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

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890642
• Other study ID #: 443133-1
• Status: Completed
• Phase: N/A
• First received: June 24, 2013
• Last updated: September 2, 2015
• Start date: July 2013
• Est. completion date: August 2013

Study information

• Verified date: September 2015
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

No change since last report.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 6 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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

Drug:
• 1% buffered lidocaine
Lidocaine placed using Jet Injection

Other:
• placebo cooling spray (normal saline spray)
Normal Saline Sprayed as placebo for Pain Ease spray
• Sucrose
Oral Sucrose used for children < 1 year

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 min	No
Secondary	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.	At venipuncture (3 minutes)	No
Secondary	Fist Attempt Success	Proportion of patients where blood draw was successful on first attempt	up to 3 minutes	No
Secondary	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.	3 min	No
Secondary	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.	1 minute	No