We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Jet Lidocaine for Pain Relief During Needle Insertion in a Pediatric Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00681902
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : February 6, 2009
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to explore to what degree, if any, Jet lidocaine will reduce or alleviate pain, as compared to Jet normal saline, in children undergoing needle insertion in the Pediatric Emergency Department (PED). If effective, Jet lidocaine would afford a novel rapidly acting local anesthesic for children in the PED.

Condition or disease Intervention/treatment
Pain Drug: Lidocaine Drug: Placebo

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Jet Lidocaine for Pain Relief During Needle Insertion in a Pediatric Emergency Department.
Study Start Date : March 2007
Primary Completion Date : November 2007
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Jet lidocaine
Drug: Lidocaine
Jet lidocaine compared to jet placebo before needle insertion
Other Name: National medical jet injector system
Placebo Comparator: 2
Jet saline
Drug: Placebo
Jet saline

Outcome Measures

Primary Outcome Measures :
  1. Pain, the primary outcome, will be assessed using the Color Analogue pain Scale before and after needle insertion in each group and compared for a clinically significant difference. [ Time Frame: Primary outcome was measured at time of initial needlestick in ED ]

Secondary Outcome Measures :
  1. Provider and patient satisfaction. [ Time Frame: Secondary outcome was measured at time of initial needlestick in ED. ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   5 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age 5 - 18 years
  2. Evaluation and treatment requiring needle insertion in <60 minutes (Patient is not a candidate for EMLA cream)
  3. Parent or patient consent, and child assent

Exclusion Criteria:

  1. Age <5 years or >18 years
  2. Children eligible for or receiving EMLA cream
  3. Significant blunt or penetrating trauma requiring rapid evaluation/resuscitation (GCS<15)
  4. Unstable shock
  5. Altered sensorium or intoxication
  6. History of allergy to Lidocaine
  7. Neurologic deficit involving a lack of sensation in area of insertion
  8. Developmental delay so as not to understand pain scale
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): NCT00681902

United States, New York
Bellevue Hospital
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Principal Investigator: Michael Mojica NYU/Bellevue
More Information

Responsible Party: Marc Auerbach, Fellow Pediatric Emergency Medicine, Department of Pediatrics, NYUSOM
ClinicalTrials.gov Identifier: NCT00681902     History of Changes
Other Study ID Numbers: 06-705
First Posted: May 21, 2008    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009

Keywords provided by New York University School of Medicine:

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Anesthetics, Local
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