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
Overview
- Phase
- N/A
- Intervention
- J tip
- Conditions
- Pain
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 205
- Locations
- 1
- Primary Endpoint
- Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture
- Status
- Completed
- Last Updated
- 10 years ago
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.
Investigators
Eligibility Criteria
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
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
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
Pain Ease
This group will receive Pain Ease Spray only if \> 1 yr or sucrose only if child \< 1 yr
Intervention: Pain Ease Spray
Pain Ease
This group will receive Pain Ease Spray only if \> 1 yr or sucrose only if child \< 1 yr
Intervention: Sucrose
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
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
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)
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
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)