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

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ClinicalTrials.gov Identifier: NCT01890642

Recruitment Status : Completed

First Posted : July 2, 2013

Results First Posted : October 6, 2015

Last Update Posted : October 6, 2015

Sponsor:

Information provided by (Responsible Party):

Medical College of Wisconsin

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Device: J tip Other: Pain Ease Spray Drug: 1% buffered lidocaine Other: placebo cooling spray (normal saline spray) Other: Sucrose	Not Applicable

Detailed Description:

No change since last report.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	205 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
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
Study Start Date :	July 2013
Actual Primary Completion Date :	August 2013
Actual Study Completion Date :	August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

Arms and Interventions

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 Name: Cooling Spray Other: Sucrose Oral Sucrose used for children < 1 year Other Name: Sweetease
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 Name: Cooling Spray Other: Sucrose Oral Sucrose used for children < 1 year Other Name: 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 Drug: 1% buffered lidocaine Lidocaine placed using Jet Injection Other Name: Lidocaine Other: placebo cooling spray (normal saline spray) Normal Saline Sprayed as placebo for Pain Ease spray Other Name: Normal Saline Spray Other: Sucrose Oral Sucrose used for children < 1 year Other Name: Sweetease

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.
Fist Attempt Success [ Time Frame: up to 3 minutes ]
Proportion of patients where blood draw was successful on first attempt
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.
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.

Eligibility Criteria

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Ages Eligible for Study:	6 Months to 6 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890642

Locations

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

Sponsors and Collaborators

Medical College of Wisconsin

Investigators

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Principal Investigator:	Maren Lunoe, MD	Medical College of Wisconsin
Principal Investigator:	Amy Drendel, DO, MS	Medical College of Wisconsin

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lunoe MM, Bolin AE, Drendel AL. An Evaluation of High Preprocedural Anxiety and Venipuncture Pain Experienced by Young Children. Pediatr Emerg Care. 2021 Oct 1;37(10):e621-e624. doi: 10.1097/PEC.0000000000002424.

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Responsible Party:	Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT01890642
Other Study ID Numbers:	443133-1
First Posted:	July 2, 2013 Key Record Dates
Results First Posted:	October 6, 2015
Last Update Posted:	October 6, 2015
Last Verified:	September 2015

Keywords provided by Medical College of Wisconsin:


Pain Children Venipuncture	J tip Lidocaine video observation

Additional relevant MeSH terms:

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Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents	Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

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