An interventional study of J-Tip and EMLA in Lumbar Puncture and Topical Analgesia, sponsored by University of Colorado, Denver. Terminated at 1 site in United States. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-21.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 66 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.5 mL (5mg) of 1% lidocaine injection given with the J-Tip
Device: J-Tip · Drug: EMLA · Drug: Lidocaine
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 · Drug: EMLA · Drug: Lidocaine
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.
Also known as: Needle-free jet-injection system
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.
Also known as: EMLA Cream
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.
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
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
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
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
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
| Milestone | EMLA Cream, Then Placebo Via J-Tip | Placebo Cream, Then Lidocaine Via J-Tip |
|---|---|---|
| Started | 34 | 32 |
| Completed | 29 | 29 |
| Not completed | 5 | 3 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Age >4 months | 4 | 2 |
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.
| score on a scale | EMLA Cream, Then Placebo Via J-Tip | Placebo Cream, Then Lidocaine Via J-Tip |
|---|---|---|
| Pain Score | 0 (0 to 0.5) | 0 (0 to 0) |
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.
| score on a scale | EMLA Cream, Then Placebo Via J-Tip | Placebo Cream, Then Lidocaine Via J-Tip |
|---|---|---|
| Pain Score | 5 (5 to 5) | 5 (4 to 5) |
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.
| score on a scale | EMLA Cream, Then Placebo Via J-Tip | Placebo Cream, Then Lidocaine Via J-Tip |
|---|---|---|
| Pain Score | 5 (5 to 5) | 5 (5 to 5) |
The success of lumbar puncture was defined as obtaining Cerebrospinal fluid (CSF) on the first attempt and \<1000 Red Blood Cells/millimeter cubed
| Participants | EMLA Cream, Then Placebo Via J-Tip | Placebo Cream, Then Lidocaine Via J-Tip |
|---|---|---|
| Number of Participants With Lumbar Puncture Success | 8 | 16 |
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
| Beats per Minute | EMLA Cream, Then Placebo Via J-Tip | Placebo Cream, Then Lidocaine Via J-Tip |
|---|---|---|
| Pre-procedure | 154 ± 40 | 156 ± 28 |
| J-Tip application | 160 ± 37 | 167 ± 29 |
| Needle insertion | 170 ± 49 | 169 ± 35 |
| Needle in place | 172 ± 54 | 178 ± 40 |
| Post-procedure | 157 ± 30 | 159 ± 26 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EMLA Cream, Then Placebo Via J-Tip | — | 0/34 (0%) | 0/34 (0%) |
| Placebo Cream, Then Lidocaine Via J-Tip | — | 0/32 (0%) | 0/32 (0%) |
| Age, Continuous(days) | EMLA Cream, Then Placebo Via J-Tip | Placebo Cream, Then Lidocaine Via J-Tip | Total |
|---|---|---|---|
| Median | 30 (19 to 48) | 41 (28 to 50) | 35.5 (20 to 51.5) |
| Sex: Female, Male(Participants) | EMLA Cream, Then Placebo Via J-Tip | Placebo Cream, Then Lidocaine Via J-Tip | Total |
|---|---|---|---|
| Female | 12 | 10 | 22 |
| Male | 17 | 19 | 36 |
| Ethnicity (NIH/OMB)(Participants) | EMLA Cream, Then Placebo Via J-Tip | Placebo Cream, Then Lidocaine Via J-Tip | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 11 | 21 |
| Not Hispanic or Latino | 19 | 18 | 37 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | EMLA Cream, Then Placebo Via J-Tip | Placebo Cream, Then Lidocaine Via J-Tip | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 1 | 7 | 8 |
| White | 20 | 16 | 36 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 4 | 11 |
This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Colorado, Denver