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

NCT06552351 | Not Yet Recruiting FDA Device

• 1 other identifier: 17204
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (3)

• Pain Score

  The primary outcome measure will be the pain score of infants undergoing lumbar punctures, assessed using a validated pain scale appropriate for infants.

  Immediately post-procedure (within 5 minutes after the lumbar puncture)

• Procedure Success Rate

  The success rate of the lumbar puncture procedure, defined as obtaining an adequate CSF sample on the first attempt without the need for additional anesthesia.

  During the procedure

• Caregiver Satisfaction

  Caregiver satisfaction with the anesthesia method used, measured using a standardized survey or questionnaire completed after the procedure.

  Within 1 hour post-procedure

Study Arms (2)

Needle-Free Jet Injection of 1 % lidocaine

EXPERIMENTAL

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

Device: Needle-Free Jet Injection of 1 % lidocaine

Traditional needle infiltration of 1% lidocaine

EXPERIMENTAL

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

Other: traditional needle infiltration of 1% lidocaine

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.

Also known as: Jet Injection Device, J-tip injection of 1 % lidocaine

Needle-Free Jet Injection of 1 % lidocaine

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.

Traditional needle infiltration of 1% lidocaine

Eligibility Criteria

• Age: 1 Day - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Oklahoma Children's Hospital

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (8)

• 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.

  PMID: 15572969 BACKGROUND

• 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.

  PMID: 29160002 BACKGROUND

• Use of Jet-Injected Lidocaine to Reduce Venipuncture Pain. AAP Grand Rounds, 2016. 35(2): p. 13-13.

  BACKGROUND

• 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.

  PMID: 27055606 BACKGROUND

• 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.

  PMID: 17321005 BACKGROUND

• 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.

  PMID: 20404782 BACKGROUND

• 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.

  PMID: 22743744 BACKGROUND

• 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.

  PMID: 21314772 BACKGROUND

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jamie Laughy, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valorie Owens, MSW

CONTACT

405-271-2429; Valorie-Owens@ouhsc.edu

Olena Kostyuk, MD

CONTACT

646-643-4355; Olena-Kostyuk@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to receive either needle-free jet injection or traditional lidocaine needle infiltration for local anesthesia during infant lumbar puncture

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 14, 2024
• Study Start: November 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)