Trial Outcomes & Findings for The Use of Jet Injection Lidocaine for Blood Draws in Young Children (NCT NCT01890642)

Last Updated: 2015-10-06

Results Overview

Pain score assessed by video reviewer at J-tip, J-tip noise or researcher approach (1 minute) and at venipuncture (3 minutes). The score at J-tip noise/researcher approach was subtracted from the score at venipuncture to give a number indicating the change in pain scores. The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.

Recruitment status

COMPLETED

Study phase

Target enrollment

205 participants

Primary outcome timeframe

3 min

Results posted on

2015-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	J Tip Noise This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine Pain Ease Spray: Cold Spray used to anesthetize the skin	Pain Ease This group will receive Pain Ease Spray Pain Ease Spray: Cold Spray used to anesthetize the skin	J Tip This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine 1% buffered lidocaine: Lidocaine placed using Jet Injection placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray
Overall Study STARTED	56	53	96
Overall Study COMPLETED	56	53	96
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of Jet Injection Lidocaine for Blood Draws in Young Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	J Tip Noise n=56 Participants This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine Pain Ease Spray: Cold Spray used to anesthetize the skin	Pain Ease n=53 Participants This group will receive Pain Ease Spray Pain Ease Spray: Cold Spray used to anesthetize the skin	J Tip n=96 Participants This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine 1% buffered lidocaine: Lidocaine placed using Jet Injection placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray	Total n=205 Participants Total of all reporting groups
Age, Categorical <=18 years	56 Participants n=93 Participants	53 Participants n=4 Participants	96 Participants n=27 Participants	205 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Continuous	3.4 years STANDARD_DEVIATION 1.6 • n=93 Participants	2.9 years STANDARD_DEVIATION 1.7 • n=4 Participants	3.3 years STANDARD_DEVIATION 1.9 • n=27 Participants	3.2 years STANDARD_DEVIATION 1.7 • n=483 Participants
Sex: Female, Male Female	25 Participants n=93 Participants	16 Participants n=4 Participants	42 Participants n=27 Participants	83 Participants n=483 Participants
Sex: Female, Male Male	31 Participants n=93 Participants	37 Participants n=4 Participants	54 Participants n=27 Participants	122 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	8 Participants n=93 Participants	9 Participants n=4 Participants	21 Participants n=27 Participants	38 Participants n=483 Participants
Race (NIH/OMB) White	34 Participants n=93 Participants	31 Participants n=4 Participants	45 Participants n=27 Participants	110 Participants n=483 Participants
Race (NIH/OMB) More than one race	6 Participants n=93 Participants	3 Participants n=4 Participants	16 Participants n=27 Participants	25 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=93 Participants	9 Participants n=4 Participants	12 Participants n=27 Participants	29 Participants n=483 Participants
Region of Enrollment United States	56 participants n=93 Participants	53 participants n=4 Participants	96 participants n=27 Participants	205 participants n=483 Participants
Previous Venipuncture	55 participants n=93 Participants	51 participants n=4 Participants	96 participants n=27 Participants	202 participants n=483 Participants

PRIMARY outcome

Timeframe: 3 min

Outcome measures

Outcome measures
Measure	J Tip Noise n=56 Participants This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine Pain Ease Spray: Cold Spray used to anesthetize the skin	Pain Ease n=53 Participants This group will receive Pain Ease Spray Pain Ease Spray: Cold Spray used to anesthetize the skin	J Tip n=96 Participants This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine 1% buffered lidocaine: Lidocaine placed using Jet Injection placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray
Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture	1.71 units on a scale Standard Error 0.42	2.82 units on a scale Standard Error 0.45	0.23 units on a scale Standard Error 0.28

SECONDARY outcome

Timeframe: At venipuncture (3 minutes)

Pain score as assessed by video reviewers. The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.

Outcome measures

Outcome measures
Measure	J Tip Noise n=56 Participants This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine Pain Ease Spray: Cold Spray used to anesthetize the skin	Pain Ease n=53 Participants This group will receive Pain Ease Spray Pain Ease Spray: Cold Spray used to anesthetize the skin	J Tip n=96 Participants This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine 1% buffered lidocaine: Lidocaine placed using Jet Injection placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray
Pain Score	5.75 units on a scale Interval 2.75 to 9.0	8 units on a scale Interval 3.5 to 10.0	5.25 units on a scale Interval 1.5 to 8.25

SECONDARY outcome

Timeframe: up to 3 minutes

Proportion of patients where blood draw was successful on first attempt

Outcome measures

Outcome measures
Measure	J Tip Noise n=56 Participants This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine Pain Ease Spray: Cold Spray used to anesthetize the skin	Pain Ease n=53 Participants This group will receive Pain Ease Spray Pain Ease Spray: Cold Spray used to anesthetize the skin	J Tip n=96 Participants This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine 1% buffered lidocaine: Lidocaine placed using Jet Injection placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray
Fist Attempt Success	52 participants	48 participants	86 participants

SECONDARY outcome

Timeframe: 3 min

Pain score assessed by video reviewer before intervention (0 minute) and at venipuncture (3 minutes). The score at baseline was subtracted from the score at venipuncture to give a number indicating the change in pain scores. The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.

Outcome measures

Outcome measures
Measure	J Tip Noise n=56 Participants This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine Pain Ease Spray: Cold Spray used to anesthetize the skin	Pain Ease n=53 Participants This group will receive Pain Ease Spray Pain Ease Spray: Cold Spray used to anesthetize the skin	J Tip n=96 Participants This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine 1% buffered lidocaine: Lidocaine placed using Jet Injection placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray
Change in Pain Score From Baseline	2.32 units on a scale Standard Error 0.48	3.7 units on a scale Standard Error 0.49	1.58 units on a scale Standard Error 0.31

SECONDARY outcome

Timeframe: 1 minute

Pain when J-tip deployed assessed by video reviewers using pain scale. The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.

Outcome measures

Outcome measures
Measure	J Tip Noise n=56 Participants This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine Pain Ease Spray: Cold Spray used to anesthetize the skin	Pain Ease n=53 Participants This group will receive Pain Ease Spray Pain Ease Spray: Cold Spray used to anesthetize the skin	J Tip n=96 Participants This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine 1% buffered lidocaine: Lidocaine placed using Jet Injection placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray
Pain at J-tip Deployment	3.25 units on a scale Interval 0.5 to 7.25	2.5 units on a scale Interval 0.5 to 6.5	4.0 units on a scale Interval 0.5 to 8.5

Adverse Events

J Tip Noise

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Pain Ease

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

J Tip

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	J Tip Noise n=46 participants at risk；n=56 participants at risk This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine Pain Ease Spray: Cold Spray used to anesthetize the skin	Pain Ease n=46 participants at risk；n=53 participants at risk This group will receive Pain Ease Spray Pain Ease Spray: Cold Spray used to anesthetize the skin	J Tip n=83 participants at risk；n=96 participants at risk This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine 1% buffered lidocaine: Lidocaine placed using Jet Injection placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray
Skin and subcutaneous tissue disorders Bruise present at 24 hours	6.5% 3/46 • Number of events 3 • Patients were assessed for serious events immediately following venipuncture and then the next day via phone follow up. All patients were assessed for serious adverse events in the lab. Attempts were made to contact the families of all patients the next day for follow up. The research team was unable to contact some families for follow up, therefore the number of patients assessed for Other Adverse Events is smaller than those assessed for Serious Adverse Events.	6.5% 3/46 • Number of events 3 • Patients were assessed for serious events immediately following venipuncture and then the next day via phone follow up. All patients were assessed for serious adverse events in the lab. Attempts were made to contact the families of all patients the next day for follow up. The research team was unable to contact some families for follow up, therefore the number of patients assessed for Other Adverse Events is smaller than those assessed for Serious Adverse Events.	14.5% 12/83 • Number of events 12 • Patients were assessed for serious events immediately following venipuncture and then the next day via phone follow up. All patients were assessed for serious adverse events in the lab. Attempts were made to contact the families of all patients the next day for follow up. The research team was unable to contact some families for follow up, therefore the number of patients assessed for Other Adverse Events is smaller than those assessed for Serious Adverse Events.
Skin and subcutaneous tissue disorders Redness	4.3% 2/46 • Number of events 2 • Patients were assessed for serious events immediately following venipuncture and then the next day via phone follow up. All patients were assessed for serious adverse events in the lab. Attempts were made to contact the families of all patients the next day for follow up. The research team was unable to contact some families for follow up, therefore the number of patients assessed for Other Adverse Events is smaller than those assessed for Serious Adverse Events.	0.00% 0/46 • Patients were assessed for serious events immediately following venipuncture and then the next day via phone follow up. All patients were assessed for serious adverse events in the lab. Attempts were made to contact the families of all patients the next day for follow up. The research team was unable to contact some families for follow up, therefore the number of patients assessed for Other Adverse Events is smaller than those assessed for Serious Adverse Events.	0.00% 0/83 • Patients were assessed for serious events immediately following venipuncture and then the next day via phone follow up. All patients were assessed for serious adverse events in the lab. Attempts were made to contact the families of all patients the next day for follow up. The research team was unable to contact some families for follow up, therefore the number of patients assessed for Other Adverse Events is smaller than those assessed for Serious Adverse Events.
Injury, poisoning and procedural complications Other/Not Specified	2.2% 1/46 • Number of events 1 • Patients were assessed for serious events immediately following venipuncture and then the next day via phone follow up. All patients were assessed for serious adverse events in the lab. Attempts were made to contact the families of all patients the next day for follow up. The research team was unable to contact some families for follow up, therefore the number of patients assessed for Other Adverse Events is smaller than those assessed for Serious Adverse Events.	6.5% 3/46 • Number of events 3 • Patients were assessed for serious events immediately following venipuncture and then the next day via phone follow up. All patients were assessed for serious adverse events in the lab. Attempts were made to contact the families of all patients the next day for follow up. The research team was unable to contact some families for follow up, therefore the number of patients assessed for Other Adverse Events is smaller than those assessed for Serious Adverse Events.	1.2% 1/83 • Number of events 1 • Patients were assessed for serious events immediately following venipuncture and then the next day via phone follow up. All patients were assessed for serious adverse events in the lab. Attempts were made to contact the families of all patients the next day for follow up. The research team was unable to contact some families for follow up, therefore the number of patients assessed for Other Adverse Events is smaller than those assessed for Serious Adverse Events.

Additional Information

Maren Lunoe

Medical College of Wisconsin

Phone: 414-266-2625

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place