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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: J tip; Other: Pain Ease Spray; Drug: 1% buffered lidocaine; Other: Sucrose; Other: placebo cooling spray (normal saline spray)

• Registration Number: NCT01890642
• Lead Sponsor: Medical College of Wisconsin

Brief 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.

Detailed Description

No change since last report.

Study Timeline

• Study First Submitted: 2013-06-24
• Study Start: 2013-07
• Study First Submitted QC: 2013-07-01
• Study First Posted: 2013-07-02
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2015-05-22
• Status Verified: 2015-09
• Results First Submitted QC: 2015-09-02
• Last Update Submitted: 2015-09-02
• Results First Posted: 2015-10-06
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
J tip Noise	J tip	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
J tip Noise	Pain Ease Spray	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
J tip Noise	Sucrose	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
Pain Ease	Pain Ease Spray	This group will receive Pain Ease Spray only if \> 1 yr or sucrose only if child \< 1 yr
Pain Ease	Sucrose	This group will receive Pain Ease Spray only if \> 1 yr or sucrose only if child \< 1 yr
J tip	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
J tip	1% buffered lidocaine	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
J tip	placebo cooling spray (normal saline spray)	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
J tip	Sucrose	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

Primary Outcome Measures

Name	Time	Method
Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture	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 Outcome Measures

Name	Time	Method
Pain Score	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.
Fist Attempt Success	up to 3 minutes	Proportion of patients where blood draw was successful on first attempt
Change in Pain Score From Baseline	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.
Pain at J-tip Deployment	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.

Trial Locations

Locations (1)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States