Skip to main content
OpenTrials
Completed

NCT Number: NCT01890642

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

No change since last report.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

J tip

Device

This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine

Pain Ease Spray

Other

Cold Spray used to anesthetize the skin

Other names: Cooling Spray

1% buffered lidocaine

Drug

Lidocaine placed using Jet Injection

Other names: Lidocaine

placebo cooling spray (normal saline spray)

Other

Normal Saline Sprayed as placebo for Pain Ease spray

Other names: Normal Saline Spray

Sucrose

Other

Oral Sucrose used for children < 1 year

Other names: Sweetease

Primary outcomes

  1. 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

  1. Pain Score

    Time frame: At venipuncture (3 minutes)

    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.

  2. Fist Attempt Success

    Time frame: up to 3 minutes

    Proportion of patients where blood draw was successful on first attempt

  3. Change in Pain Score From Baseline

    Time frame: 3 min

    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.

  4. Pain at J-tip Deployment

    Time frame: 1 minute

    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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 2, 2013
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.