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This study looks at the use of Jet Injection Lidocaine (J tip) for pain during blood draws in children ages 6 and younger. The investigators will use video observation of patients to asses their pain during lab draws using either 1) Jet Injected lidocaine ( J tip) 2) Pain Ease spray 3) Pain Ease spray plus the J tip noise.
No change since last report.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| J tip Noise | Sham Comparator | 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 if > age 1 yr or sucrose if < 1 yr |
|
| Pain Ease | Other | This group will receive Pain Ease Spray only if > 1 yr or sucrose only if child < 1 yr |
|
| J tip | Experimental | This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding if > 1 yr and will receive sucrose is < 1 yr |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| J tip | Device | This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture | 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. | 3 min |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | 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. | At venipuncture (3 minutes) |
| Fist Attempt Success |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maren Lunoe, MD | Medical College of Wisconsin | Principal Investigator |
| Amy Drendel, DO, MS | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34591812 | Derived | Lunoe MM, Bolin AE, Drendel AL. An Evaluation of High Preprocedural Anxiety and Venipuncture Pain Experienced by Young Children. Pediatr Emerg Care. 2021 Oct 1;37(10):e621-e624. doi: 10.1097/PEC.0000000000002424. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Pain Ease | This group will receive Pain Ease Spray Pain Ease Spray: Cold Spray used to anesthetize the skin |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Pain Score | 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. | Posted | Median | Inter-Quartile Range | units on a scale | At venipuncture (3 minutes) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruise present at 24 hours | Skin and subcutaneous tissue disorders | Bruise | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maren Lunoe | Medical College of Wisconsin | 414-266-2625 | mlunoe@mcw.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Pain Ease Spray | Other | Cold Spray used to anesthetize the skin |
|
|
| 1% buffered lidocaine | Drug | Lidocaine placed using Jet Injection |
|
|
| placebo cooling spray (normal saline spray) | Other | Normal Saline Sprayed as placebo for Pain Ease spray |
|
|
| Sucrose | Other | Oral Sucrose used for children < 1 year |
|
|
Proportion of patients where blood draw was successful on first attempt
| up to 3 minutes |
| Change in Pain Score From Baseline | 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. | 3 min |
| Pain at J-tip Deployment | 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. | 1 minute |
| Pain Ease |
This group will receive Pain Ease Spray Pain Ease Spray: Cold Spray used to anesthetize the skin |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Previous Venipuncture | Reported Previous Venipuncture Experience. 3 parents stated they did not know if their child had previous venipuncture, accounting for the difference between the number enrolled in the study and the number on which this variable was collected. | Number | participants |
|
| OG002 | 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 |
|
|
|
| Secondary | Fist Attempt Success | Proportion of patients where blood draw was successful on first attempt | Posted | Number | participants | up to 3 minutes |
|
|
|
|
| Secondary | Change in Pain Score From Baseline | 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. | Posted | Mean | Standard Error | units on a scale | 3 min |
|
|
|
|
| Primary | Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture | 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. | Posted | Mean | Standard Error | units on a scale | 3 min |
|
|
|
|
| Secondary | Pain at J-tip Deployment | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 1 minute |
|
|
|
|
| 0 |
| 56 |
| 6 |
| 46 |
| EG001 | Pain Ease | This group will receive Pain Ease Spray Pain Ease Spray: Cold Spray used to anesthetize the skin | 0 | 53 | 6 | 46 |
| EG002 | 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 | 0 | 96 | 13 | 83 |
| Redness | Skin and subcutaneous tissue disorders | Redness | Systematic Assessment |
|
| Other/Not Specified | Injury, poisoning and procedural complications | Other | Systematic Assessment |
|
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| Aniline Compounds |
| D000588 | Amines |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |