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

Medical College of Wisconsin logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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