Trial Outcomes & Findings for Jet Injection of 1% Buffered Lidocaine Versus Topical EMLA for Local Anesthesia Before Lumbar Puncture in Children (NCT NCT01628874)
NCT ID: NCT01628874
Last Updated: 2019-06-21
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Immediately Post-Procedure
Results posted on
2019-06-21
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Age >4 months
|
4
|
2
|
Baseline Characteristics
Jet Injection of 1% Buffered Lidocaine Versus Topical EMLA for Local Anesthesia Before Lumbar Puncture in Children
Baseline characteristics by cohort
| Measure |
EMLA Cream, Then Placebo Via J-Tip
n=29 Participants
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.
|
Placebo Cream, Then Lidocaine Via J-Tip
n=29 Participants
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.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 days
n=5 Participants
|
41 days
n=7 Participants
|
35.5 days
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately Post-ProcedureThe 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.
Outcome measures
| Measure |
EMLA Cream, Then Placebo Via J-Tip
n=29 Participants
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.
|
Placebo Cream, Then Lidocaine Via J-Tip
n=29 Participants
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.
|
|---|---|---|
|
Pain Score
|
0 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: At Needle InsertionThe 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.
Outcome measures
| Measure |
EMLA Cream, Then Placebo Via J-Tip
n=29 Participants
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.
|
Placebo Cream, Then Lidocaine Via J-Tip
n=29 Participants
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.
|
|---|---|---|
|
Pain Score
|
5 score on a scale
Interval 5.0 to 5.0
|
5 score on a scale
Interval 4.0 to 5.0
|
PRIMARY outcome
Timeframe: At time J-TIP is usedThe 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.
Outcome measures
| Measure |
EMLA Cream, Then Placebo Via J-Tip
n=29 Participants
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.
|
Placebo Cream, Then Lidocaine Via J-Tip
n=29 Participants
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.
|
|---|---|---|
|
Pain Score
|
5 score on a scale
Interval 5.0 to 5.0
|
5 score on a scale
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: Immediately following lumbar punctureThe success of lumbar puncture was defined as obtaining Cerebrospinal fluid (CSF) on the first attempt and \<1000 Red Blood Cells/millimeter cubed
Outcome measures
| Measure |
EMLA Cream, Then Placebo Via J-Tip
n=29 Participants
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.
|
Placebo Cream, Then Lidocaine Via J-Tip
n=29 Participants
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.
|
|---|---|---|
|
Number of Participants With Lumbar Puncture Success
|
8 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: At 5 specific points during the procedureHeart 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
Outcome measures
| Measure |
EMLA Cream, Then Placebo Via J-Tip
n=29 Participants
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.
|
Placebo Cream, Then Lidocaine Via J-Tip
n=29 Participants
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.
|
|---|---|---|
|
Change in Heart Rate
Post-procedure
|
157 Beats per Minute
Standard Deviation 30
|
159 Beats per Minute
Standard Deviation 26
|
|
Change in Heart Rate
Pre-procedure
|
154 Beats per Minute
Standard Deviation 40
|
156 Beats per Minute
Standard Deviation 28
|
|
Change in Heart Rate
J-Tip application
|
160 Beats per Minute
Standard Deviation 37
|
167 Beats per Minute
Standard Deviation 29
|
|
Change in Heart Rate
Needle insertion
|
170 Beats per Minute
Standard Deviation 49
|
169 Beats per Minute
Standard Deviation 35
|
|
Change in Heart Rate
Needle in place
|
172 Beats per Minute
Standard Deviation 54
|
178 Beats per Minute
Standard Deviation 40
|
Adverse Events
EMLA Cream, Then Placebo Via J-Tip
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Cream, Then Lidocaine Via J-Tip
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place