Clinical trial NCT01628874: Jet Injection of 1% Buffered Lidocaine Versus Topical EMLA for Local Anesthesia Before Lumbar Puncture in Children
Official title: A Double-Blind, Randomized Controlled Trial of Jet Injection of 1% Buffered Lidocaine Versus Topical EMLA for Local Anesthesia Before Lumbar Puncture in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lumbar Puncture
Topical Analgesia
Keywords: Lumbar Puncture
J-Tip
Jet injection
Local Analgesia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado Clinical & Translational Sciences Institute
First posted: 2012-06-27
Enrollment: 66
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Score
timeFrame: Immediately Post-Procedure
measure: Pain Score
timeFrame: At Needle Insertion
measure: Pain Score
timeFrame: At time J-TIP is used
Secondary outcomes:
measure: Number of Participants With Lumbar Puncture Success
timeFrame: Immediately following lumbar puncture
measure: Change in Heart Rate
timeFrame: At 5 specific points during the procedure
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado and University of Colorado Denver
name: Ryan Caltagirone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Colorado and University of Colorado Denver
name: Kathleen Adelgais, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.