Lumbar Puncture, Topical Analgesia
Conditions
Keywords
Lumbar Puncture, J-Tip, Jet injection, Local Analgesia
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.
Interventions
DEVICEJ-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.
DRUGEMLA
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.
DRUGLidocaine
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.
Sponsors
Colorado Clinical & Translational Sciences Institute
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | Immediately Post-Procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Pre-assignment details
Due to low enrollment, the study was halted prior to getting to the planned protocol enrollment. The patients who were enrolled were used in the analysis per the participant flow module.
Participants by arm
| Arm | Count |
|---|---|
| EMLA Cream, Then Placebo Via J-Tip Patients in this arm received 1g EMLA cream (lidocaine 2.5% and prilocaine 2.5%) placed on the lumbar puncture site for a minimum of 30 minutes. The cream was then wiped away, and they were given 0.5 mL NS placebo injection via the J-Tip at the lumbar puncture site. | 29 |
| Placebo Cream, Then Lidocaine Via J-Tip Participants in this arm had placebo cream placed on the lumbar puncture site for minimum of 30 minutes. The cream was then wiped away, and they were given 0.5 mL (5mg) of 1% lidocaine injection via the J-Tip at the lumbar puncture site. | 29 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Age >4 months | 4 | 2 |
| Overall Study | Physician Decision | 1 | 1 |
Baseline characteristics
| Characteristic | Total | EMLA Cream, Then Placebo Via J-Tip | Placebo Cream, Then Lidocaine Via J-Tip |
|---|---|---|---|
| Age, Continuous | 35.5 days | 30 days | 41 days |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 10 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 19 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) White | 36 Participants | 20 Participants | 16 Participants |
| Sex: Female, Male Female | 22 Participants | 12 Participants | 10 Participants |
| Sex: Female, Male Male | 36 Participants | 17 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 32 |
| serious Total, serious adverse events | 0 / 34 | 0 / 32 |
Outcome results
Primary
Pain Score
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.
Time frame: Immediately Post-Procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EMLA Cream, Then Placebo Via J-Tip | Pain Score | 0 score on a scale |
| Placebo Cream, Then Lidocaine Via J-Tip | Pain Score | 0 score on a scale |
Primary
Pain Score
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.
Time frame: At Needle Insertion
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EMLA Cream, Then Placebo Via J-Tip | Pain Score | 5 score on a scale |
| Placebo Cream, Then Lidocaine Via J-Tip | Pain Score | 5 score on a scale |
Primary
Pain Score
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.
Time frame: At time J-TIP is used
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EMLA Cream, Then Placebo Via J-Tip | Pain Score | 5 score on a scale |
| Placebo Cream, Then Lidocaine Via J-Tip | Pain Score | 5 score on a scale |
Secondary
Change in Heart Rate
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
Time frame: At 5 specific points during the procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EMLA Cream, Then Placebo Via J-Tip | Change in Heart Rate | J-Tip application | 160 Beats per Minute | Standard Deviation 37 |
| EMLA Cream, Then Placebo Via J-Tip | Change in Heart Rate | Needle in place | 172 Beats per Minute | Standard Deviation 54 |
| EMLA Cream, Then Placebo Via J-Tip | Change in Heart Rate | Needle insertion | 170 Beats per Minute | Standard Deviation 49 |
| EMLA Cream, Then Placebo Via J-Tip | Change in Heart Rate | Post-procedure | 157 Beats per Minute | Standard Deviation 30 |
| EMLA Cream, Then Placebo Via J-Tip | Change in Heart Rate | Pre-procedure | 154 Beats per Minute | Standard Deviation 40 |
| Placebo Cream, Then Lidocaine Via J-Tip | Change in Heart Rate | Post-procedure | 159 Beats per Minute | Standard Deviation 26 |
| Placebo Cream, Then Lidocaine Via J-Tip | Change in Heart Rate | Pre-procedure | 156 Beats per Minute | Standard Deviation 28 |
| Placebo Cream, Then Lidocaine Via J-Tip | Change in Heart Rate | J-Tip application | 167 Beats per Minute | Standard Deviation 29 |
| Placebo Cream, Then Lidocaine Via J-Tip | Change in Heart Rate | Needle insertion | 169 Beats per Minute | Standard Deviation 35 |
| Placebo Cream, Then Lidocaine Via J-Tip | Change in Heart Rate | Needle in place | 178 Beats per Minute | Standard Deviation 40 |
Secondary
Number of Participants With Lumbar Puncture Success
The success of lumbar puncture was defined as obtaining Cerebrospinal fluid (CSF) on the first attempt and \<1000 Red Blood Cells/millimeter cubed
Time frame: Immediately following lumbar puncture
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EMLA Cream, Then Placebo Via J-Tip | Number of Participants With Lumbar Puncture Success | 8 Participants |
| Placebo Cream, Then Lidocaine Via J-Tip | Number of Participants With Lumbar Puncture Success | 16 Participants |