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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681902
First Posted: May 21, 2008
Last Update Posted: February 6, 2009
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.
Information provided by:
New York University School of Medicine
  Purpose
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 Intervention
Pain Drug: Lidocaine Drug: Placebo

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

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

Enrollment: 150
Study Start Date: March 2007
Study Completion Date: July 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

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


Locations
United States, New York
Bellevue Hospital
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
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 Submitted: May 19, 2008
First Posted: May 21, 2008
Last Update Posted: February 6, 2009
Last Verified: February 2009

Keywords provided by New York University School of Medicine:
Pediatric
Pain
Needle
Emergency
Phlebotomy
Intravenous
Lidocaine
Local
Anesthesia

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
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