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

NCT00924963 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2020-09-21

No results posted yet for this study

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

Interventions

DEVICE

J-Tip jet injector

0.2ml 1%buffered lidocaine delivered by jet injector

DEVICE

Jet injection saline

0.2ml saline delivered via J-Tip jet injection

DRUG

lidocaine cream

4% lidocaine cream applied for 30 minutes to the skin

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Stephanie L Spanos, MD · Children's Hospital Medical Center, Cincinnati

  • Srikant Iyer, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00924963 on ClinicalTrials.gov