J-Tip® Jet Injection of 1% Buffered Lidocaine or Saline Versus 4% Lidocaine Cream Before Venipuncture or IV Insertion

NCT00924963 | Withdrawn Early Phase 1 DMC

• 1 other identifier: 2008-0922
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To measure and compare pain associated with venipuncture and peripheral intravenous catheter insertion among pediatric emergency department patients randomized to treatment with one of three different pain-reduction strategies: J-Tip® jet injection of 1% buffered lidocaine, J-Tip® jet injection of sterile saline, or application of 4% lidocaine topical cream. The investigators hypothesize that J-Tip® jet injection of 1% buffered lidocaine will provide superior local anesthesia compared to saline or lidocaine cream.

Conditions

Pain

Keywords

Pain of venipuncture or IV insertion

Outcome Measures

Primary Outcomes (1)

• Jet injection of 1% buffered lidocaine to 4% lidocaine topical cream to measure the effectiveness of jet injection of lidocaine as a local anesthetic prior to venipuncture and PIVC insertion

  1\. Pain associated with venipuncture or PIVC insertion after pre-treatment with jet injection of 1% buffered lidocaine versus 4% lidocaine topical cream

  30 minutes

Secondary Outcomes (5)

• Jet injection of 1% buffered lidocaine to jet injection of saline to assess and measure a potential placebo effect not measured in prior studies

  30 minutes

• Second attempt pain scores (if occurred) among the three groups and between their first and second VAS scores

  30 minutes

• The success of venipuncture or PIVC insertion with all anesthetic techniques

  30 minutes

• Variety of locations of successful venipuncture or PIVC insertion after jet injection use

  30 minutes

• Measurement of complication rate after jet injection use

  1 hour

Study Arms (3)

Jet injection lidocaine

EXPERIMENTAL

J-Tip jet injection of 1% buffered lidocaine

Device: J-Tip jet injector

Jet injection saline

PLACEBO COMPARATOR

J-Tip jet injection of sterile saline

Device: Jet injection saline

Lidocaine cream

ACTIVE COMPARATOR

Lidocaine 4%cream applied for 30 minutes prior to IV insertion or venipuncture

Drug: lidocaine cream

Interventions

J-Tip jet injector DEVICE

0.2ml 1%buffered lidocaine delivered by jet injector

Also known as: J-Tip jet injector with 1% buffered lidocaine

Jet injection lidocaine

Jet injection saline DEVICE

0.2ml saline delivered via J-Tip jet injection

Also known as: J-Tip Jet injection with saline

Jet injection saline

lidocaine cream DRUG

4% lidocaine cream applied for 30 minutes to the skin

Also known as: 4% lidocaine cream

Lidocaine cream

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged seven to twenty-one years old requiring venipuncture or PIVC insertion as part of their emergency department care are eligible for the study.

You may not qualify if:

• Lidocaine allergy,
• TegadermTM allergy,
• Glasgow Coma Score (GCS) less than 15,
• Pain at the proposed site for the procedure,
• Requirement of a PIVC or venipuncture immediately due to illness acuity,
• Inability to complete a self-reported pain scale (VAS, visual analogue scale),
• Patients who do not speak and understand English, OR
• Previous enrollment in the study.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Liberty Township Emergency Department

Liberty Township, Ohio, 45044, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephanie L Spanos, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Srikant Iyer, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: June 19, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 21, 2020

Record last verified: 2020-09

Locations

US (1)