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

This study has been completed.
Sponsor:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00681902
First received: May 19, 2008
Last updated: February 4, 2009
Last verified: February 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Provider and patient satisfaction. [ Time Frame: Secondary outcome was measured at time of initial needlestick in ED. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   5 Years to 19 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: May 19, 2008
Last Updated: February 4, 2009
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

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014