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
  Purpose

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.


Condition Intervention
Lumbar Puncture
Topical Analgesia
Device: J-Tip
Drug: EMLA
Drug: Lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 387
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine Injection
0.5 mL (5mg) of 1% lidocaine injection given with the J-Tip
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.
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.
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.

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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628874

Locations
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Colorado Clinical & Translational Sciences Institute
Investigators
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
  More Information

Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01628874     History of Changes
Other Study ID Numbers: 12-0542
Study First Received: June 25, 2012
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Lumbar Puncture
J-Tip
Jet injection
Local Analgesia

Additional relevant MeSH terms:
EMLA
Lidocaine
Anesthetics
Anesthetics, Combined
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 23, 2014