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

Medical College of Wisconsin205 enrolled

Overview

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.

No change since last report.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

205

Conditions

Pain

Interventions

J tipDEVICE

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

Pain Ease SprayOTHER

Cold Spray used to anesthetize the skin

1% buffered lidocaineDRUG

Lidocaine placed using Jet Injection

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture

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.

Time frame: 3 min

Secondary Outcomes

Pain Score

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.

Time frame: At venipuncture (3 minutes)

Fist Attempt Success

Proportion of patients where blood draw was successful on first attempt

Time frame: up to 3 minutes

Change in Pain Score From Baseline

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.

Time frame: 3 min

Pain at J-tip Deployment

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.

Time frame: 1 minute

Data from ClinicalTrials.gov

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