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

Study Overview
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Brief Summary
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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.

Detailed Description
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No change since last report.

Official Title
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Use Of The Needle Free Jet-Injection System With Buffered Lidocaine (J-Tip) For The Treatment Of Pain During Venipuncture For Blood Draws In Young Children

Conditions
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Pain

Intervention / Treatment
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* Device: J tip
* Other: Pain Ease Spray
* Drug: 1% buffered lidocaine
* Other: placebo cooling spray (normal saline spray)
* Other: Sucrose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: J tip Noise<br>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 | Device: J tip<br>* This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine<br>Other: Pain Ease Spray<br>* Cold Spray used to anesthetize the skin<br>* Other names: Cooling Spray;Other: Sucrose<br>* Oral Sucrose used for children < 1 year<br>* Other names: Sweetease;|
| Other: Pain Ease<br>This group will receive Pain Ease Spray only if > 1 yr or sucrose only if child < 1 yr | Other: Pain Ease Spray<br>* Cold Spray used to anesthetize the skin<br>* Other names: Cooling Spray;Other: Sucrose<br>* Oral Sucrose used for children < 1 year<br>* Other names: Sweetease;|
| Experimental: J tip<br>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 | Device: J tip<br>* This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine<br>Drug: 1% buffered lidocaine<br>* Lidocaine placed using Jet Injection<br>* Other names: Lidocaine;Other: placebo cooling spray (normal saline spray)<br>* Normal Saline Sprayed as placebo for Pain Ease spray<br>* Other names: Normal Saline Spray;Other: Sucrose<br>* Oral Sucrose used for children < 1 year<br>* Other names: Sweetease;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Children, Venipuncture, J tip, Lidocaine, video observation