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

NCT01890642 | Completed Results DMC

• 1 other identifier: 443133-1
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain; Children; Venipuncture; J tip; Lidocaine; video observation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Pain Score

  At venipuncture (3 minutes)

• Fist Attempt Success

  up to 3 minutes

• Change in Pain Score From Baseline

  3 min

• Pain at J-tip Deployment

  1 minute

Study Arms (3)

J tip Noise

SHAM COMPARATOR

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; Other: Pain Ease Spray; Other: Sucrose

Pain Ease

OTHER

This group will receive Pain Ease Spray only if \> 1 yr or sucrose only if child \< 1 yr

Other: Pain Ease Spray; Other: Sucrose

J tip

EXPERIMENTAL

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; Drug: 1% buffered lidocaine; Other: placebo cooling spray (normal saline spray); Other: Sucrose

Interventions

J tip DEVICE

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

J tip; J tip Noise

Pain Ease Spray OTHER

Cold Spray used to anesthetize the skin

Also known as: Cooling Spray

J tip Noise; Pain Ease

1% buffered lidocaine DRUG

Lidocaine placed using Jet Injection

Also known as: Lidocaine

J tip

placebo cooling spray (normal saline spray) OTHER

Normal Saline Sprayed as placebo for Pain Ease spray

Also known as: Normal Saline Spray

J tip

Sucrose OTHER

Oral Sucrose used for children \< 1 year

Also known as: Sweetease

J tip; J tip Noise; Pain Ease

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 34591812 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Sucrose

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Results Point of Contact

• Title: Maren Lunoe
• Organization: Medical College of Wisconsin

mlunoe@mcw.edu

414-266-2625

Study Officials

• Maren Lunoe, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Amy Drendel, DO, MS

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: July 2, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 6, 2015
• Results First Posted: October 6, 2015

Record last verified: 2015-09

Locations

US (1)