Pain
Conditions
Keywords
Pain, Children, Venipuncture, J tip, Lidocaine, video observation
Brief summary
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.
Detailed description
No change since last report.
Interventions
DEVICEJ tip
This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
OTHERPain Ease Spray
Cold Spray used to anesthetize the skin
DRUG1% buffered lidocaine
Lidocaine placed using Jet Injection
OTHERplacebo cooling spray (normal saline spray)
Normal Saline Sprayed as placebo for Pain Ease spray
OTHERSucrose
Oral Sucrose used for children \< 1 year
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged 6 months-6 years seen in the Children's Hospital of Wisconsin outpatient laboratory that have an order for venipuncture for a blood draw
Exclusion criteria
* Previous adverse reaction to lidocaine or Pain Ease spray * Pre-existing skin lesion at site of blood draw * Needle stick for IV insertion or lab draw that has already occurred at current hospital visit * Patients who are physically unable to move their arms or legs * Patients who are unable to cry * Patients with connective tissue disorders that predispose to easy bruising * Patients with bleeding disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture | 3 min | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 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. |
| Fist Attempt Success | up to 3 minutes | Proportion of patients where blood draw was successful on first attempt |
| Change in Pain Score From Baseline | 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. |
| Pain at J-tip Deployment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 56 |
| Pain Ease This group will receive Pain Ease Spray
Pain Ease Spray: Cold Spray used to anesthetize the skin | 53 |
| 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 | 96 |
| Total | 205 |
Baseline characteristics
| Characteristic | J Tip Noise | Pain Ease | J Tip | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 56 Participants | 53 Participants | 96 Participants | 205 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3.4 years STANDARD_DEVIATION 1.6 | 2.9 years STANDARD_DEVIATION 1.7 | 3.3 years STANDARD_DEVIATION 1.9 | 3.2 years STANDARD_DEVIATION 1.7 |
| Previous Venipuncture | 55 participants | 51 participants | 96 participants | 202 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 9 Participants | 21 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 3 Participants | 16 Participants | 25 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 9 Participants | 12 Participants | 29 Participants |
| Race (NIH/OMB) White | 34 Participants | 31 Participants | 45 Participants | 110 Participants |
| Region of Enrollment United States | 56 participants | 53 participants | 96 participants | 205 participants |
| Sex: Female, Male Female | 25 Participants | 16 Participants | 42 Participants | 83 Participants |
| Sex: Female, Male Male | 31 Participants | 37 Participants | 54 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 46 | 6 / 46 | 13 / 83 |
| serious Total, serious adverse events | 0 / 56 | 0 / 53 | 0 / 96 |
Outcome results
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.
Time frame: 3 min
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| J Tip Noise | Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture | 1.71 units on a scale | Standard Error 0.42 |
| Pain Ease | Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture | 2.82 units on a scale | Standard Error 0.45 |
| J Tip | Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture | 0.23 units on a scale | Standard Error 0.28 |
p-value: 0.0001Kruskal-Wallis
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.
Time frame: 3 min
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| J Tip Noise | Change in Pain Score From Baseline | 2.32 units on a scale | Standard Error 0.48 |
| Pain Ease | Change in Pain Score From Baseline | 3.7 units on a scale | Standard Error 0.49 |
| J Tip | Change in Pain Score From Baseline | 1.58 units on a scale | Standard Error 0.31 |
p-value: 0.004Kruskal-Wallis
Secondary
Fist Attempt Success
Proportion of patients where blood draw was successful on first attempt
Time frame: up to 3 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| J Tip Noise | Fist Attempt Success | 52 participants |
| Pain Ease | Fist Attempt Success | 48 participants |
| J Tip | Fist Attempt Success | 86 participants |
p-value: 0.8Kruskal-Wallis
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.
Time frame: 1 minute
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| J Tip Noise | Pain at J-tip Deployment | 3.25 units on a scale |
| Pain Ease | Pain at J-tip Deployment | 2.5 units on a scale |
| J Tip | Pain at J-tip Deployment | 4.0 units on a scale |
p-value: 0.37Kruskal-Wallis
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.
Time frame: At venipuncture (3 minutes)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| J Tip Noise | Pain Score | 5.75 units on a scale |
| Pain Ease | Pain Score | 8 units on a scale |
| J Tip | Pain Score | 5.25 units on a scale |
p-value: 0.01Kruskal-Wallis