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

September 2, 2015 updated by: Medical College of Wisconsin

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

No change since last report.

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: 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
Device: J tip
This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
Other: Pain Ease Spray
Cold Spray used to anesthetize the skin
Other Names:
  • Cooling Spray
Other: Sucrose
Oral Sucrose used for children < 1 year
Other Names:
  • Sweetease
OTHER: Pain Ease
This group will receive Pain Ease Spray only if > 1 yr or sucrose only if child < 1 yr
Other: Pain Ease Spray
Cold Spray used to anesthetize the skin
Other Names:
  • Cooling Spray
Other: Sucrose
Oral Sucrose used for children < 1 year
Other Names:
  • Sweetease
EXPERIMENTAL: 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
Device: J tip
This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
Other: Sucrose
Oral Sucrose used for children < 1 year
Other Names:
  • Sweetease
Drug: 1% buffered lidocaine
Lidocaine placed using Jet Injection
Other Names:
  • Lidocaine
Other: placebo cooling spray (normal saline spray)
Normal Saline Sprayed as placebo for Pain Ease spray
Other Names:
  • Normal Saline Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At venipuncture (3 minutes)
Fist Attempt Success
Time Frame: up to 3 minutes
Proportion of patients where blood draw was successful on first attempt
up to 3 minutes
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.
3 min
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.
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Maren Lunoe, MD, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

July 1, 2013

First Posted (ESTIMATE)

July 2, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 6, 2015

Last Update Submitted That Met QC Criteria

September 2, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 443133-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on J tip

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe