbar Puncture. Acad Emerg Med. 2018 Mar;25(3):310-316. doi: 10.1111/acem.13351. Epub 2017 Dec 26.
Use of Jet-Injected Lidocaine to Reduce Venipuncture Pain. AAP Grand Rounds, 2016. 35(2): p. 13-13.
Hajimaghsoudi M, Vahidi E, Momeni M, Arabinejhad A, Saeedi M. Comparison of local anesthetic effect of lidocaine by jet injection vs needle infiltration in lumbar puncture. Am J Emerg Med. 2016 Jul;34(7):1225-9. doi: 10.1016/j.ajem.2016.03.030. Epub 2016 Mar 16.
Nigrovic LE, Kuppermann N, Neuman MI. Risk factors for traumatic or unsuccessful lumbar punctures in children. Ann Emerg Med. 2007 Jun;49(6):762-71. doi: 10.1016/j.annemergmed.2006.10.018. Epub 2007 Feb 23.
Fein D, Avner JR, Khine H. Pattern of pain management during lumbar puncture in children. Pediatr Emerg Care. 2010 May;26(5):357-60. doi: 10.1097/PEC.0b013e3181db2026.
Ferayorni A, Yniguez R, Bryson M, Bulloch B. Needle-free jet injection of lidocaine for local anesthesia during lumbar puncture: a randomized controlled trial. Pediatr Emerg Care. 2012 Jul;28(7):687-90. doi: 10.1097/PEC.0b013e31825d210b.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17204
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.