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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Colorado Clinical & Translational Sciences Institute
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01628874
First received: June 25, 2012
Last updated: March 6, 2013
Last verified: November 2012

June 25, 2012
March 6, 2013
September 2012
September 2014   (final data collection date for primary outcome measure)
  • Pain Score [ Time Frame: Immediately Post-Procedure ] [ Designated as safety issue: No ]
    The pain score will be self-reported on a 10-point Visual Analogue Scale (VAS) for patients 4-18 years of age and assessed using a 5-point Neonatal Coding System (NFCS) for patients 0-4 months of age.
  • Pain Score [ Time Frame: At Needle Insertion ] [ Designated as safety issue: No ]
    The pain score will be self-reported on a 10-point Visual Analogue Scale (VAS) for patients 4-18 years of age and assessed using a 5-point Neonatal Coding System (NFCS) for patients 0-4 months of age.
  • Pain Score [ Time Frame: At time J-TIP is used ] [ Designated as safety issue: No ]
    The pain score will be self-reported on a 10-point Visual Analogue Scale (VAS) for patients 4-18 years of age and assessed using a 5-point Neonatal Coding System (NFCS) for patients 0-4 months of age.
Same as current
Complete list of historical versions of study NCT01628874 on ClinicalTrials.gov Archive Site
  • Lumbar Puncture Success [ Time Frame: Immediately following lumbar puncture ] [ Designated as safety issue: No ]
    The success of lumbar puncture is defined as obtaining Cerebrospinal fluid (CSF) on the first attempt and <1000 Red Blood Cells/millimeter cubed
  • Change in Heart Rate [ Time Frame: Pre-Procedure and during procedure, measured continously ] [ Designated as safety issue: No ]
    Heart rate will be measured prior to the procedure and also continuously throughout the procedure. The greatest difference between the pre-procedure heart rate and the highest heart rate during the procedure will be used.
  • Lumbar Puncture Success [ Time Frame: Immediately following lumbar puncture ] [ Designated as safety issue: No ]
    The success of lumbar puncture is defined as obtaining Cerbrospinal fluid (CSF) on the first attempt and <1000 Red Blood Cells/milimeter cubed
  • Change in Heart Rate [ Time Frame: Pre-Procedure and during procedure, measured continously ] [ Designated as safety issue: No ]
    Heart rate will be measured prior to the procedure and also continuously throught the procedure. The greatest difference between the pre-procedure heart rate and the highest heart rate during the procedure will be used.
Not Provided
Not Provided
 
Jet Injection of 1% Buffered Lidocaine Versus Topical EMLA for Local Anesthesia Before Lumbar Puncture in Children
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Lumbar Puncture
  • Topical Analgesia
  • Device: J-Tip
    Used once for both arms prior to lumbar puncture. The Experimental arm will receive 0.5 mL (5mg) of 1% Lidocaine. The Active Comparator arm will receive normal saline. This will occur after the cream has been placed for 30 minutes and wiped away and prior to the lumbar puncture.
    Other Name: Needle-free jet-injection system
  • Drug: EMLA
    In the Active Comparator arm, lidocaine 2.5% and prilocaine 2.5% cream placed over area where lumbar puncture will occur for at least 30 minutes. This same procedure will occur for the Experimental arm with a placebo cream instead. This will occur once prior to the J-Tip injection and lumbar puncture.
    Other Name: EMLA Cream
  • Drug: Lidocaine
    5 mg given via J-Tip once, repeat dosing as needed in the Experimental group. A placebo will be given in the Active Comparator group.
  • Experimental: Lidocaine Injection
    0.5 mL (5mg) of 1% lidocaine injection given with the J-Tip
    Interventions:
    • Device: J-Tip
    • Drug: EMLA
    • Drug: Lidocaine
  • Active Comparator: lidocaine 2.5% and prilocaine 2.5% (EMLA) Cream
    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.
    Interventions:
    • Device: J-Tip
    • Drug: EMLA
    • Drug: Lidocaine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
387
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
up to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01628874
12-0542
No
University of Colorado, Denver
University of Colorado, Denver
Colorado Clinical & Translational Sciences Institute
Principal Investigator: Ryan Caltagirone, MD Children's Hospital Colorado and University of Colorado Denver
Principal Investigator: Kathleen Adelgais, MD, MPH Children's Hospital Colorado and University of Colorado Denver
University of Colorado, Denver
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP