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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 205
- Locations
- 1
- Primary Endpoint
- Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Months to 6 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
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 if > age 1 yr or sucrose if < 1 yr
Intervention: J tip (Device)
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 if > age 1 yr or sucrose if < 1 yr
Intervention: Pain Ease Spray (Other)
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 if > age 1 yr or sucrose if < 1 yr
Intervention: Sucrose (Other)
Pain Ease
This group will receive Pain Ease Spray only if > 1 yr or sucrose only if child < 1 yr
Intervention: Pain Ease Spray (Other)
Pain Ease
This group will receive Pain Ease Spray only if > 1 yr or sucrose only if child < 1 yr
Intervention: Sucrose (Other)
J tip
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
Intervention: J tip (Device)
J tip
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
Intervention: 1% buffered lidocaine (Drug)
J tip
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
Intervention: placebo cooling spray (normal saline spray) (Other)
J tip
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
Intervention: Sucrose (Other)
Outcomes
Primary Outcomes
Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture
Time Frame: 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 Outcomes
- Pain Score(At venipuncture (3 minutes))
- Fist Attempt Success(up to 3 minutes)
- Change in Pain Score From Baseline(3 min)
- Pain at J-tip Deployment(1 minute)