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



Status:Completed
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:Any - 18
Updated:10/18/2018
Start Date:September 2012
End Date:August 2016

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A Double-Blind, Randomized Controlled Trial of Jet Injection of 1% Buffered Lidocaine Versus Topical EMLA for Local Anesthesia Before Lumbar Puncture in Children

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.

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.

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.
We found this trial at
1
site
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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