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

Medical College of Wisconsin

Status: Completed

Conditions: Pain

Treatments: Device: J tip; Other: placebo cooling spray (normal saline spray); Other: Sucrose; Drug: 1% buffered lidocaine; Other: Pain Ease Spray

Study type: Interventional

Funder types: Other

Identifiers

NCT01890642

443133-1

Details and patient eligibility

About

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.

Full description

No change since last report.

Enrollment: 205 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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205 participants in 3 patient groups

J tip Noise

Sham Comparator group

Description:

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

Treatment:

Other: Pain Ease Spray

Other: Sucrose

Device: J tip

Pain Ease

Other group

Description:

This group will receive Pain Ease Spray only if > 1 yr or sucrose only if child < 1 yr

Treatment:

Other: Pain Ease Spray

Other: Sucrose

J tip

Experimental group

Description:

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

Treatment:

Drug: 1% buffered lidocaine

Other: Sucrose

Other: placebo cooling spray (normal saline spray)

Device: J tip