Trial Outcomes & Findings for Needle-Free Jet Injection of Lidocaine During Lumbar Puncture (NCT NCT01224431)

Results Overview

Pain scores at time of needle insertion using neonatal facial coding score. The scale has five components; cry, brow bulge, eye squeeze; nasolabial fold and open month. Each component is either present or absent, with a value of 0 or 1 given. Minimum score of 0 and a maximum score of 5 possible

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure.

Results posted on

2018-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Needleless Injection of Buffered Lidocaine needleless injection of buffered lidocaine prior to lumbar puncture	Normal Saline Via Needleless Injection needleless injection of normal saline prior to lumbar puncture
Overall Study STARTED	30	30
Overall Study COMPLETED	30	25
Overall Study NOT COMPLETED	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Needleless Injection of Buffered Lidocaine needleless injection of buffered lidocaine prior to lumbar puncture	Normal Saline Via Needleless Injection needleless injection of normal saline prior to lumbar puncture
Overall Study not randomized	0	4
Overall Study no video record	0	1

Baseline Characteristics

Needle-Free Jet Injection of Lidocaine During Lumbar Puncture

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Needleless Injection of Buffered Lidocaine n=30 Participants needleless injection of buffered lidocaine prior to lumbar puncture	Normal Saline Via Needleless Injection n=30 Participants needleless injection of normal saline prior to lumbar puncture	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	48 days STANDARD_DEVIATION 15 • n=5 Participants	40 days STANDARD_DEVIATION 18 • n=7 Participants	44 days STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure.

Pain scores at time of needle insertion using neonatal facial coding score. The scale has five components; cry, brow bulge, eye squeeze; nasolabial fold and open month. Each component is either present or absent, with a value of 0 or 1 given. Minimum score of 0 and a maximum score of 5 possible

Outcome measures

Outcome measures
Measure	Needleless Injection of Buffered Lidocaine n=30 Participants needleless injection of buffered lidocaine prior to lumbar puncture	Normal Saline Via Needleless Injection n=30 Participants needleless injection of normal saline prior to lumbar puncture
Pain, Measured as Units on a Scale	4.0 units on scale, 0-5 Standard Deviation 1.3	4.8 units on scale, 0-5 Standard Deviation 0.5

SECONDARY outcome

Timeframe: On average the first hour in the emergency department; from needle stick to end of lumbar puncture

cry video recorded and measured after needle stick until pt stopped crying

Outcome measures

Outcome measures
Measure	Needleless Injection of Buffered Lidocaine n=30 Participants needleless injection of buffered lidocaine prior to lumbar puncture	Normal Saline Via Needleless Injection n=25 Participants needleless injection of normal saline prior to lumbar puncture
Length of Cry	38.53 seconds Standard Deviation 18.63	48.76 seconds Standard Deviation 16.15

Adverse Events

Buffered Lidacaine J-tip

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline 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

Angelique Ferayorni

Phoenix Children's Hospital

Phone: 602-546-1910

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place