Jet Injection of 1% Buffered Lidocaine Versus Topical EMLA for Local Anesthesia Before Lumbar Puncture in Children

Not Applicable

Terminated

Conditions: Lumbar Puncture
Topical Analgesia

Interventions: Device: J-Tip
Drug: EMLA
Drug: Lidocaine

Registration Number: NCT01628874

Lead Sponsor: University of Colorado, Denver

Brief Summary: The purpose of this study is to evaluate the effectiveness of a needle-free jet-injection system with 1% buffered lidocaine for local anesthesia for lumbar punctures compared to a topical anesthetic agent. Our hypothesis is: A needle-free jet-injection system (J-Tip) with 1% lidocaine will provide local anesthesia that is comparable to that of a topical anesthetic agent (EMLA cream) when performing lumbar punctures in children.

Detailed Description: Lumbar punctures are a common procedure performed in children in the emergency department. In febrile infants they are frequently performed as part of a sepsis evaluation, and in older children they are used in the evaluation of possible meningitis, new seizures, altered mental status and other neurologic emergencies.

Several studies in the pediatric emergency medicine literature have found a positive association between lumbar puncture success and the use of local anesthesia in infant lumbar punctures. Despite this data, studies have shown that 70-76% of lumbar punctures in the emergency department are performed without any form of pain management, with up to 95% of infants receiving no form of pain management. Common reasoning for providers to forgo pain management include the time for topical anesthetics to be effective (30-45 minutes), the pain already associated with injectable lidocaine, and obscuring of anatomic landmarks with injectable lidocaine.

A recent development in pain management for pediatric procedures is the use of needle-free jet injection of lidocaine. One such device is the J-Tip, which uses a compressed carbon dioxide (CO2) cartridge to deliver medication to the subcutaneous tissues to a depth of 5-8 mm in 0.2 seconds. It has been shown to be largely pain-free for children. Multiple studies have shown it to be effective in reducing pain associated with peripheral IV placement in children. The J-Tip has recently been approved for peripheral IV starts in the Children's Hospital Colorado emergency department.

Some hospitals anecdotally report using the device for lumbar punctures, but to date no randomized studies have evaluated its effectiveness in pain management compared to other methods. Our study aims to evaluate the efficacy of the J-Tip in lumbar punctures. It offers the advantage of providing much faster anesthesia compared to topical creams, yet does not require the initial skin puncture of injectable lidocaine. If a rapid form of local anesthesia is available, it may increase the overall use of local anesthesia and improve pain management in the pediatric population.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 66

Inclusion Criteria

age ≤4 months or 4-18 years
ability to report VAS for patients 4-18 years
require lumbar puncture as part of their clinical care

Exclusion Criteria

ages 5-47 months
developmental delay or inability to complete VAS in older patients
allergy to lidocaine
requirement of sedation for procedure
pre-procedural analgesia treatment except for nonsteroidal anti-inflammatory drugs and acetaminophen.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine Injection	J-Tip	0.5 mL (5mg) of 1% lidocaine injection given with the J-Tip
lidocaine 2.5% and prilocaine 2.5% (EMLA) Cream	J-Tip	Patients in this arm will receive 1g EMLA cream if they are in the younger age group and 10g EMLA cream if they are in the older age group. This will be placed for a minimum of 30 minutes.
Lidocaine Injection	EMLA	0.5 mL (5mg) of 1% lidocaine injection given with the J-Tip
Lidocaine Injection	Lidocaine	0.5 mL (5mg) of 1% lidocaine injection given with the J-Tip
lidocaine 2.5% and prilocaine 2.5% (EMLA) Cream	EMLA	Patients in this arm will receive 1g EMLA cream if they are in the younger age group and 10g EMLA cream if they are in the older age group. This will be placed for a minimum of 30 minutes.
lidocaine 2.5% and prilocaine 2.5% (EMLA) Cream	Lidocaine	Patients in this arm will receive 1g EMLA cream if they are in the younger age group and 10g EMLA cream if they are in the older age group. This will be placed for a minimum of 30 minutes.

Primary Outcome Measures

Name	Time	Method
Pain Score	At time J-TIP is used	The pain score was assessed using the 5-point Neonatal Coding System (NFCS) on a scale of 0-5, with 0 indicating no pain and 5 the highest level of pain.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Lumbar Puncture Success	Immediately following lumbar puncture	The success of lumbar puncture was defined as obtaining Cerebrospinal fluid (CSF) on the first attempt and \<1000 Red Blood Cells/millimeter cubed
Change in Heart Rate	At 5 specific points during the procedure	Heart rate was measured at 5 points in time (pre-procedure, application of J-Tip, at LP needle insertion, while the needle is in place, and post-procedure) and was compared for significant differences