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

This study is currently recruiting participants.

Verified by New York University School of Medicine, May 2008

Sponsored by:	New York University School of Medicine
Information provided by:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00681902

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

Drug Information available for: Sodium chloride Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Jet Lidocaine for Pain Relief During Needle Insertion in a Pediatric Emergency Department.

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: Entire study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Provider and patient satisfaction. [ Time Frame: Entire study. ] [ Designated as safety issue: No ]

Estimated Enrollment:	168
Study Start Date:	March 2007
Estimated Study Completion Date:	July 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Jet lidocaine	Drug: Lidocaine Jet lidocaine compared to jet placebo before needle insertion
2: Placebo Comparator Jet saline	Drug: Placebo Jet saline

Show Detailed Description

Eligibility

Ages Eligible for Study:	5 Years to 19 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681902

Locations

United States, New York
Bellevue Hospital	Recruiting
New York, New York, United States, 10016
Contact: Michael Mojica, MD 212-562-3025
Contact: Michael Tunik, MD
Sub-Investigator: Marc Auerbach, MD
Sub-Investigator: Michael Tunik, MD

Sponsors and Collaborators

New York University School of Medicine

Investigators

Principal Investigator:

Michael Mojica

NYU/Bellevue

More Information

Responsible Party:	Department of Pediatrics, NYUSOM ( Marc Auerbach, Fellow Pediatric Emergency Medicine )
Study ID Numbers:	06-705
Study First Received:	May 19, 2008
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00681902
Health Authority:	United States: Institutional Review Board

Keywords provided by New York University School of Medicine:

Pediatric
Pain
Needle
Emergency
Phlebotomy

Intravenous
Lidocaine
Local
Anesthesia

Study placed in the following topic categories:

Lidocaine
Emergencies
Pain

Additional relevant MeSH terms:

Disease Attributes
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Cardiovascular Agents
Anesthetics, Local
Pharmacologic Actions

Pathologic Processes
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009